Executive Director, Biostatistics

Role Summary

Lead the biostatistics function across the entire portfolio within R&D, shaping global development programs and influencing regulatory strategy at the organizational level. Report to the VP and Head of Development and build and expand the internal biostatistics team, while partnering with Clinical, Regulatory, and Translational Sciences.

Responsibilities

• Serve as the companys statistical authority and leader, accountable for statistical strategy, oversight, and execution across the full clinical development lifecycle
• Provide immediate leadership for a high priority newly acquired Phase 3 asset, including study design, data strategy, and statistical oversight
• Drive statistical leadership for all key programs, including IND-enabling work, multiple phase 2/3 trials, global regulatory submissions, and post-marketing requirements
• Partner with clinical development leadership on clinical strategy, program risk assessment, and decision making at the highest levels
• Lead the design, statistical modeling, and analysis planning for clinical trials with appropriate balance of innovation and regulatory rigor
• Oversee and/or author development of key statistical documents, including Statistical Analysis Plans (SAPs), protocols, and regulatory components of global regulatory submissions
• Oversee internal biostatistical resources and lead strategic outsourcing to ensure scalable support for a growing portfolio
• Recruit, develop, and mentor a fit-for-purpose internal team, while effectively managing partnerships with CROs and statistical consultants
• Lead interactions with global regulatory authorities from a statistical perspective, including preparing for and participating in agency meetings (FDA, EMA, PDMA)
• Anticipate and respond to statistical challenges in BD evaluations, portfolio expansion, and evolving regulatory guidance
• Represent Biostatistics in governance forums, development leadership meetings and cross-functional initiatives

Qualifications

• Ph.D. required. Biostatistics, Statistics discipline preferred
• Minimum 15 years of experience in clinical biostatistics within biotech or pharma, including significant leadership in submissions, pivotal trials, and global regulatory interactions required
• Demonstrated experience providing statistical leadership at the portfolio level across multiple therapeutic areas, preferably including gastroenterology, immunology, dermatology, or neuroscience
• Strong record of contributions to global regulatory submissions (INDs, NDAs, BLAs), including responsibility for briefing books, response documents, and participation in meetings with health authorities (FDA, EMA)
• Highly proficient in modern statistical methodologies and tools; hands-on ability when needed in a lean environment
• Proven success in building and scaling statistical capabilities within high-growth or resource-constrained settings
• Exceptional communication and collaboration skills, capable of influencing senior stakeholders, leading matrixed teams, and navigating ambiguity
• Experience in business development assessments and integration of statistical thinking into asset evaluations is a plus
• Deep understanding of the role of biostatistics in shaping global clinical and regulatory strategy, not just execution
• Thrive in a matrix and lean organization and comfort working across multiple stakeholders and geographies

Education

• Ph.D. required. Biostatistics, Statistics discipline preferred