Sr. Director, Biostatistics & Statistical Programming

Responsibilities

• Strategic & Executive Leadership
• 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) across all programs.
• Serve as the primary statistical resource for Data Monitoring Committees (DMCs), interim analyses, executive-level data reviews, and governance committee presentations.
• Ensure statistical methodologies are scientifically defensible, clinically interpretable, and aligned with current FDA and EMA regulatory expectations for ophthalmic gene therapies.
• Lead statistical innovation efforts, including Bayesian adaptive designs, novel estimands (ICH E9 R1), natural history-informed analyses, and patient-level simulation approaches relevant to rare disease programs.
• Statistical Programming Leadership
• Provide strategic and hands-on operational oversight of all statistical programming activities.
• Establish and enforce programming standards, validation procedures, and quality control processes consistent with inspection readiness and global regulatory compliance.
• Direct oversight of CRO and statistical programming vendors, ensuring quality, timeliness, and regulatory defensibility of all deliverables.
• Champion implementation of automation, modern programming tools, and operational efficiencies to improve quality and execution speed across programs.
• Ensure all programming deliverables meet FDA and EMA eCTD submission requirements, including electronic Common Technical Document formatting standards.
• Clinical Data Review & Development Decision Support
• Partner closely with Clinical Development, Clinical Sciences, Medical Affairs, and Regulatory Affairs to interpret emerging clinical and biomarker data and inform program-level decisions.
• Lead integrated reviews of efficacy, safety, imaging, and functional assessments — including retinal imaging (OCT, fundus), electrophysiology (ERG/mfERG), and visual function measures specific to inherited retinal diseases.
• Present data analyses and strategic biometrics recommendations to C-suite leadership, Board of Directors, and external governance bodies.
• Serve as an internal expert on the natural history of inherited retinal disease and gene therapy endpoints, providing scientific context for statistical interpretations.
• Operational Excellence & Team Development
• Build and develop Ocugen’s internal biometrics function, including hiring, mentorship, and performance development of biostatistics and programming staff.
• Drive accountability for external vendors and CRO partners; establish governance structures for vendor oversight and issue escalation.
• Implement scalable, milestone-driven processes supporting current late-stage programs and future pipeline growth.
• Maintain the highest standards of data integrity, quality, and regulatory defensibility across all programs.
• Ensure perpetual inspection readiness in compliance with FDA 21 CFR Part 11, GCP, and global expectations for advanced therapy submissions.

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.
• Demonstrated success leading biometrics activities supporting late-stage clinical development and regulatory submissions — including at least one BLA or NDA filing with FDA or equivalent global submission — with a strong record of successful health authority interactions.
• Deep expertise in ophthalmology clinical development, including ophthalmic endpoints (BCVA, LLVA, FSST, microperimetry, EZ integrity on OCT), retinal imaging assessments, central reading center oversight, and ophthalmology-specific regulatory submission strategies.
• Experience supporting gene therapy clinical development programs, preferably AAV-based or other viral vector platforms.
• Expert-level knowledge of GCP, ICH E9/E9(R1), ICH E6, CDISC standards (SDTM, ADaM, DEFINE-XML), and FDA/EMA regulatory expectations for advanced therapies.
• Demonstrated experience overseeing external statistical programming vendors and CROs in a late-stage, submission-critical environment.
• Exceptional leadership, scientific communication, and cross-functional influencing skills; proven ability to operate effectively in a lean, agile biotechnology environment.