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Job Responsibilities
1. Coordinate, provide, and deliver methodological and statistical expertise and analyses, supporting the Clinical Development portfolio and Strategic Medical Affairs in compliance with international, regulatory guidelines, policies, and standards.
2. Manage operational aspects of statistical work outsourced to CROs.
3. Handle multiple projects across various therapeutic areas.
4. Present at external meetings such as Investigators Meetings, Regulatory Agencies, and Advisory Boards.
5. Provide statistical and methodological support to EPD, including input into Clinical Development Plans and study protocols, ensuring appropriate methodology and endpoint definitions.
6. Review and approve statistical analysis plans, study report tables, listings, and figures, and oversee database lock and unblinding processes.
7. Collaborate with clinicians to interpret and communicate results accurately.
8. Support dossier submissions and respond to statistical queries.
9. Develop integration plans for internal data analysis, ensuring proper execution and data utilization activities like meta-analyses and data explorations.
10. Manage external statisticians working on clinical trial data analysis and coordinate with CROs on deliverables.
11. Stay updated with statistical literature, attend conferences, and participate in courses to maintain high expertise and proficiency.
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