Vice President, Biostatistics

Role Summary

The Vice President, Biostatistics is a senior enterprise leader responsible for setting the strategic direction and execution of the company’s biostatistics and data management capabilities. Reporting to the VP, Clinical Development, this role serves as the principal statistical authority across the organization, guiding program strategy and portfolio decisions from early development through registration. Location options: Philadelphia, PA headquarters with hybrid, or remote (strong preference for candidates based in the Northeast). The role balances scientific rigor with operational pragmatism and leads cross-functional teams to build organizational capability.

Responsibilities

• Lead and develop the Biostatistics and Data Management functions, developing a long-term vision, operating model, and high-performance culture.
• Recruit, mentor, and inspire the team to ensure organizational capability scales with the company’s clinical portfolio.
• Serve as a strategic advisor to executive leadership on statistical risk, trial feasibility, portfolio trade-offs, and data-driven decision making.
• Provide expert statistical input into clinical development strategy, protocol concepts, study design, and endpoint selection to optimize probability of technical and regulatory success.
• Drive innovative statistical approaches, adaptive designs, and data-driven methodologies to accelerate development timelines and enhance the robustness of clinical findings.
• Ensure all statistical strategies align with regulatory expectations and meet the needs of future submissions, inspections, and commercial planning.
• Oversee development and execution of statistical analysis plans, data review strategies, and inferential methodologies for all clinical studies.
• Ensure the integrity, quality, reproducibility, and validation of statistical analyses, including submission-ready documentation.
• Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and other teams to ensure seamless execution and data-driven decision making.
• Provide statistical leadership for regulatory interactions and submissions, including authoring and reviewing statistical components of BLAs, briefing packages, responses, and advisory committee materials; late-stage development experience is strongly preferred.
• Represent the company in regulatory meetings as needed and ensure alignment with global regulatory standards and evolving guidance.
• Oversee CROs, data vendors, and technology platforms to ensure high-quality deliverables, on-time execution, and compliance with regulatory and industry standards.
• Champion modern data management and statistical computing practices, ensuring infrastructure supports scale, audit readiness, and efficiency.
• Stay abreast of emerging statistical methodologies, regulatory trends, and industry best practices to ensure the organization remains at the forefront of scientific and statistical innovation.

Qualifications

• 10+ years of relevant experience in biotech/pharmaceutical R&D, including leadership of statistical strategy for early and late-stage clinical programs.
• At least 7 years leading Biostatistics teams, including management of statisticians, programmers, and/or data management groups.
• Demonstrated success in shaping statistical strategy for pivotal trials and regulatory submissions.
• Proven ability to influence senior stakeholders, navigate ambiguity, and drive alignment across cross-functional teams.
• Strong track record of contributing to late-stage development/regulatory submissions with BLA experience strongly preferred.
• Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness.
• Exceptional communication skills with ability to translate complex statistical concepts into clear, actionable insights for diverse audiences.
• Experience managing departmental budgets, vendor relationships, and technical infrastructure.
• Highly collaborative, with strong interpersonal skills and the ability to build trust across teams.
• Strategic thinker with strong scientific rigor and operational pragmatism.
• Thrives in a fast-paced, evolving environment; able to manage multiple priorities with clarity and focus.
• Demonstrates integrity, accountability, and a commitment to continuous learning and team development.
• Comfortable with hands-on leadership in a small-company environment.

Education

• PhD or Master’s degree in Biostatistics, Statistics, or related field.