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 me