Director, Biostatistics

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.

• 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) thresholds to support responder analyses.
• Applies estimand framework principles and intercurrent event handling consistent with ICH E9(R1).
• Builds this functional capability within the Psychometrics and Statistics team, largely defining scope, standards, and approach directly.

• Designs and implements workflows and documentation practices that are compliance‑ and audit‑ready, aligned to applicable standards (e.g., JCA Appendix
  
  D.3 evidence‑synthesis requirements).
• Establishes standardized templates and QC practices to enable consistent delivery as the function grows, largely built from scratch, with latitude to define the approach.

• Programs in R (expert‑level proficiency required).
• Applies functional programming principles to build R‑based tools that make analytical tasks repeatable and scalable.
• Owns the design of these tools end to end, this is a build‑it‑yourself mandate, not an inherited toolkit.

• Maintains current, working knowledge of the regulatory and methodological landscape governing PRO/COA evidence across major jurisdictions, including but not limited to:
• EU HTA Regulation (EU) 2021/2282: The core legal framework governing the mandatory rollout of Joint Clinical Assessments (JCAs), beginning with oncology and ATMPs in 2025 and expanding over time — including HTA Coordination Group (HTACG) methodological guidance on how clinical endpoints (HRQoL, PROs) must be presented relative to defined Population-Intervention-Comparator-Outcomes (PICOs).
• National HTA bodies (Europe): Historical national standards that continue to influence JCA scrutiny, particularly on open‑label bias and missing PRO data, notably Germany (IQWiG/G‑BA), France (HAS), and the UK (NICE Evidence Standards Framework / DSU Technical Support Documents).
• EMA: Reflection papers and guidelines on the use of PRO measures in oncology and other therapeutic areas.
• FDA: Relevant statistical and PRO/COA guidance — for example, principles on adjusting for covariates in randomized clinical trials and baseline‑adjustment approaches in mixed models — among other applicable FDA guidances.
• ICH: E9 and E9(R1) framework, particularly as applied to estimands and…