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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 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, and oversees statistical methodology and endpoint definitions for clinical studies.
6. Writes and reviews the statistical sections 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, ensuring correct interpretation of results in collaboration with clinicians.
9. Supports dossier submissions and responds to statistical inquiries.
10. Develops integration plans for internal compound data, 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. Reviews statistical literature, attends conferences, and courses to maintain high statistical expertise and keep up-to-date with new methodologies.
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