Associate Director, Biostatistics
Core
Lead biostatistics for clinical trial design, analysis planning, and regulatory submissions across a specific indication or therapeutic area.
Role type
Senior IC biostatistician with people management responsibilities
Builds
Clinical study reports, statistical analysis plans, and regulatory submissions
Domain
Pharmaceutical clinical development
Required skills
Clinical trial design, statistical analysis planning, regulatory submission preparation, team leadership, project management, SAS/R/Python proficiency, statistical methodology expertise
Preferred skills
People management experience, cross-functional collaboration
Technologies
SAS, R, Python
Responsibilities
Collaborate on innovative clinical trial design and selection of study endpoints; Defend protocols and analysis plans at internal governance reviews; Author and review statistical analysis plans and clinical study reports; Present summary data and analysis results to health authorities and stakeholders; Manage multiple studies to ensure consistency within an indication; Develop and advise team members; Engage as a scientific partner in the drug development process