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Senior Director of Biostatistics
Job in
San Diego, San Diego County, California, 92189, USA
Listed on 2026-05-30
Listing for:
EPM Scientific
Full Time
position Listed on 2026-05-30
Job specializations:
-
IT/Tech
Data Security -
Research/Development
Job Description & How to Apply Below
Role Summary
We're partnered with a rare disease biotech seeking a Senior Director of Biostatistics to lead statistical strategy across clinical programs. This role will drive study design, ensure regulatory rigor, and partner cross‑functionally to advance therapies for high unmet need populations.
Key Responsibilities- Lead biostatistics strategy across early‑ and late‑phase rare disease studies
- Design trials for small populations (adaptive designs, Bayesian methods, external controls)
- Oversee statistical deliverables for regulatory submissions (protocols, SAPs, CSRs)
- Partner with Clinical, Regulatory, Data, and Ops teams to ensure quality and alignment
- Guide endpoint strategy, natural history data use, and patient‑focused trial design
- Manage internal teams and vendors
- Support FDA/EMA interactions and maintain ICH E9/CDISC standards
- PhD in Biostatistics or related field
- 12+ years in biostatistics, including rare disease or small population studies
- Proven leadership and regulatory submission experience (IND/NDA/BLA)
- Strong clinical trial design expertise in complex settings
- Experience with natural history or real‑world data preferred
- Proficiency in SAS, R, or similar tools
Position Requirements
10+ Years
work experience
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