Associate Director, Statistics (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 biostatistician (clinical development)
Builds
Clinical trial protocols, statistical analysis plans, regulatory submission documents, and scientific publications
Domain
Pharmaceutical industry, clinical trials, biostatistics
Required skills
statistical methodology, clinical trial design, regulatory compliance, data analysis, protocol development, statistical programming, team leadership, cross-functional collaboration
Preferred skills
immunology clinical trial experience, PhD in statistics or biostatistics
Technologies
external statistical software
Responsibilities
Lead statistical strategy for project development and regulatory submission; Independently develop protocols and statistical analysis plans; Train and mentor staff on statistical methodology; Act as liaison for statistical issues with CROs and academic institutions; Ensure compliance with regulatory requirements for work processes
Seniority
Senior, hands-on IC with management responsibilities