Associate Director, Statistics - Immunology (Hybrid)
Core
Provide statistical leadership for clinical development and life-cycle management strategies for assigned projects, including clinical trials, patient safety, and global medical affairs.
Role type
Associate Director, Statistics (Immunology)
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 leadership, cross-functional partnership, external liaison management, software validation
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 protocols and statistical analysis plans; represent the function on project teams to drive alignment; propose novel statistical methodological approaches; train and mentor staff; develop strategy for data presentation and inference; act as liaison for statistical issues with CROs and academic institutions; ensure compliance with regulatory requirements.
Seniority
Senior, hands-on IC with leadership responsibilities