Associate Director, Biostatistics Consultant – Oncology - (Remote in UK- Outside IR35)
Core
Provide strategic statistical leadership for oncology drug development programs, defining trial designs, endpoints, and regulatory strategies.
Role type
Senior IC biostatistician (oncology)
Builds
Clinical trial protocols, statistical analysis plans (SAPs), and regulatory data packages for oncology assets.
Domain
Pharmaceutical/Biotechnology, Oncology
Required skills
Oncology drug development, Clinical trial strategy, Adaptive trial design, Sample size and power calculations, Regulatory strategy, Health authority negotiations, Simulation modeling, Pipeline prioritization, Go/No-Go decision criteria, Futility stopping rules
Preferred skills
Experience with FDA or EMA interactions, Knowledge of multiplicity adjustments, Experience with biomarker-driven basket/umbrella trials
Technologies
R, SAS, Python (implied by simulation/modeling context), Clinical trial software
Responsibilities
Select trial types (superiority, non-inferiority, equivalence), Define and validate primary/secondary endpoints, Design adaptive trials, Perform sample size and power calculations, Establish go/no-go decision gates and futility rules, Support regulatory submissions and health authority meetings, Quantify uncertainty using simulation models, Prioritize pipeline assets based on statistical likelihood of success
Seniority
Senior, hands-on IC