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 (Associate Director)
Builds
Clinical development projects and regulatory submission packages
Domain
Pharmaceutical / Biostatistics
Required skills
statistical methodology, clinical trial design, regulatory submission strategy, protocol development, statistical analysis planning, team leadership, cross-functional partnership, data presentation, external liaison
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; Partner with Clinical, Regulatory, and Patient Safety functions to create development strategies; Propose novel statistical methodological approaches for study design; Train and mentor staff on statistical methodology; Act as liaison for statistical issues with CROs, academic institutions, and government agencies; Ensure compliance with regulatory requirements and validate external statistical software.