Premier Research
A global clinical research organization.We’re out to change the course of medical science. Are you ready to rise to the challenge? Premier Research is not about being everything to everyone. Instead, our deep, focused expertise targets the therapeutic areas and indications where today’s biotech and specialty pharma pioneers are doing the most amazing work. We’re 1,500 employees strong and operate in more than 20 countries, delivering unmatched expertise, operational skills, and dedication to meeting customers’ most challenging needs.
Headquarter Location:
Morrisville, North Carolina, USA
Premier Research is hiring a Remote Clinical Trial Associate II - Contractor
Description
Premier Research is looking for a Clinical Trial Associate II (Contractor) to join our Functional Services team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
This is a 1 year full time remote-based contract position.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you'll be doing:
- Supports the study team with document collection, as requested
- Assists in the dissemination of announcements and training materials related to clinical system updates and enhancements, as required
- Participates in project team meetings, prepares meeting minutes, and maintains action/decision logs
- Facilitates process management and periodic review of of SOPs and WPs
- Tracks non-TMF documents and ensures finalized content is routed through appropriate approval channels
- Reports document collection and tracking issues to functional lead and/or study team, as required
What we are searching for:
- Bachelor’s degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience
- 2+ years of practical experience with clinical trial administration (e.g. – Inhouse CRA, CTA, site administration, clinical monitoring) preferred
- Demonstrates excellent English verbal and written communication skills
- Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.
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Premier Research is hiring a Remote Site Solutions Executive- Mysuru (Kannada )
Description
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Site Solution Executive to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
What you will be doing:
To coordinate and facilitate all Clinical trial activities at site ensuring compliance with protocol, applicable GCP guidelines and local regulations ;
• To support Principal Investigator (PI) and site study team assuring that the clinical trial(s) being conducted meet all the criteria set by the sponsors and regulators
• To fulfil the duties and responsibilities stated above, the SSE will perform the following functions: ― Performs timely data entry of the Case Record Forms (CRF) or Electronic CRF (eCRF) in consultation with the PI/ Investigator
- Maintaining clinical trial-related documents at site including Trial Master File.
― Preparing for, facilitating and assisting at site initiation, monitoring and close-out visits, protocol-prescribed and other necessary patient-visits, QA visits, sponsor visits and Inspections.
― Reporting site-performance metrics at pre-determined frequency.
― Coordinating submissions to ethics committee of protocol, adverse events and periodic study reports for review and ensuring that all documentation to and from ethics committee is appropriately maintained.
• To coordinate and support clinical trial activities related to a study or studies at a site or sites
• To support partnering and growth opportunities within the site(s) or location of the sites
― Assisting in scheduling patient investigations and assessments per instructions of Principal Investigator
― Ensuring timely availability of IP and Lab kits and other clinical trial supplies and ensuring IP is appropriately stored, maintaining temperature logs where necessary; also maintaining IP accountability and accurate record of all clinical trial supplies including lab kits; dispensing of IP to subjects per the protocol under the supervision of the PI
― Assuring that all work at site prescribed by the approved protocol, the contract and the EC is performed in a timely and comprehensive manner
― Organizing and coordinating laboratory sample pick-ups and reporting
― Transcribing source documents if required under the supervision of the PI or designated person and ensuring that they are reviewed and signed off by the responsible person.
― Assisting in timely resolution of data queries
― Coordinating and supporting timely completion of protocol-related procedures by the PI, specifically subject scheduling, subject screening and enrolment
― Maintaining regular contact with site monitor regarding patient enrolment, visit scheduling, dosing/ dispensing
― Facilitating cordial and timely communication between investigator and sponsor/ CRO
― Supporting patient-awareness, training or other events at site or in the neighborhood
― Supporting data collection activity at site including but not limited to feasibilities, epidemiological data
What you will be doing:
To coordinate and facilitate all Clinical trial activities at site ensuring compliance with protocol, applicable GCP guidelines and local regulations ;
• To support Principal Investigator (PI) and site study team assuring that the clinical trial(s) being conducted meet all the criteria set by the sponsors and regulators
• To fulfil the duties and responsibilities stated above, the SSE will perform the following functions: ― Performs timely data entry of the Case Record Forms (CRF) or Electronic CRF (eCRF) in consultation with the PI/ Investigator
- Maintaining clinical trial-related documents at site including Trial Master File.
