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Job responsibilities (but not limited to):
1. Coordinates, provides, and delivers methodological and statistical expertise and/or statistical analyses to support the Clinical Development portfolio and Strategic Medical Affairs, ensuring compliance with international, regulatory guidelines, policies, and standards. Manages the operational aspects of statistical work outsourced to CROs.
2. Manages multiple projects across various therapeutic areas.
3. Attends and presents at external meetings related to Statistics, 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 clinical studies, and determining sample sizes. Writes and reviews the statistical components of protocols.
5. Briefs CROs on statistical analysis conduct, reviews analysis plans, participates in Blind Data Reviews, 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 strategic and detailed integration plans for internal data analysis in collaboration with Clinical, ensuring proper execution. Explores data through integration and data utilization activities like meta-analyses.
8. Manages external statisticians working on clinical trial data analysis, providing guidance on methodological and statistical deliverables.
9. Keeps current with statistical literature, attends conferences and courses, and collaborates with other statisticians to learn about new methodologies, maintaining high expertise in statistical and clinical content.
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