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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. 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 for Statistics, such as Investigators Meetings, Regulatory Agencies, and Advisory Boards.
4. Provides qualified statistical and methodological support to EPD, including input into Clinical Development Plans and study protocols. Responsible for selecting appropriate statistical methodologies, defining endpoints, and determining sample sizes. Writes and reviews the statistical sections of protocols.
5. Briefs CROs on conducting statistical analyses of EPD Clinical Development studies, reviews analysis plans, participates in Blind Data Reviews, and approves study database lock and unblinding procedures. Clarifies and communicates results to ensure correct interpretation.
6. Supports dossier submissions and responds to statistical questions related to the filings.
7. Develops strategic and detailed data integration plans in collaboration with Clinical for internal compound data analysis, ensuring proper execution.
8. Maximizes data potential through integration and utilization activities such as meta-analyses and data explorations.
9. Manages external statisticians working on clinical trial data analysis and briefs CROs on methodological and statistical deliverables.
10. Reviews statistical literature, attends conferences and courses to maintain high expertise, and collaborates with other statisticians to learn new methodologies and stay updated in statistical and clinical content expertise.
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