― Preparing for, facilitating and assisting at site initiation, monitoring and close-out visits, protocol-prescribed and other necessary patient-visits, QA visits, sponsor visits and Inspections.
― Reporting site-performance metrics at pre-determined frequency.
― Coordinating submissions to ethics committee of protocol, adverse events and periodic study reports for review and ensuring that all documentation to and from ethics committee is appropriately maintained.
• To coordinate and support clinical trial activities related to a study or studies at a site or sites
• To support partnering and growth opportunities within the site(s) or location of the sites
― Assisting in scheduling patient investigations and assessments per instructions of Principal Investigator
― Ensuring timely availability of IP and Lab kits and other clinical trial supplies and ensuring IP is appropriately stored, maintaining temperature logs where necessary; also maintaining IP accountability and accurate record of all clinical trial supplies including lab kits; dispensing of IP to subjects per the protocol under the supervision of the PI
― Assuring that all work at site prescribed by the approved protocol, the contract and the EC is performed in a timely and comprehensive manner
― Organizing and coordinating laboratory sample pick-ups and reporting
― Transcribing source documents if required under the supervision of the PI or designated person and ensuring that they are reviewed and signed off by the responsible person.
― Assisting in timely resolution of data queries
― Coordinating and supporting timely completion of protocol-related procedures by the PI, specifically subject scheduling, subject screening and enrolment
― Maintaining regular contact with site monitor regarding patient enrolment, visit scheduling, dosing/ dispensing
― Facilitating cordial and timely communication between investigator and sponsor/ CRO
― Supporting patient-awareness, training or other events at site or in the neighborhood
― Supporting data collection activity at site including but not limited to feasibilities, epidemiological data
Why choose Premier Research?
- Why Choose Premier Research?
• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
See more jobs at Premier Research
Premier Research is hiring a Remote Associate Data Manager
Description
Premier Research is looking for anAssociate Data Manager to join our Functional Services team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you'll be doing:
- Assist in preparing clean databases by performing a review of clinical trial data to ensure all captured data follows the rules outlined by the protocol and Data Management Plan
- Provide input to and review of Data Management Plans in support of clinical study deliverables
- Review responses to queries for appropriateness, resolve any discrepancies, and modify the database accordingly
- Support data entry testing to ensure data can be input into the database as intended by the database design.
- Support query testing (edit checks) to determine data entered to a clinical database outside of expected values or ranges are prompted for further review.
- Assist in the user acceptance testing for study-specific data listings ensuring data output adheres with requirements
- Prepare and maintain documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made, as required
- Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience
- Preferred 1 to 2 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions.
- Demonstrates excellent English verbal and written communication skills
- Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)
- Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
- Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
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Premier Research is hiring a Remote TMF Lead I - Bulgaria
Description
Premier Research is looking for a TML Lead I to join our Global Records Management team. You will help biotech, MedTech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM .Join us and build your future here.
What you’ll be doing:
- Ensures personal utilization targets and study performance metrics are met
- Acts as primary point of contact for project teams, Sponsors, auditors and other external third parties on assigned studies/programs
- Supervises department team on assigned studies/programs as needed
- Ensures performance metrics are met and scope of work is performed according to budgets and timelines for assigned studies/programs for supervised staff as required
- Ensures that any out-of-scope activities are identified, reported to department management, itemized with project leadership and appropriately budgeted in change orders for assigned studies/programs
- Leads and/or assists management with department continuous improvement activities globally
- Supervises the security, environment and access control of Secure File Room (SFR) facilities located in their local office or region (if applicable)
- Oversees Project Team compliance to essential document management requirements, TMF SOPs and TMF Plans for assigned studies/programs and supervised staff
- Provides mentoring and training of new hires, project teams and external staff as needed
- Performs all departmental budgeted activities for assigned studies/programs
- Assists management with candidate review, interviews, hiring recommendations,
- Assists with on-boarding and training of department staff globally
- Serves as primary point of contact for programs and providing program level customer service and support for key Sponsor relationships
- Participates in business development presentations and system demonstrations, study KOMs and other targeted project team meetings globally as needed
- Performs eTMF System Administrator responsibilities as needed
What We Are Searching For:
- Undergraduate degree or international equivalent from an accredited institution majoring in records and information management, library science, clinical, science or health related field required - or – an equivalent level of clinical trials records management experience.
