Senior Director Head of Biostatistics

Ocugen; Malvern (Chester County); On-site; USD 300,000 - 460,000; Full time

Job summary

Ocugen in Malvern, PA seeks a Senior Director, Head of Biostatistics to lead statistical strategy and outputs across clinical development programs, ensuring regulatory-ready insights. This role elevates Biostatistics as a core decision‑making engine and aligns statistics with regulatory expectations for gene therapy and rare disease programs.

The Head of Biostatistics will own study design, endpoints, interim analyses, and the preparation of CDISC datasets and integrated summaries, partnering

Qualifications

• Ph.D. or M.S. in Biostatistics, Statistics, or related field required.
• 12+ years of biometrics experience in clinical development.
• Experience leading statistical strategy through regulatory submissions (IND, BLA/NDA).
• Deep experience in rare disease or gene therapy preferred.
• Experience in lean outsourced models with high vendor accountability.

Responsibilities

• Own and define the statistical strategy across all programs, ensuring alignment with clinical, regulatory, and corporate objectives.
• Lead the Biostatistics function and interface with Data Management, Programming, Clinical, and Regulatory.
• Lead 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.
• Deliver SAPs, TLFs, CDISC-compliant datasets, and integrated summaries.
• Act as core member of program leadership and drive CRO/vendor performance.
• Translate complex statistical outputs into executive-level insights.

Skills

Leadership

Strategic thinking

Regulatory collaboration

Executive communication

Education

Ph.D. or M.S. in Biostatistics, Statistics, or related field

Job description

Position Summary

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.

Position Summary

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.

Responsibilities

Enterprise Statistical Leadership

• 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

Department Leadership & Capability Build

• 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
• Regulatory & Submission Leadership (Elevated)
• 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
• Program‑Level Accountability
• 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
• Operational Excellence
• 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
• Cross‑Functional Leadership
• 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

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

Attributes

• 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

Working Conditions

Incumbent will primarily work Monday – Friday during normal business hours out of our Malvern, PA corporate headquarters. This position operates in an office setting and Job may require incumbent to be available outside of normal hours to handle priority business needs. We do not offer remote work for this role.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.