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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. Manages outsourced statistical work to CROs.
2. Handles multiple projects across various therapeutic areas.
3. Attends and presents at external meetings such as Investigator Meetings, Regulatory Agencies, and Advisory Boards.
4. Provides statistical and methodological support to EPD, including input into Clinical Development Plans and study protocols. Responsible for selecting appropriate statistical methodologies and endpoint definitions, designing studies, and determining sample sizes. Reviews and writes parts of the statistical protocol.
5. Briefs CROs on statistical analysis conduct, reviews analysis plans, participates in Blind Data Reviews, and reviews study report tables, listings, and figures. Approves database lock and requests unblinding for analysis. Collaborates with clinicians to interpret and communicate results accurately.
6. Supports dossier submissions and responds to statistical queries related to filings.
7. Develops integration plans for internal compound data, ensuring proper execution and leveraging data for insights through activities like meta-analyses and data exploration.
8. Manages external statisticians working on clinical trial data analysis, providing guidance on deliverables.
9. Reviews current statistical literature, attends conferences and courses, and collaborates with other statisticians to stay updated on new methodologies and clinical content expertise.
J-18808-Ljbffr