Biostatistician

Overview / About us The Biostatistician executes statistical analyses of patient-centered outcomes (PCO), including patient-reported outcome (PRO) and clinical outcome assessment (COA)-related endpoints, in direct support of the Director, Biostatistics' PRO/COA methodology workstream. Working within the standards, templates, and R-based tooling the Director establishes, this role performs hands-on PRO efficacy analyses (e.g., MMRM, responder analyses, Time to Deterioration), applies the estimand framework and intercurrent event handling consistent with ICH E9(R1), and supports development of compliance- and audit-ready documentation for EU Joint Clinical Assessment (JCA) submissions under Regulation 2021/2282 and related dossiers. This role owns execution of assigned analyses from planning through reporting and translates complex statistical findings into decision-ready outputs for technical and non-technical audiences, partnering directly with Sponsors and internal cross-functional teams to deliver scientifically rigorous work within consulting timelines. Responsibilities / Position overview PRO/COA Statistical Execution - Executes JCA analyses, related PRO analyses, and post-hoc PRO analyses of US trials as directed by the Director, Biostatistics. - Performs PRO efficacy analyses including MMRM, ANCOVA, responder analyses, and Time to Deterioration (TTD), consistent with methodology and standards established by the Director. - Applies multiple imputation and other missing-data methods (e.g., tipping point analysis, pattern mixture modeling, as directed) to address missingness in longitudinal PRO/COA data. - Supports development and application of Minimal Important Difference (MID) thresholds for responder analyses, under Director oversight. - Applies estimand framework principles and intercurrent event handling consistent with ICH E9(R1). - Conducts subgroup and effect-modification analyses to characterize how patient-centered treatment benefit varies across populations and PICOs. Statistical Strategy Input & Study Design Support - Contributes to fit-for-purpose analytic strategies for PCO under the Director's direction, aligned to study objectives, evidence needs, and stakeholder context. - Articulates key assumptions, tradeoffs, and limitations of assigned analyses to support decision-making under real-world constraints. Statistical Analysis Planning & Documentation - Prepares clear, reviewable analysis plans and technical documentation (SAP-style methods documents, analysis specifications, output shells) using templates and standards established by the Director, ensuring transparency, reproducibility, and audit readiness. - Contributes documentation aligned to JCA dossier appendix requirements (protocols, SAPs, evidence-synthesis reports, programming code), including JCA Appendix D.3 evidence-synthesis standards. Methods for Challenging PRO/COA Data - Selects and applies appropriate approaches for skewed, bounded, categorical, and longitudinal PRO/COA data, including missing data handling and sensitivity analyses, consistent with Director-defined methodology. Trial PRO Endpoint Analysis & Post-hoc Analysis - Designs and implements statistical approaches for analyzing PRO/COA endpoints in interventional studies, aligned to protocol objectives and Director-set standards. - Conducts post-hoc analyses of clinical trial data to identify additional treatment benefits or insights related to patient-centered outcomes. COA/PRO Evidence Packages - Authors or contributes to JCA submission dossiers (e.g., PICO-specific summaries) and statistical/quantitative sections of COA regulatory dossiers, under Director review. Results Interpretation & Reporting - Interprets analytical results and develops clear, decision-ready reports and evidence narratives suitable for both technical and non-technical audiences. Statistical Programming in R - Develops and executes statistical programming in R using the reusable, functional-programming-based tools and traceable, quality-controlled workflows established by the Director, to deliver reviewable outputs in a collaborative programming environment. Sponsor Partnership & Consulting Delivery - Partners with Sponsors and internal cross-functional teams as a consultative methodological resource; maintains strong client relationships by delivering scientifically rigorous analyses while staying responsive to timelines, including JCA submission deadlines tied to EMA centralized procedure timing. Qualifications - Master’s degree or higher in Biostatistics, Statistics, Quantitative Psychology/Psychometrics, or a related quantitative discipline. - 3–5 years of experience designing and executing statistical analyses in an applied setting (life sciences consulting, health outcomes research, applied academic/medical research, or similar), including end-to-end delivery from analysis planning through reporting. - Experience analyzing PICOs and PRO/COA endpoints in interventional clinical trials and translating results into stakeholder-relevant evidence. - Demonstrated expertise applying trial-aligned statistical methods for PRO endpoints, as applicable (e.g., MMRM, ANCOVA, logistic regression, responder analyses, non-parametric approaches when appropriate), including missing data handling and sensitivity analyses. - Working knowledge of estimand framework principles and intercurrent event handling consistent with ICH E9(R1). - Working knowledge of the EU HTA Regulation (2021/2282) and JCA process, including PICO scoping methodology and awareness that a single JCA may involve multiple member-state-specific PICOs; familiarity with national HTA body considerations (e.g., IQWiG/G-BA, HAS, NICE) and FDA/EMA PRO guidance a plus. - Proficiency in R for statistical programming, including the ability to apply functional-programming-based tools and own analysis workflows end-to-end (data-to-results-to-reporting) using reproducible, reviewable code. - Experience preparing analysis plans and technical reports using standardized templates to ensure consistency, efficiency, and audit-ready documentation. - Demonstrated ability to communicate modeling decisions, diagnostics, limitations, and implications clearly to non-technical stakeholders. - Experience working in a quality-controlled and collaborative programming environment. - Experience leveraging emerging AI tools to scale statistical programming and enhance scientific writing efficiency while maintaining analytical rigor and documentation quality. - Direct experience contributing to a JCA dossier (e.g., Appendix D.3 evidence synthesis) preferred but not required. Benefits - Competitive salary - Bonus - Pension - Private Healthcare - Dental Cover - Enhanced Eye Care Cover - Electric Car Scheme - Staggered working hours Originally posted on Himalayas