02 ott - Italia
EUSA Pharma
Job PurposeWe are seeking an experienced Senior Biostatistician to provide expert methodological support across the development portfolio. The role will ensure the robust management, analysis and interpretation of data from studies of new and marketed medicines conducted directly or through CROs, including integrated and pooled analyses. The successful candidate will contribute to statistical strategy, promote contemporary methods and technologies, and support consistently high statistical standards across R&D.Key; ResponsibilitiesYou will collaborate closely with Therapeutic Area management to define robust statistical approaches to clinical trials, translate scientific questions into evidence plans and support the operational requirements of clinical development programmes.You will play an influential role in cross-functional Project Teams, providing clear statistical direction, constructively challenging assumptions and enabling evidence-based decisions throughout the development lifecycle.You will be accountable, directly or through oversight,
for high-quality statistical input to major documents, including clinical development plans, protocols, data management plans, case report forms, clinical study reports, integrated summaries of safety and efficacy, scientific publications and external data presentations. You will partner with Medical Writing and other functions to ensure scientific clarity, consistency and regulatory readiness.You will lead or supervise the development of statistical analysis plans and the production of tables, figures and listings, ensuring that approaches are scientifically rigorous, efficient and fit for purpose.You will provide expert review of clinical study protocols and statistical and data management documents, setting a high standard for quality and consistency.You will lead complex analyses and interpretation of results from clinical studies, integrated analyses and meta-analyses, communicating implications clearly to cross-functi
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