Job DescriptionAbout this Role
The Senior Principal Biostatistician is responsible for providing the statistical expertise for company products within one or more therapeutic areas, You will participate in protocol development, analysis plans and file/report specifications, and review study setup activities including but not limited to randomization, CRFs and data edits and serve as lead biostatistician for assigned project(s). You will perform statistical analyses, interpret statistical results, and prepare clinical study reports including integrated summaries for submissions as appropriate. You will also contributes to the long-term growth strategy of the department by participating in process improvement initiatives, keeping abreast of the current statistical methodology development, and providing mentorship to new/junior biostatisticians.What you'll do
- Represent Biostatistics on Project Teams; provides statistical expertise to support clinical development objectives and strategy
- Define statistical methodology, analyzes data and reports results and contributes to the strategic planning and execution of the clinical development plan for the assigned project; trains and supervises contract statisticians and ensures the quality of their deliverables.
- Assist responses to addressing statistical issues are part of regulatory, legal or other challenges to the company's products or processes; may represent Biostatistics in key meetings as assigned
- Serve as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel, and acts as an internal consultant, as assigned, on broad statistical issues that impact on the pharmaceutical/Biotechnology industry
- Participate in approved process improvement initiatives; mentors new/junior biostatisticians; keeps up to date current on statistical methodology and computing development. Conducts modelling and simulations as needed
Additional InformationWhy Biogen?
- 3+ years experience with PhD in Biostatistics/Statistics or MS in Biostatistics/Statistics with 5+ years experience
- Past regulatory interactions preferred
- Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.
- Ability to develop innovative/creative statistical/technical solutions to complex problems.
- Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.
- Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas.
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.