Vice President, Biostatistics

Key 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.
• 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

• PhD or Master’s degree in Biostatistics, Statistics, or related field.
• 10+ years of relevant experience in biotech/pharmaceutical R&D, including leadership of statistical strategy for early and late-stage clinical programs.
• Leadership & Strategic Impact: 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.
• Prominent 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.