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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, 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, ensuring appropriate statistical methodology and endpoint definitions.
6. Prepares and reviews the statistical parts of study protocols and briefs CROs on statistical analysis conduct, including review of analysis plans, study report tables, listings, and figures.
7. Approves database lock and requests unblinding for analysis, and collaborates with clinicians to interpret and communicate results accurately.
8. Supports dossier submissions and responds to statistical questions related to filings.
9. Develops strategic and detailed integration plans for internal data analysis, ensuring proper execution and data utilization activities like meta-analyses and data exploration.
10. Leads external statisticians working on clinical trial data analysis and briefs CROs on deliverables.
11. Reviews statistical literature, attends conferences, and pursues continuous learning to maintain high statistical expertise and proficiency in relevant methodologies and clinical content.
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