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Job responsibilities (but not limited to):
1. Coordinates, provides, and delivers methodological and statistical expertise and/or statistical analyses, supporting both the Clinical Development portfolio and Strategic Medical Affairs in compliance with international, regulatory guidelines, policies, and standards.
2. Directs the operational aspects of statistical work outsourced to CROs.
3. Manages multiple projects across various therapeutic areas.
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, ensuring appropriate statistical methodology and endpoint definitions.
6. Writes and reviews the statistical parts of protocols.
7. Briefs CROs on the conduct of statistical analyses, reviews analysis plans, participates in Blind Data Reviews, and reviews study report tables, listings, and figures.
8. Approves database lock and requests unblinding for analysis, and communicates results and conclusions clearly to ensure correct interpretation.
9. Supports dossier submissions and addresses statistical questions related to filings.
10. Develops strategic and detailed integration plans for internal compound data analysis, ensuring proper execution and data utilization activities like meta-analyses and data explorations.
11. Manages external statisticians working on clinical trial data analysis and briefs CROs on deliverables.
12. Keeps up to date with statistical literature, attends conferences and courses, and collaborates with other statisticians to learn about new methodologies.
This job posting is active and not expired.
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