Job responsibilities (but not limited to):
1. Coordinate, provide, and deliver methodological and statistical expertise and analyses to support the Clinical Development portfolio and Strategic Medical Affairs, ensuring compliance with international, regulatory guidelines, policies, and standards.
2. Manage the operational aspects of statistical work outsourced to CROs, overseeing multiple projects across various therapeutic areas.
3. Participate and present at external meetings such as Investigators Meetings, Regulatory Agencies, and Advisory Boards.
4. Provide statistical and methodological support to EPD, including input into Clinical Development Plans and study protocols, ensuring appropriate methodology and endpoint definitions, and responsible for sample size determination and protocol review.
5. Brief CROs on statistical analysis conduct, review analysis plans, participate in Blind Data Reviews, and approve database lock and unblinding processes.
6. Collaborate with clinicians to interpret and communicate results accurately to various stakeholders.
7. Support dossier submissions by addressing statistical questions.
8. Develop and execute integration plans for internal data, enhancing knowledge through data integration, meta-analyses, and data exploration activities.
9. Manage external statisticians working on clinical trial data analysis and coordinate with CROs on deliverables.
10. Stay updated with statistical literature, attend conferences, and collaborate with other statisticians to learn new methodologies, maintaining high proficiency in statistical and clinical content.
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