Hybrid role (local candidates preferred): work out of the San Francisco, CA or North Chicago, IL office.
The Manager, Statistics provides statistical expertise to support R&D (clinical trials, patient safety, global medical affairs), working independently with cross-functional experts.
Responsibilities:
- Design, analyze, and report clinical trials/other studies; develop protocols and statistical analysis plans (incl. safety analysis plans) with programming details.
- Identify data collection instruments; report data issues/assumption violations; specify derived variables and analysis datasets; partner with Data Science for database lock.
- Perform analyses per plan; partner with Statistical Programming for high-quality outputs on timelines; anticipate study issues and propose sound approaches; assess software needs and potential novel methodology.
- Create strategy for data presentation and inference; support publications; ensure accuracy and consistency of tables/listings/figures and conclusions.
- Collaborate with multifunction teams; explain statistical concepts to non-statisticians; support analyses suggested by data.
Minimum Qualifications:
- MS (6+ years) or PhD (2+ years) in Statistics/Biostatistics (or related).
- Experience with statistical computations and simulations.
- Pharmaceutical/regulated drug development lifecycle knowledge desired.
Preferred:
- Oncology experience.
Other Required Skills:
- Strong oral/written communication; identify analytical/data issues and drive solutions; build cross-functional relationships; motivated to innovate.
Benefits (as stated): paid time off (vacation/holidays/sick), medical/dental/vision, and 401(k) for eligible employees; eligible for short- and long-term incentive programs.