Associate Director, Statistics - Immunology (Hybrid)
Core
Provide statistical leadership for clinical development and life-cycle management strategies, including clinical trials, patient safety, and global medical affairs.
Role type
Senior IC statistician with leadership responsibilities
Builds
Clinical trial protocols, statistical analysis plans, regulatory submission documents, and scientific publications
Domain
Pharmaceutical / Biostatistics / Immunology
Required skills
Statistical methodology, regulatory submission strategy, clinical trial design, data presentation and inference, team mentorship, external liaison with CROs and agencies
Preferred skills
Late-stage clinical trials experience, immunology clinical trials experience
Technologies
External statistical software
Responsibilities
Lead regulatory submission and product life-cycle management strategy planning; Develop and validate statistical analysis plans and protocols; Mentor staff and supervise contract statisticians; Act as liaison for statistical issues with CROs, academic institutions, and government agencies; Ensure compliance with regulatory requirements and validate external statistical software
Seniority
Senior, hands-on IC with management duties