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 intercurrent events in PRO/COA analysis.

• Manages the day-to-day work of Biostatisticians, including performance management, technical coaching, and career development.
• Serves as the senior escalation point for methodologically complex or high-risk technical questions requiring senior-level statistical judgment.

• Contributes to scoping statistical work, translating client needs into accurate, deliverable-based scopes of work, timelines, and staffing plans.
• Develops level-of-effort estimates and budget inputs for statistical workstreams (e.g., multi-PICO JCA support) and contributes methodology sections to proposals and bid defenses.

Represents the practice in client-facing capability discussions, serving as a technical SME in during scoping and pitching

• Demonstrated business development experience (scoping, budgeting, proposal development, bid defenses), a plus, not a core requirement.
• Established presence in the field through publications, conference presentations (e.g., ISPOR), or comparable visibility in PCO or HTA methodology — nice to have, not expected as a deliverable of this role.
• Experience leveraging emerging AI tools to scale statistical programming, scientific writing, and quality review processes.
• Direct authorship or senior review experience on a submitted JCA dossier (Appendix D.3 evidence synthesis).
• Experience with additional country-level HTA systems beyond the US and EU (e.g., Canada CADTH/CDA-AMC, Australia PBAC).

• Ph.D. or Master's degree in Biostatistics, Statistics, Quantitative Psychology/Psychometrics, or a related quantitative discipline.
• 8+ years of progressive experience in biostatistics within life sciences consulting.
• Comfort operating with significant autonomy.
• Deep, hands-on expertise in PRO/COA statistical methodology across the full lifecycle from trial design through HTA submission, including MMRM, responder analyses, TTD, estimand framework application, and intercurrent event handling.
• Demonstrated expertise in missing data methods (e.g., multiple imputation, tipping point analysis, and pattern mixture modeling) for longitudinal PRO/COA data.
• Direct experience contributing to or overseeing JCA or equivalent multi-country HTA dossiers, including evidence-synthesis documentation and programming (e.g., JCA Appendix D.3 standards).
• Proven expertise in HTA and regulatory expectations for PRO/COA evidence across the EU (JCA/Regulation 2021/2282), key national bodies (IQWiG/G-BA, HAS, NICE), EMA, and FDA, with practical understanding of how country-level differences affect analysis design.
• Expert-level proficiency in R, including functional programming to build reusable, scalable analytical tools from the ground up.
• Track record of building or scaling statistical processes, SOPs, or methods infrastructure, ideally having built something rather than only maintained it.
• People leadership experience, including managing and developing biostatistics staff.
• Strong communication skills, with the ability to translate complex statistical and regulatory nuance into clear guidance for both technical and non-technical stakeholders.

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