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

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.

Responsibilities

Provide strategic statistical leadership across development programs; work closely with Clinical Development, Regulatory, Medical, Commercial, and Portfolio teams

Requirements

Strong expertise in oncology drug development and clinical trial strategy; experience selecting superiority, non-inferiority, or equivalence trial types based on regulator and payer needs; endpoint selection and validation for primary and secondary endpoints such as overall survival, biomarker response rates, and quality-of-life scores; designing adaptive trials such as seamless Phase II/III, group sequential, or biomarker-driven basket/umbrella trials; sample size and power calculations; balancing risk and resources through power calculations; subgroup powering for specific patient subsets; establishing Go/No-Go decision gates; proof-of-concept criteria with quantitative thresholds for Phase II trials; futility stopping rules; regulatory strategy and health authority negotiations including preparing and reviewing data packages and attending meetings with FDA or EMA; mitigating regulatory risk related to missing data handling, multiplicity adjustments, and bias; experience working with commercial and portfolio management teams; quantifying uncertainty using historical benchmark data and simulation models to estimate Probability of Technical Success; pipeline prioritization using risk models to support decisions to advance, partner, or kill assets; 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

Benefits

Security and additional career opportunities that working for a global CRO can bring