Vice President, Biostatistics

Responsibilities

• Define and execute the biostatistics strategy, setting clear goals aligned with oncology clinical development objectives.
• Provide statistical leadership in the design and execution of clinical trials across all stages of development, including registrational strategies.
• Build a high-performing team and establish processes, SOPs, and governance frameworks to ensure efficiency, standardization, and compliance across the portfolio.
• Drive innovation in statistical methods and analytics to improve decision-making and execution speed.
• Lead the design and review of clinical protocols, including statistical considerations, sample size calculations, interim analyses, randomization approaches, and study design recommendations.
• Ensure biostatistics activities support regulatory readiness, including adherence to CDISC and other regulatory standards.
• Serve as a core representative in cross-functional meetings, aligning biostatistics strategy with clinical development, regulatory affairs, and quality assurance.
• Lead interactions with health authorities (e.g., FDA, EMA, PMDA) to address statistical questions during regulatory reviews.
• Oversee CRO and vendor strategy, including vendor selection, relationship management, performance oversight, and cost optimization.
• Establish and maintain strong partnerships with external vendors and service providers to support clinical development objectives and operational excellence. 
• Build, recruit, and retain a high-performing internal Biostatistics team; manage headcount planning in alignment with pipeline milestones.

Education & Experience

• Advanced degree (PhD preferred) in Biostatistics, Statistics, Data Science, or a related quantitative field.
• 15+ years of experience in clinical biostatistics, with significant experience in oncology drug development within biotech or biopharmaceutical companies.
• Demonstrated experience supporting clinical programs from IND through NDA/BLA submission and regulatory approval, including registrational trials.
• Prior experience leading or contributing to regulatory interactions and submissions with global health authorities, including FDA, NMPA, and EMA.
• Demonstrated leadership and people management experience with cross-functional teams.
• Familiarity with clinical data standards (e.g., CDISC SDTM/ADaM).
• Strong understanding of regulatory requirements and clinical development processes.

What We Offer

• Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
• Competitive compensation, including base salary, performance bonus, and equity
• 100% employer-paid benefits package
• Flexible PTO; also, two, one-week company-wide shutdowns each year
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities