Associate Director, Biostatistics Consultant – Oncology
C
ClinChoiceOncology drug development
Location: European UnionContractDirector
Salary not disclosed
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Job Details
Requirements
- Master’s or Ph.D. in Statistics, Biostatistics, or a related quantitative discipline.
- Significant experience in pharmaceutical, biotechnology, or CRO environments.
- Strong oncology experience.
- Demonstrated experience in strategic drug development and clinical trial design beyond traditional study-level responsibilities.
- Strong knowledge of oncology endpoints and adaptive designs.
- Knowledge of sample size and power calculations, simulations, and statistical methodology.
- Experience supporting regulatory submissions and health authority interactions.
- Ability to communicate effectively and influence senior cross-functional stakeholders.
Responsibilities
- 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.
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