Associate Director of Biostatisticians
Ref #: 42
Location: N. California
Sector: Life Sciences
- Key player in the strategic planning and execution of the clinical development plan for the assigned project; provides strategic contributions to the clinical studies in the program, including study designs, protocol development, statistical analysis plans, data analysis and reporting, as well as key contributions to the planning and delivery of clinical components of regulatory submissions including INDs, BLAs, NDAs and MAAs.
- Provides key strategic contributions in addressing and statistical issues from regulatory, legal, or other challenges to the company's products or processes and represents the biostatistics of the company in key regulatory meetings or meetings with KOLs as required.
- Serves 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
- Participates 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 #LI-TG1
- PhD in Biostatistics/Statistics or equivalent with a minimum of 6-7 years relevant work experience or MS in Biostatistics/Statistics with a minimum of 8-9 years relevant experience
- Substantial past regulatory interactions
- 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.
- Strong verbal and written communication skills.
- Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership.