Associate Director, Biostatistics Consultant – Oncology (Remote in Western EU)

ClinChoiceEuropean Union remoteSalary not postedView the original posting at ClinChoice ↗

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 analysis plans (SAPs). Mitigating Regulatory Risk: Experience in anticipating and addressing statistical objections from health authorities regarding missing data handling, multiplicity adjustments (controlling for false positives when looking at multiple endpoints), and bias. At the macro–Strategic Drug Development level, statisticians should have experience working with commercial and portfolio management teams . Quantifying Uncertainty: Experience in using historical benchmark data and simulation models to estimate the Probability of Technical Success (PoS) for an asset at each development phase. Pipeline Prioritization: Using risk models to help executive leadership in deciding whether to advance, partner, or kill an asset based on its statistical likelihood of clearing regulatory and market hurdles. 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. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requ

The people who work here are one introduction away.

We show you who they are and write your first message — the insider list for this posting is filling in now. You have one introduction. The rest follows.

People at ClinChoice you can reach out to

26 of 57 public LinkedIn profiles found in searches for ClinChoice list ClinChoice in their headline — those are the ones you can be confident work there. Pick who to reach out to — we'll draft your message; you make the contact. The rest, when shown, are marked Unverified.

Profiles are public pages as indexed by the search engine — we never log in to LinkedIn or copy private data, and anyone can ask to be removed. Ask to be removed →

Start the conversation More Biostatistics jobs

Remote Biostatistics jobs →Entry level Biostatistics jobs →Senior Biostatistics jobs →All ClinChoice jobs →