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Job responsibilities (but not limited to):
1. Coordinates, provides, and delivers methodological and statistical expertise and/or analyses, supporting both Clinical Development and Strategic Medical Affairs in 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 such as Investigators Meetings, Regulatory Agencies, and Advisory Boards.
5. Provides statistical and methodological support to EPD, including input into Clinical Development Plans and study protocols, ensuring appropriate methodology and endpoint definitions.
6. Prepares and reviews statistical analysis plans, participates in Blind Data Reviews, and reviews study report tables, listings, and figures.
7. Approves database lock and requests study unblinding for analysis, communicating results and conclusions clearly to ensure correct interpretation.
8. Supports dossier submissions and addresses statistical questions related to the submission file.
9. Develops integration plans for internal compound data analysis, ensuring proper execution and data utilization activities like meta-analyses and data exploration.
10. Manages external statisticians working on clinical trial data analysis and briefs CROs on deliverables.
11. Reviews statistical literature, attends conferences, and courses to maintain high statistical expertise and stay updated on new methodologies.
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