VP Biometrics- Cell Therapy
Vice President, Biostatistics - Cell Therapy
Location: U.S.-based (remote or hybrid; Northeast preferred)
Overview
A rapidly growing, clinical-stage biotechnology organization is seeking a Vice President, Biostatistics to serve as a key enterprise leader responsible for shaping the strategic direction, vision, and execution of its biometrics functions.
This individual will act as the principal statistical authority across the organization, partnering closely with executive leadership to guide clinical development strategy, influence portfolio decisions, and ensure statistical rigor from early-stage development through registration.
The role requires a balance of deep scientific expertise, strong strategic judgment, and operational leadership, with the ability to thrive in a dynamic, high-growth environment.
Key Responsibilities
Strategic Leadership & Vision
- 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
Clinical Development & Statistical Excellence
- 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
Regulatory & External Leadership
- 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
Cross-Functional Partnership
- 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
Organizational Build & Operational Excellence
- 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
Education & Experience
- 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
Leadership & Impact
- 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
Technical & Regulatory Expertise
- Deep understanding of global regulatory expectations, data standards, and inspection readiness
- Expertise in statistical methods across early and late-stage clinical development
Professional Profile
- 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
Why This Opportunity
- Enterprise-level impact across a growing clinical pipeline
- High visibility with executive leadership and external stakeholders
- Opportunity to build and shape a best-in-class biometrics function from the ground up
- Dynamic environment where scientific innovation and speed are critical differentiators