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Job responsibilities (but not limited to):
1. Coordinates, provides, and delivers methodological and statistical expertise and/or statistical analyses. Supports both the Clinical Development portfolio and Strategic Medical Affairs in their support to Affiliates, complying with international, regulatory guidelines, policies, and standards.
2. Directs the operational aspects of statistical work outsourced to CROs.
3. Manages multiple projects across more than one therapeutic area.
4. Attends and presents at external meetings for Statistics (e.g., Investigators Meetings, Regulatory Agencies, Advisory Boards).
5. Provides qualified statistical and methodological support to EPD, including input into Clinical Development Plans and study protocols. Responsible for selecting appropriate statistical methodologies and endpoint definitions for clinical studies and sample size determinations. Writes and reviews the statistical parts of protocols.
6. Briefs CROs on conducting statistical analyses of EPD Clinical Development studies, including review of statistical analysis plans, participation in Blind Data Reviews, and review of study report tables, listings, and figures. Approves database lock and requests unblinding for analysis. Communicates results and conclusions clearly to ensure correct interpretation by users.
7. Supports dossier submissions and addresses statistical questions related to filings.
8. Develops integration plans for internal compound data analyses in collaboration with Clinical, ensuring proper execution. Explores data to enhance knowledge through data integration activities like meta-analyses and data explorations.
9. Manages external statisticians analyzing EPD clinical trial data and briefs CROs on methodological and statistical deliverables.
10. Keeps up-to-date by reviewing statistical literature, attending conferences, and courses. Collaborates with other statisticians to learn new methodologies and maintains high expertise in relevant statistical and clinical content areas.
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