Associate Director, Biostatistics Consultant – Oncology - (Remote in UK- Outside IR35)

Job description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Associate Director, Biostatistics Consultant – Oncology to join one of our clients. Position Summary We are seeking an experienced Associate Director, Biostatistics with strong expertise in oncology drug development and clinical trial strategy . The individual will provide strategic statistical leadership across development programs and work closely with Clinical Development, Regulatory, Medical, Commercial, and Portfolio teams. The ideal candidate should have experience in: Selecting Trial Types: decide if a trial should be superiority, non-inferiority, or equivalence-based depending on what regulators and payers need to prove the drug beats a placebo or standard of care. Endpoint Selection: define and validate primary and secondary endpoints (e.g., overall survival, biomarker response rates, quality-of-life scores) to ensure they are measurable, clinically meaningful, and statistically robust. Innovative Designs: statisticians frequently design adaptive trials (e.g., seamless Phase II/III designs, group sequential designs, or biomarker-driven basket/umbrella trials) to save time and patients. Sample Size & Power Calculations Balancing Risk and Resources: use power calculations to ensure a trial has a high probability of detecting a true clinical effect without enrolling excess patients, which drives up costs and exposes unnecessary individuals to experimental risks. Subgroup Powering: They determine if the study is large enough to analyze specific patient subsets (e.g., biomarker-positive patients or specific age groups). Establishing Go/No-Go Decision Gates Proof-of-Concept Criteria: establish quantitative thresholds for Phase II trials (e.g., "If the hazard ratio is below 0.70 with a p-value , we proceed to Phase III"). Futility Stopping Rules: Experience in build rules into trial protocols to stop a failing trial early, preventing sunk costs on a drug that is unlikely to succeed. Regulatory Strategy and Health Authority Negotiations : experience in preparing and reviewing data packages and attending meetings with regulatory bodies (like the FDA or EMA) to defend trial designs, proposed endpoints, and statistical analys…