- 6+ years (of clinical trials essential document management and/or records management experience is required.
- Significant experience using computerized clinical trials records management technologies is required.
- Project, clinical and/or quality management experience preferred.
- Significant knowledge of ICH-GCP, ISO14155 and global regulations pertaining to essential document management and Trial Master File management is required.
Why Choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
#LI-KT1
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Premier Research is hiring a Remote Senior Project Manager, Rare Diseases
Description
Premier Research is looking for a Senior Project Manager to join ourRare Diseasesteam. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What You'll Be Doing:
- Ensuring successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
- Ensuring adherence to project budget and scope of work to realize project profitability
- Ensuring all project tasks are completed in accordance with project plans and in compliance with standard Premier Research processes, policies and procedures
- Ensuring effective communication is maintained and project status reports and monthly progress reports are provided both internally and externally
- Ensuring compliance for project-related training
- Ensuring adequate resourcing is available to meet project deliverables and milestones
What We're Searching For:
- Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
- Minimum 8 years relevant experience, preferably in a pharmaceutical company/medical device company/CRO, at least half of which has been in a matrix environment
- 5 years of experience serving as a Project Manager for complex and/or international clinical trials and/or programs
- Strong budget/finance experience on a project level
- Experience managing a study from start to completion, managing multiple phases, and managing the full lifecycle
- Rare Disease experience required
Why choose Premier?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
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Premier Research is hiring a Remote Senior Vice President, Regulatory Affairs
Description
Premier Consulting, a division of Premier Research, is seeking a Senior Vice President, Regulatory Affairs. Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors deliver results for patients and you are essential to this process.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Develops and implements strategic plans and objectives for organization growth in alignment with corporate strategy in delivery of high-quality regulatory services to clients and provide advice in support of clinical development planning.
- Provides leadership to teams in the preparation of regulatory strategies, review of clinical development plans, and health authority interactions for clients
- Key responsibility for building cross-functional alliances both within Premier Consulting as well with Premier Research. This includes advising internal development functions such as Clinical, Medical, Nonclinical and CMC regarding regulatory impact of development decisions
- Manages the organizational structure, staffing, resourcing, and supervision of the Global Regulatory Affairs function including line management responsibilities for multiple Regulatory Affairs sites and/or regions
- Supports Business Development efforts for opportunities including proposals, budgets, pitching calls and bid defense meetings
What we’re searching for:
- Bachelor’s degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred
- BA/BS and 16-18 years of related experience or MA and 14-16 years of related experience or PhD and 12-14 years of related experience in the pharmaceutical, CRO or biotechnology industry, involving the conduct of clinical trials.
- Minimum of 10-15 years’ experience of managing people or processes in the regulatory affairs department.
- Experience in the preparation of regulatory submissions in the US and Europe is required
- Experience with supervisory and financial management responsibility of a regulatory affairs department or component thereof (prior experience and responsibility for financial management of a regulatory department of a CRO, pharmaceutical or consulting firm)
- Experience working in multidisciplinary project teams
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federalguidelines. All qualified applicants will receive equitable consideration without regard to race,color, religion, sexual orientation, gender identity, national origin, disability or veteran status.
#LI-EC
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Premier Research is hiring a Remote Senior Biostatistical Programmer
Description
Premier Research is looking for a Senior Biostatistical Programmer to join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech. Join us and build your future here.
What you will be doing :
For project success:
· Keeps detailed records of time spent on each project for accurate billing
· Respects and maintains the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with
· Develops SAS programs to generate listings without shells
For commercial success:
· Develops and maintains overall awareness in the field of Biostatistical programming by attending training classes, professional meetings, following-up on technical developments, etc.
