Associate Director, Biostatistics Consultant – Oncology

Position Summary:

• Provide strategic statistical leadership across oncology drug development and clinical trial strategy.
• Work closely with Clinical Development, Regulatory, Medical, Commercial, and Portfolio teams.

Key Responsibilities:

• Select trial types (superiority, non-inferiority, equivalence) and define robust primary/secondary endpoints.
• Design adaptive trials and perform sample size/power calculations to balance risk and resources.
• Establish go/no-go decision gates and futility stopping rules to avoid sunk costs.

Regulatory and Portfolio Strategy:

• Prepare and review data packages and defend trial designs in meetings with health authorities like FDA or EMA.
• Use historical benchmark data and simulations to estimate Probability of Technical Success for pipeline prioritization.

Qualifications:

• Master's or Ph.D. in Statistics, Biostatistics, or related quantitative discipline.
• Significant pharmaceutical, biotech, or CRO experience with strong oncology focus.