Biostatistician

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Authors or contributes to JCA submission dossiers (e.g., PICO-specific summaries) and statistical/quantitative sections of COA regulatory dossiers, under Director review.

• Interprets analytical results and develops clear, decision-ready reports and evidence narratives suitable for both technical and non-technical audiences.

• 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.

• 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.

• 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.

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