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Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in PRO/COA statistical methodology, including MMRM, responder analyses, and multiple imputation methods, is essential for leading statistical analyses and developing compliant workflows. Proven leadership in managing biostatistics teams and translating complex statistical concepts for diverse stakeholders is critical.
Highest-signal resume keywords
Ph.D. Or Master's Degree In Biostatistics8+ Years Of Experience In BiostatisticsExpert-Level Proficiency In RDeep Expertise In PRO/COA Statistical MethodologyPeople Leadership Experience
About the role
Key responsibilities & impact- Establish and lead PRO/COA statistical methodology within the Psychometrics and Statistics team
- Personally execute JCA analyses, related PRO analyses, and post-hoc PRO analyses of US trials
- Lead PRO efficacy analyses, including MMRM, responder analyses, and Time to Deterioration analyses
- Apply multiple imputation methods to address missingness in longitudinal PRO/COA data
- Develop and justify Minimal Important Difference thresholds for responder analyses
- Apply estimand framework principles and intercurrent event handling consistent with ICH E9(R1)
- Build the PRO/COA statistical capability, defining its scope, standards, and approach
- Design compliance- and audit-ready workflows and documentation aligned with applicable standards
- Establish standardized templates and quality-control practices
- Build reusable, scalable R-based analytical tools using functional programming principles
- Maintain current knowledge of regulatory and methodological requirements across EU JCA, national European HTA bodies, EMA, FDA, and ICH
- Manage Biostatisticians, including performance management, technical coaching, and career development
- Serve as senior escalation point for complex or high-risk methodological questions
- Scope statistical work, develop estimates and budgets, and contribute to proposals and bid defenses
- Represent the practice in client-facing capability discussions as a technical subject-matter expert
Requirements
What you’ll need- 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, including 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 such as JCA Appendix D.3 standards
- Proven expertise in HTA and regulatory expectations for PRO/COA evidence across the EU, key national bodies including IQWiG/G-BA, HAS, NICE, EMA, and FDA
- 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
- 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 technical and non-technical stakeholders
Benefits
Comp & perks- Competitive salary
- Bonus
- Pension
- Private Healthcare
- Dental Cover
- Enhanced Eye Care Cover
- Electric Car Scheme
- Staggered working hours
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
PRO/COA Statistical MethodologyMMRMResponder AnalysesMultiple ImputationEstimand Framework ApplicationLongitudinal Data AnalysisStatistical Process DevelopmentEvidence-Synthesis DocumentationFunctional ProgrammingStatistical Analysis
Soft Skills
Strong Communication SkillsTechnical CoachingPerformance ManagementClient-Facing RepresentationAutonomy
Industry Keywords
BiostatisticsLife Sciences ConsultingHTARegulatory ExpectationsEU JCAFDAEMAIQWiG/G-BAHASNICE