Medical Affairs Team Lead - Clinical Evidence and Statistics
Core
Leading the Clinical Evidence and Statistics function to oversee clinical evidence generation, study design, statistical operations, and data analysis for genomic product development and regulatory submissions.
Role type
Senior Medical Affairs Team Lead (Clinical Evidence & Statistics)
Builds
Clinical evidence packages, statistical analysis plans, and scientific reports for regulatory submissions and market access.
Domain
Genomics / Clinical Research / Regulatory Affairs
Required skills
Clinical study design, statistical methodology, regulatory compliance (GCP), team leadership, protocol development, data analysis, scientific reporting, SOP management, audit support, R programming
Preferred skills
Experience with automated reporting workflows, advanced statistical modeling, cross-functional collaboration
Technologies
R, Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs)
Responsibilities
Line management for Medical Affairs Scientists and Analysts; Lead planning, design, execution, and reporting of clinical evidence; Provide expert input into study design and statistical methodologies; Oversee statistical analyses and review outputs; Ensure studies comply with GCP and regulations; Support audits and inspections; Drive continuous improvement of analytical processes.
