Director/Senior Director, Biostatistics
$230,000–$300,000 year
Hybrid · San Francisco, California, United States
Job Summary
Director or Senior Director of Biostatistics to serve as the statistical lead across our autoimmune clinical pipeline. Own the statistical strategy for clinical programs—from designing strategy through data analysis, interpretation, and regulatory submission. Define and build the Biostatistics function as the portfolio grows; collaborate with clinical, regulatory, and translational teams to align endpoints and estimands with regulatory expectations; oversee CROs/biostatistics vendors; stay current with evolving guidance; contribute to CSRs and regulatory interactions; drive methodological rigor and cross-functional accountability across development stages.
Required Qualifications
- Ph.D. in Biostatistics, Statistics, or closely related quantitative discipline; MS with substantial industry experience also considered
- 10+ years of industry experience in clinical biostatistics (Director) or 15+ years (Sr. Director) with Phase 1–3 program responsibility
- Deep knowledge of ICH guidelines (E8, E9, E9(R1), E10, E17) and FDA/EMA statistics guidance
- Hands-on experience with SAS (required) and R (preferred) and CDISC standards (SDTM, ADaM)
- Experience with adaptive trial designs, Bayesian methods or other innovative designs
- Proven ability to author/defend statistical sections of regulatory submissions (SAPs, CSRs, integrated summaries)
- Experience in immunology, rheumatology, gastroenterology, or autoimmune/inflammatory diseases preferred
- Strong scientific communication skills; ability to present complex concepts to varied stakeholders
- Comfortable in a lean biotech environment with CROs and cross-functional accountability
- Pharmacovigilance or regulatory submission experience with CSRs and health authority interactions
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