· Ensures that work is completed on time and at the correct level of quality
· Contributes to the tracking of project revenue and backlog
· Contributes to the tracking of hours worked on projects and forecasts hours to complete
Other
· Participates in efforts for efficiency and productivity in the department
· Performs other work-related duties as assigned
· Participate in corporate initiatives and actions that ensure the continued success of the company
· Attends project and corporate meetings as necessary
· Handles complicated or non-standard sources of data
· Other activities as designated
EDUCATION, SKILLS & COMPETENCIES:
Educational Background
· BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role
Experience
· 4-6 years of experience in SAS programming within the area of clinical trials.
· Prior experience using computerized information systems preferred.
· Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
Why Choose Premier Research?
• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
See more jobs at Premier Research
Premier Research is hiring a Remote Clinical Lead II / III
Description
At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.
We’re looking for a Clinical Lead II/III - Oncology to join our Clinical Management team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Provides coaching and mentoring to clinical staff, study team and external stakeholders and act as Ambassador for Clinical Management Group to internal and external stakeholders
- Manage clinical portion of the trial in a patient centric approach and proactively identifying risk, potential patient safety events, and maintain oversight for data integrity.
- Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct involvement in selection and activation of investigative sites; ensure the timely completion of all visit reports
- Drive the successful activation of trial sites according to time, quality/scope and budget parameters
- Plan and drive both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestone.
- Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock
- Deliver and coordinate appropriate and timely training to the Premier clinical team and enlist therapeutic assistance where applicable to ensure the validity, correctness, and completeness of the clinical data
- Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
- Actively participate in Bid Defense activities
You’ll need this to be considered:
- Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field
- 7 years+ of previous Clinical Oversight experience as a Clinical Lead
- 2 years + of onsite monitoring experience
- Rare Disease/Pediatrics experience is preferred
- Working knowledge of clinical financials including understanding of budgets, pass- through and resource management
- Experience on the CRO side is preferred
- Fluent verbal and written English as well as the local language(s) required
- Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites
- Excellent organizational and time-management skills, able prioritize work to meet deadlines
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-JD1
#Remote
#LI-JD1
#Remote
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Premier Research is hiring a Remote Senior Biostatistician (Contractor Czech Republic)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Hungary)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Poland)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Romania)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Slovakia)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Bulgaria)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Ukraine)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
+30d
Senior Biostatistical Programmer (Contractor Czech Republic)
Premier ResearchRemote,
Prague,
Czechia
Premier Research is hiring a Remote Senior Biostatistical Programmer (Contractor Czech Republic)
Description
Premier Research is looking for a Senior Biostatistical Programmer to join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you'll be doing:
- Develops SAS programs to generate listings without shells
- Develops and maintains overall awareness in the field of Biostatistical programming by attending training classes, professional meetings, following-up on technical developments, etc.
- Ensures that work is completed on time and at the correct level of quality
- Contributes to the tracking of project revenue and backlog
- Contributes to the tracking of hours worked on projects and forecasts hours to complete
- Participates in efforts for efficiency and productivity in the department
- Participate in corporate initiatives and actions that ensure the continued success of the company
- Handles complicated or non-standard sources of data
What we are searching for:
- BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role
- 4-6 years of experience in SAS programming within the area of clinical trials.
- Prior experience using computerized information systems preferred.
- Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
- Demonstrated working knowledge of data processing, database design and organization in clinical data environment
- Demonstrated working knowledge of basic clinical trial design and analysis principles
- Working knowledge of CDISC standards and application of these standards to projects
- Working knowledge and understanding of advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistical Programmer (Contractor Hungary)
Description
Premier Research is looking for a Senior Biostatistical Programmer to join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you'll be doing:
- Develops SAS programs to generate listings without shells
- Develops and maintains overall awareness in the field of Biostatistical programming by attending training classes, professional meetings, following-up on technical developments, etc.
- Ensures that work is completed on time and at the correct level of quality
- Contributes to the tracking of project revenue and backlog
- Contributes to the tracking of hours worked on projects and forecasts hours to complete
- Participates in efforts for efficiency and productivity in the department
- Participate in corporate initiatives and actions that ensure the continued success of the company
- Handles complicated or non-standard sources of data
What we are searching for:
- BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role
- 4-6 years of experience in SAS programming within the area of clinical trials.
- Prior experience using computerized information systems preferred.
- Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
- Demonstrated working knowledge of data processing, database design and organization in clinical data environment
- Demonstrated working knowledge of basic clinical trial design and analysis principles
- Working knowledge of CDISC standards and application of these standards to projects
- Working knowledge and understanding of advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistical Programmer (Contractor Romania)
Description
Premier Research is looking for a Senior Biostatistical Programmer to join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you'll be doing:
- Develops SAS programs to generate listings without shells
- Develops and maintains overall awareness in the field of Biostatistical programming by attending training classes, professional meetings, following-up on technical developments, etc.
- Ensures that work is completed on time and at the correct level of quality
- Contributes to the tracking of project revenue and backlog
- Contributes to the tracking of hours worked on projects and forecasts hours to complete
- Participates in efforts for efficiency and productivity in the department
- Participate in corporate initiatives and actions that ensure the continued success of the company
- Handles complicated or non-standard sources of data
What we are searching for:
- BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role
- 4-6 years of experience in SAS programming within the area of clinical trials.
- Prior experience using computerized information systems preferred.
- Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
- Demonstrated working knowledge of data processing, database design and organization in clinical data environment
- Demonstrated working knowledge of basic clinical trial design and analysis principles
- Working knowledge of CDISC standards and application of these standards to projects
- Working knowledge and understanding of advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistical Programmer (Contractor Slovakia)
Description
Premier Research is looking for a Senior Biostatistical Programmer to join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you'll be doing:
- Develops SAS programs to generate listings without shells
- Develops and maintains overall awareness in the field of Biostatistical programming by attending training classes, professional meetings, following-up on technical developments, etc.
- Ensures that work is completed on time and at the correct level of quality
- Contributes to the tracking of project revenue and backlog
- Contributes to the tracking of hours worked on projects and forecasts hours to complete
- Participates in efforts for efficiency and productivity in the department
- Participate in corporate initiatives and actions that ensure the continued success of the company
- Handles complicated or non-standard sources of data
What we are searching for:
- BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role
- 4-6 years of experience in SAS programming within the area of clinical trials.
- Prior experience using computerized information systems preferred.
- Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
- Demonstrated working knowledge of data processing, database design and organization in clinical data environment
- Demonstrated working knowledge of basic clinical trial design and analysis principles
- Working knowledge of CDISC standards and application of these standards to projects
- Working knowledge and understanding of advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Director, Biostatistical Programming
Description
Premier Research is looking for a Director, Biostatistical Programming to join our Biostatistics team! You will help biotech, MedTech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
The Director, Biostatistical Programming serves as core team member and leader for larger projects. This position is responsible for Biostatistical Programming operations, directing project assignments, and the overall activities of project team personnel. The Director also reviews departmental deliverables for accuracy, completeness, and compliance with project specifications to ensure quality deliverables to Sponsors. The Director is responsible for both management and technical aspects of development projects. As a technical expert, this individual provides strategic guidance to development projects. When functioning in a supervisory role, the Director provides coaching guidance to more junior staff and line management to the team, while overseeing the technical evolution of the departmental work product.
What you will be doing:
- Supervises, mentors, and motivates reporting associates in tasks and activities to develop and maintain the team structure.
- Provides support for the maintenance and management of the biostatistics macro library.
- Prepares specifications for CDISC and other analysis data sets.
- Performs QC (source code review, double-programming and log review) of SAS programs.
- Participates in and contributes to the training and development of new Biostatistical Programmers
- Lead efforts in the development, maintenance and adherence to departmental SOPs and guidelines
- Keeps up on CDISC and other industry standards and ensures dept is kept up to date.
- Integrates operational practices within the department across all offices/regions.
- Develops SAS programs to generate tables and listings without shells.
- Develops SAS programs to generate listings, tables and graphs as outlined by TLF shells.
- Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team.
What are we looking for:
- BS or equivalent from accredited college or university, in statistics, IT, mathematics or equivalent experience with programming in a scientific field. Equivalent combination of education, training and experience will be considered.
- 9+ years’ experience in SAS programming within the area of clinical trials.
- 7+ years’ experience as supervisor/manager.
- Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques..
· Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility, and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
See more jobs at Premier Research