- Provide strategic statistical leadership across development programs.
- Select suitable superiority, non-inferiority, or equivalence trial types based on regulatory and payer needs.
- Define and validate primary and secondary endpoints, including oncology endpoints.
- Design adaptive trials, including seamless Phase II/III, group sequential, and biomarker-driven basket or umbrella trials.
- Calculate sample size and power, including for patient subgroups.
- Establish proof-of-concept criteria, go/no-go decision gates, and futility stopping rules.
- Prepare and review data packages and attend health authority meetings to defend trial designs, endpoints, and statistical analysis plans.
- Anticipate and address regulatory concerns involving missing data, multiplicity adjustments, and bias.
- Use historical benchmark data and simulation models to estimate probability of technical success.
- Support pipeline prioritization with risk models and collaborate with commercial and portfolio management teams.