Associate Director, Biostatistics Consultant – Oncology

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Deliver strategic statistical guidance across development initiatives

• Collaborate closely with Clinical Development, Regulatory, Medical, Commercial, and Portfolio teams

• Choose trial types based on superiority, non-inferiority, or equivalence

• Define and validate both primary and secondary endpoints in oncology

• Design adaptive trials, such as seamless Phase II/III, group sequential, basket, and umbrella trials

• Conduct calculations for sample size, power, and subgroup powering

• Set up go/no-go decision gates, proof-of-concept criteria, and futility stopping rules

• Prepare and review data packages and participate in health authority meetings to defend trial designs, endpoints, and statistical analysis plans

• Proactively identify and tackle regulatory challenges related to missing data, multiplicity adjustments, and bias

• Utilize historical benchmark data and simulation models to estimate the Probability of Technical Success

• Assist in making pipeline prioritization decisions regarding the advancement, partnering, or discontinuation of assets

⛳️ Requirements

• Master’s degree or Ph.D. in Statistics, Biostatistics, or a related quantitative field

• Extensive experience in pharmaceutical, biotechnology, or CRO settings with a strong focus on oncology

• Proven experience in strategic drug development and clinical trial design that surpasses traditional study-level responsibilities

• In-depth knowledge of oncology endpoints, adaptive designs, sample size/power, simulations, and statistical methodologies

• Experience in supporting regulatory submissions and engaging with health authorities

• Exceptional communication and leadership abilities with the capacity to influence senior cross-functional stakeholders

🏝️ Benefits

• Stability and additional career advancement opportunities within a global CRO

• Ongoing training and close management to develop and sustain highly-qualified personnel

• Equal opportunity employer dedicated to diversity and inclusivity