IQVIA
Job Level: FSP Principal Biostatistician, Study Powering and Design
Location: Home-based in the U.S. or Canada
Why DSSS?
Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields all the benefits of working for an industry leading global CRO and collaborating directly with cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.
Job Summary:
The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients.
Additional Benefits:
Job Responsibilities:
Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
Perform samples size and power calculations for optimizing study design
Author statistical analysis plans.
Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
Author or review analysis dataset and TLF specifications
Validation programming of efficacy analysis datasets plus tables, listings, and figures (TLF)
Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures for safety, etc.
Interpret study results and review reports of study results for accuracy.
Support exploratory analyses.
Participate in IND or NDA activities.
Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, SCE (Summary of Clinical Efficacy), SCS (Summary of clinical Safety).
Qualifications (Required)
Desired Experience:
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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $115,900.00 - $243,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.