Director, Biostatistics

Lumanity; Greater London; On-site; GBP 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary

Bonus

Pension

Private Healthcare

Dental Cover

Enhanced Eye Care Cover

Electric Car Scheme

Staggered working hours

Job summary

Lumanity seeks a Director, Biostatistics to establish and lead PRO/COA statistical methods within the Psychometrics and Statistics team. You will own end-to-end PRO/COA analyses for trials and HTA submissions, building reusable R tools and compliant processes.

You will manage Biostatisticians, contribute to scoping and pricing of work, and engage in client discussions as a technical SME. The role requires deep regulatory knowledge across the EU, US, and UK frameworks.

Qualifications

• Ph.D. or Master’s in Biostatistics, Statistics, Quantitative Psychology/Psychometrics, or related field.
• 8+ years in biostatistics within life sciences consulting.
• Autonomy in delivering complex PRO/COA analyses.
• Deep PRO/COA methodology across lifecycle from trial design to HTA submission.
• Experience with missing data methods (MI, tipping point analyses, pattern mixture).
• Experience contributing to or overseeing JCA or multi-country HTA dossiers.
• Proficiency in R and functional programming to build reusable tools.
• People leadership experience managing biostatistics staff.
• Strong communication translating complex stats and regulatory nuance for stakeholders.

Responsibilities

• Lead PRO/COA statistical methodology and JCA analyses.
• Build scalable, R-based tooling and documentation.
• Manage day-to-day Biostatistics team activities and performance.
• Contribute to scoping, budgeting, and proposals for statistical workstreams.
• Represent the practice in client-facing capability discussions.

Skills

Biostatistics expert

PRO/COA methodology

R programming

HTA/regulatory knowledge

Team leadership

Business development

Communication skills

Education

Ph.D. or Master’s in Biostatistics/Statistics

Tools

R

Job description

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) 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.

Infrastructure, Process & Compliance Build‑Out

• 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.

Statistical Programming & Tooling

• 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.

Regulatory & HTA Guidance Expertise

• 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.

Team Management

• 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.

Business Development

• 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.

Qualifications

Required Education/Skills/Experience:

• 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.

Preferred Qualifications

• 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).

Benefits

• Competitive salary
• Bonus
• Pension
• Private Healthcare
• Dental Cover
• Enhanced Eye Care Cover
• Electric Car Scheme
• Staggered working hours