Sr. Director, Biostatistics & Statistical Programming

Responsibilities

• Strategic & Executive Leadership
• Represent Ocugen as the senior biometrics lead in interactions with the FDA, EMA, and other global health authorities.
• Provide statistical leadership for gene therapy development programs.
• Contribute to R&D governance, portfolio prioritization, and executive-level strategic planning.
• Biostatistics Leadership — Late-Stage & Regulatory
• Lead statistical design, analysis planning, interpretation, and reporting for all late-stage clinical programs.
• Oversee development, review, and final approval of Statistical Analysis Plans (SAPs).
• Ensure statistical methodologies are scientifically defensible and aligned with regulatory expectations.
• Statistical Programming Leadership
• Provide strategic and hands-on operational oversight of all statistical programming activities.
• Direct oversight of CRO and statistical programming vendors.
• Operational Excellence & Team Development
• Build and develop Ocugen’s internal biometrics function.

Qualifications

• PhD or MS in Biostatistics, Statistics, Mathematics, or a related quantitative discipline; PhD strongly preferred.
• 15+ years of progressive experience in biostatistics and/or statistical programming in biopharmaceutical development, with at least 5 years in a senior leadership role.
• Deep expertise in ophthalmology clinical development, including ophthalmic endpoints, retinal imaging assessments, and regulatory submission strategies.
• Experience supporting rare inherited retinal disease (IRD) programs and natural history-informed trial design.
• Experience with Bayesian adaptive trial designs, estimand frameworks, and novel statistical methods applicable to small patient populations.