Associate Director, Biostatistics Consultant - Oncology ( in Western EU

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….

Clin Choice is searching for a Associate Director, Biostatistics Consultant – Oncology to join one of our clients.

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.

• 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…