VP Biometrics- Cell Therapy

Key Responsibilities

• Define and lead the long-term vision, operating model, and organizational structure for Biostatistics and Data Management
• Serve as a trusted advisor to executive leadership on statistical strategy, risk, and data-driven portfolio decisions
• Influence clinical development strategies, including trial design, endpoint selection, and feasibility assessments
• Provide expert oversight across all clinical programs, ensuring robust statistical methodologies and innovative study designs
• Lead the development and execution of statistical analysis plans and data review strategies
• Ensure all outputs meet the highest standards of quality, reproducibility, and regulatory readiness
• Lead statistical strategy for global regulatory interactions and submissions, including BLA components, briefing documents, and agency responses
• Represent the organization in regulatory meetings and ensure alignment with evolving global guidelines
• Collaborate closely with Clinical Development, Clinical Operations, Regulatory, Medical Affairs, and other functions to drive integrated, data-driven decision-making
• Oversee external vendors, CROs, and data partners to ensure high-quality, compliant execution
• Recruit, develop, and scale a high-performing Biostatistics and Data Management organization
• Champion modern statistical computing, data infrastructure, and scalable systems
• Drive continuous improvement through adoption of emerging methodologies and best practices

Required Qualifications

• PhD or MS in Biostatistics, Statistics, or related discipline
• 15+ years of experience in biotech/pharmaceutical R&D, with leadership responsibility across clinical programs
• Significant experience supporting late-stage development and regulatory submissions (BLA experience strongly preferred)
• Strong preference for Cell Therapy expertise
• Proven track record leading Biostatistics teams and cross-functional initiatives
• Demonstrated ability to shape statistical strategy for pivotal clinical trials
• Strong experience influencing executive stakeholders and navigating complex, evolving environments
• Deep understanding of global regulatory expectations, data standards, and inspection readiness
• Expertise in statistical methods across early and late-stage clinical development
• Exceptional communication skills, with the ability to translate complex concepts into clear business insights
• Collaborative, strategic, and execution-oriented leader with strong interpersonal influence
• Comfortable operating in a fast-paced, high-growth environment with hands-on leadership responsibilities