Associate Director, Biostatistics

Associate Director of Biostatistics

Responsibilities:
- Contribute to statistical design and analysis of early and late phase clinical studies.
- Use advanced statistical methods and data visualization for clinical trial summaries, including integrated safety/efficacy analyses for regulatory submissions.
- Serve as biostatistics representative on cross-functional teams.
- Provide input on study design, endpoint selection, and sample size planning.
- Draft statistical analysis plans (SAPs) and support interpretation of results.
- Ensure quality/accuracy of statistical deliverables by independently generating and/or validating deliverables from CROs or internal teams.
- Manage CROs and mentor junior staff/contractors.

Qualifications:
- Ph.D. in Biostatistics with 6+ years industry experience, or Master’s with 8+ years.
- Study statistician experience on global Phase III trials (preferably immunology/immune-mediated).
- Experience supporting regulatory submissions (NDA/BLA/MAA), including integrated safety/efficacy analyses.
- Hands-on experience in a biotechnology/pharmaceutical sponsor setting.
- Proven ability to manage CROs and statistical programming teams.
- Strong clinical trial design, statistical analysis, and regulatory guideline knowledge.
- Proficiency in SAS and R.
- Publication work and/or real-world data experience preferred.

Skills:
- Strong analytical thinking and attention to detail.
- Excellent verbal/written communication.
- Ability to work independently in a fast-paced, regulated environment; manage competing priorities and influence effectively.

Compensation/Benefits (as stated):
- Salary range: $190,000–$230,000 USD annually.
- Health premiums: 90% employee / 80% dependents; $100 monthly cell phone stipend; Unlimited PTO (exempt); free onsite gym; free snacks/drinks; stock options; annual bonus program; Genentech Bus & Ferry Share access.

Location:
- South San Francisco, CA; onsite Tuesday–Thursday (remote PT may be considered case-by-case).