Director, PRO/COA Biostatistics & HTA Leadership (Hybrid)

Lumanity; England; On-site; GBP 120,000 - 160,000; 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 in the United Kingdom seeks a Director of Biostatistics to establish PRO/COA statistical methodology within the Psychometrics and Statistics team, with broad latitude to define the approach. The role is hands-on, executing JCA analyses, developing reusable R tooling, and shaping compliant processes.

The position requires deep regulatory knowledge across EU/US HTA bodies, expertise in missing data methods and estimand frameworks, and leadership of Biostatisticians to scale the function.

Qualifications

• Ph.D. or Master’s degree in Biostatistics, Statistics, Quantitative Psychology/Psychometrics, or 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.
• 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.

Responsibilities

• Lead PRO/COA analyses including JCA, PRO analyses, and post-hoc PRO analyses of US trials.
• Lead PRO efficacy analyses, including MMRM, responder analyses, and Time to Deterioration (TTD).
• Apply multiple imputation methods to address missingness in longitudinal PRO/COA data.
• Develop Minimal Important Difference thresholds to support responder analyses.
• Apply estimand framework principles and intercurrent event handling per ICH E9(R1).
• Build the internal capability by defining scope, standards, and approach for the Biostatistics team.
• Design and implement compliant workflows and templates aligned to HTA/evidence-synthesis standards.
• Own R-based tooling end-to-end to ensure repeatability and scalability.
• Manage day-to-day Biostatistician workload and provide coaching and development.
• Contribute to scoping, budgeting, and proposals for statistical workstreams, acting as SME in client discussions.

Skills

Autonomy

PRO/COA methods

R programming

Leadership

Regulatory communication

Education

Ph.D. in Biostatistics or related field

Master's in Biostatistics or related field

Tools

R (advanced)

Job description

Lumanity in the United Kingdom seeks a Director of Biostatistics to establish PRO/COA statistical methodology within the Psychometrics and Statistics team, with broad latitude to define the approach. The role is hands-on, executing JCA analyses, developing reusable R tooling, and shaping compliant processes.

The position requires deep regulatory knowledge across EU/US HTA bodies, expertise in missing data methods and estimand frameworks, and leadership of Biostatisticians to scale the function.