Job Description

• The Study Lead Statistician (SLS) for product facing work is responsible for leading statistical activities of clinical studies and should be able to work independently with minimal guidance
• The SLS works closely with cross-functional team members to ensure their clinical studies are appropriately planned, have the required statistical power for success, comply with Regulatory requirements and Client standards, and maintain statistical, as well as operational, integrity throughout the life of the study
• The SLS works closely with the Global Statistical Lead to ensure their study aligns with the overall product strategy.
• The SLS also works closely with the Study Statistician, who performs all the operational activities related to the statistics-related deliverables.
• The SLS should provide supervision and guidance to the Study Statistician.
• The SLS is responsible for the integrity and quality of their study.
• The SLS also supports product level activities that could include Regulatory activities, exploratory analyses, as well as publication/literature review and QCing publication work.
• Provide statistical guidance, review, and be responsible for statistical analysis of individual studies/projects.
• Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as the statistical analyses of these endpoints (programmatically).
• Perform data-driven modeling during clinical studies.
• Coordinate the creation of required outputs for Dose Level Review Meetings (DLRMs) as well as coordinate and participate in the DLRM.

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