Biostatistics & Strategy Senior Director

BioSpace; Malvern (Chester County); On-site; USD 210,000 - 320,000; Full time

Job summary

Ocugen seeks a Senior Director, Head of Biostatistics to lead statistical strategy for all clinical development programs from Malvern, PA. You will be accountable for design, integrity and delivery of statistical outputs and regulatory‑ready insights guiding development strategy and regulatory interactions.

You will build a scalable biometrics capability, partner with Clinical Development and Regulatory teams, and drive CRO/vendor performance while maintaining inspection readiness.

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).
• Deep experience in rare disease and/or gene therapy preferred.
• Experience operating in a lean, outsourced model with high accountability for vendors.
• Demonstrated ability to influence clinical and regulatory strategy through data.

Responsibilities

• Own and define the statistical strategy across all programs, ensuring alignment with clinical, regulatory, and corporate objectives.
• Serve as the single point of accountability for all statistical methodologies, assumptions, and outputs used in decision‑making.
• Guide the organization on innovative statistical approaches for gene therapy and rare disease (small populations, adaptive designs, etc.).
• Influence development strategy through data‑driven insights and risk framing.
• Establish and lead the Biostatistics function as a standalone capability, including operating model, standards, and talent strategy.
• Define how Biostatistics interfaces with Data Management, Programming, Clinical, and Regulatory.

Skills

Biostatistics leadership

Regulatory submissions

Statistical strategy

Cross-functional collaboration

Education

Ph.D. in Biostatistics

M.S. in Biostatistics

Job description

Ocugen seeks a Senior Director, Head of Biostatistics to lead statistical strategy for all clinical development programs from Malvern, PA. You will be accountable for design, integrity and delivery of statistical outputs and regulatory‑ready insights guiding development strategy and regulatory interactions.

You will build a scalable biometrics capability, partner with Clinical Development and Regulatory teams, and drive CRO/vendor performance while maintaining inspection readiness.