Senior Director Head of Biostatistics
On-siteMalvern, Pennsylvania, United States
Job Summary
Lead statistical strategy across all clinical development programs, defining methodologies, sample size, and endpoints while serving as the single point of accountability for regulatory submissions including INDs and BLAs. Establish the Biostatistics function as a standalone capability, setting standards, building talent, and managing vendor performance to ensure inspection readiness. Translate complex outputs into executive insights for development strategy, regulatory interactions, and board-level narratives. Operate Monday through Friday at Ocugen's Malvern, PA headquarters, balancing scientific rigor with lean biotech execution speed.
Required Qualifications
- Ph.D. or M.S. in Biostatistics, Statistics, or related field
- 12+ years of experience in biometrics, with demonstrated leadership in clinical development programs
- Proven experience leading statistical strategy through regulatory submissions (IND, BLA/NDA)
- Experience operating in a lean, outsourced model with high accountability for vendors
- Demonstrated ability to influence clinical and regulatory strategy through data
- Must be available outside of normal hours to handle priority business needs
- Must work out of Malvern, PA corporate headquarters
- No remote work
Desired Qualifications
- Deep experience in rare disease and/or gene therapy preferred
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