Senior Director Head of Biostatistics

OCUGEN OPCO INC•East Whiteland Township, PA

11d•Onsite

About The Position

The Senior Director, Head of Biostatistics is the enterprise leader accountable for the design, integrity, and delivery of all statistical strategy and outputs across Ocugen’s clinical development programs. This role goes beyond functional execution to establish Biostatistics as a core scientific and decision-making engine within the organization. The Head of Biostatistics ensures that all clinical data are translated into clear, defensible, and regulatory-ready insights that directly inform development strategy, regulatory interactions, and business decisions. As a key member of the Clinical Development leadership team, this individual owns the statistical strategy across programs, ensures alignment with regulatory expectations for gene therapy and rare disease development, and builds a scalable biometrics capability to support Ocugen’s progression toward multiple BLA submissions.

Requirements

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
Balances scientific rigor with execution urgency
Comfortable operating with ambiguity and incomplete data
Direct, transparent, and enterprise-minded
Able to translate complexity into clarity for leadership

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
Build a scalable, fit-for-purpose model leveraging internal leadership and external partners
Set clear expectations for accountability, quality, and delivery across all biometrics activities
Serve as the lead statistical voice in regulatory interactions, including FDA/EMA meetings and submission strategy
Ensure all statistical components of INDs, BLAs, and regulatory responses are defensible, consistent, and inspection-ready
Own the statistical narrative in submissions (not just outputs), including interpretation and positioning of results
Anticipate and proactively address regulatory risk related to data and analysis
Accountable for statistical design and execution across all trials, including: Study design and endpoints, Sample size and power considerations, Interim analysis and decision frameworks
Ensure delivery of: SAPs, TLFs, CDISC-compliant datasets, Integrated summaries
Act as a core member of program leadership, not a downstream function
Drive performance of CROs and vendors with clear ownership of outcomes, not oversight alone
Ensure biometrics execution aligns to milestone-driven timelines (IND, BLA, topline data)
Implement processes that balance: Speed (lean biotech reality), Rigor (regulatory expectations)
Ensure continuous inspection readiness
Partner with: Clinical Development (study design & execution), Regulatory (submission strategy & HA interactions), Program Leadership (timelines, risks, dependencies)
Translate complex statistical outputs into clear, executive-level insights
Contribute to board-level and investor-facing narratives where data interpretation is critical