Director, Biostatistics

Overview / About us The Director, Biostatistics will establish and lead PRO/COA statistical methodology within the Psychometrics and Statistics team, largely from the ground up, with significant latitude to define how the work gets done. This person holds deep, cross-jurisdictional expertise in how the EU Joint Clinical Assessment (JCA) under Regulation 2021/2282, alongside key national and US regulatory bodies, evaluate PRO/COA endpoints, and understands how these requirements diverge by country. The role is hands-on by design: this person will personally execute complex PRO/COA analyses (JCA analyses, related PRO analyses, and post-hoc PRO analyses of US trials), build reusable R-based tooling to scale the work, and construct the compliance- and audit-ready processes the function will run on. They will manage Biostatisticians directly. While the primary mandate is building the internal capability, the Director, Biostatistics will play an active role in scoping, pricing and selling the biostatistics work. Responsibilities / Position overview Technical Leadership & Execution — PRO/COA Statistical Methodology Personally leads and executes JCA analyses, related PRO analyses, and post-hoc PRO analyses of US trials. Leads PRO efficacy analyses, including MMRM, responder analyses, and Time to Deterioration (TTD). Applies multiple imputation methods to probe and address missingness in longitudinal PRO/COA data. Develops and derives/justifies Minimal Important Difference (MID) t