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…