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Job responsibilities (but not limited to):
1. Coordinates, provides, and delivers methodological and statistical expertise and/or statistical analyses to support the Clinical Development portfolio and Strategic Medical Affairs, ensuring compliance with international, regulatory guidelines, policies, and standards.
2. Manages the operational aspects of statistical work outsourced to CROs.
3. Handles multiple projects across various therapeutic areas.
4. Attends and presents at external meetings related to Statistics, such as Investigators Meetings, Regulatory Agencies, and Advisory Boards.
5. Provides qualified statistical and methodological support to EPD, including input into Clinical Development Plans and study protocols; responsible for statistical methodology and endpoint definitions in clinical study design and sample size determination; writes or reviews the statistical sections of protocols.
6. Briefs CROs on the conduct of statistical analyses for EPD Clinical Development studies, reviews analysis plans, participates in Blind Data Reviews, reviews study report tables, listings, and figures, and approves database lock and unblinding requests.
7. Communicates results and conclusions with clinicians to ensure correct interpretation by different users.
8. Supports dossier submissions and addresses statistical questions related to filings.
9. Develops strategic and detailed integration plans for internal data analysis, collaborating with Clinical teams, and ensures proper execution.
10. Maximizes data potential through integration and utilization activities like meta-analyses and data explorations.
11. Manages external statisticians working on clinical trial data analysis, and briefs CROs on deliverables.
12. Reviews statistical literature, attends conferences and courses, and collaborates with other statisticians to stay updated on new methodologies and maintain high expertise.
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