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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. Participates in and presents at external meetings 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 methodologies and endpoint definitions.
6. Prepares and reviews statistical parts of protocols, and briefs CROs on statistical analysis conduct, including review of analysis plans, study reports, and data lock procedures.
7. Collaborates with clinicians to interpret and communicate results accurately.
8. Supports dossier submissions and responds to statistical inquiries.
9. Develops and executes integration plans for internal data analysis, enhancing knowledge through data integration, meta-analyses, and exploration activities.
10. Manages external statisticians working on clinical trial data analysis, providing guidance on methodological and statistical deliverables.
11. Keeps up-to-date with statistical literature, attends conferences, and collaborates with peers to improve expertise.
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