Oncology Biostatistics Director – Strategic Trials Leader

Remote; San Francisco (CA); À distance; USD 180 000 - 300 000; Plein temps

Résumé du poste

ClinChoice is seeking an Associate Director, Biostatistics Consultant – Oncology to provide strategic statistical leadership across development programs, partnering with Clinical Development, Regulatory, Medical, and Portfolio teams. You will guide trial design choices, endpoints, and go/no-go decisions to optimize regulatory success and patient outcomes.

The role emphasizes oncology expertise, advanced trial design, and collaboration with cross-functional teams to drive development strategies

Qualifications

• Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative discipline.
• Significant experience in pharmaceutical, biotechnology, or CRO environments with strong oncology experience.
• Demonstrated experience in strategic drug development and clinical trial design, beyond traditional study-level responsibilities.
• Strong knowledge of oncology endpoints, adaptive designs, sample size/power, simulations, and statistical methodology.
• Experience supporting regulatory submissions and health authority interactions.
• Excellent communication and leadership skills with the ability to influence senior cross-functional stakeholders.

Responsabilités

• Decide trial type (superiority, non-inferiority, or equivalence) based on regulators and payers.
• Define and validate primary and secondary endpoints to ensure clinical meaningfulness and robustness.
• Design adaptive trials (seamless Phase II/III, group sequential, biomarker-driven baskets) to save time and patients.
• Perform sample size and power calculations to ensure efficient study design.
• Balance risk and resources with appropriate power to detect true effects while minimizing patient exposure.
• Assess powering for subgroup analyses (biomarker-positive, specific age groups).
• Establish Go/No-Go decision gates for progression.
• Define proof-of-concept criteria for Phase II and decide progression.
• Incorporate futility stopping rules into trial protocols.
• Engage in regulatory strategy and health authority negotiations to defend designs and SAPs.
• Mitigate regulatory risk by addressing objections and multiplicity concerns.
• Collaborate with commercial and portfolio teams to align statistical strategies with business goals.
• Quantify uncertainty using historical benchmarks and simulations to estimate PoS for assets.

Connaissances

Statistics

Biostatistics

Oncology experience

Clinical trial design

Regulatory submissions

Leadership

Formation

Master's or Ph.D. in Statistics/Biostatistics

Description du poste

ClinChoice is seeking an Associate Director, Biostatistics Consultant – Oncology to provide strategic statistical leadership across development programs, partnering with Clinical Development, Regulatory, Medical, and Portfolio teams. You will guide trial design choices, endpoints, and go/no-go decisions to optimize regulatory success and patient outcomes.

The role emphasizes oncology expertise, advanced trial design, and collaboration with cross-functional teams to drive development strategies