Key Responsibilities
- Provide technical leadership on multi-disciplinary/cross-functional projects.
- Lead assessment and introduction of new statistical technology/methodology.
- Develop clinical plans, innovative protocol designs, and statistical analysis plans with physicians/medical colleagues.
- Provide consulting and statistical direction on priority clinical projects.
- Collaborate to input on study protocol/design; write protocol and statistical analysis plan sections; perform analyses once database is created.
- Collaborate on planning/implementation of data quality assurance.
- Stay current on statistical methodology; justify selected methods; influence appropriate research methods.
- Perform peer-review of statistical work products.
- Collaborate to write reports and communicate results via regulatory submissions, manuscripts, oral presentations, and meetings; respond to regulatory queries.
- Understand disease states/competitive landscape/regulatory environment to enhance customer focus.
Basic Qualifications
- Ph.D. in Statistics or Biostatistics.
- 7+ yearsβ proven experience in clinical research and development.
Additional Skills/Preferences
- Significant experience with clinical trials, medical research, and/or real-world evidence.
- Working knowledge of experimental design and statistical analysis.
- Track record developing/maintaining statistical/collaborative research.
- Proficiency with SAS, R, Spotfire, WinBUGS, etc.
- Problem solving/critical thinking; teamwork/leadership; interpersonal communication; creativity/innovation.