Associate Director - Statistics, Specialty TA (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 Associate Director (Statistics)
Builds
Clinical trial protocols, statistical analysis plans, regulatory submission documents, and scientific publications.
Domain
Pharmaceutical industry, clinical research, biostatistics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Statistical methodology, regulatory submission strategy, protocol design, data analysis, team leadership, cross-cultural team management, drug development lifecycle knowledge
Preferred skills
PhD in Statistics/Biostatistics, submission experience, innovative statistical methods
Technologies
External statistical software (validation required)
Responsibilities
Lead regulatory submission and product life-cycle management strategy; develop protocols and statistical analysis plans; mentor staff and supervise contract statisticians; act as liaison for statistical issues with CROs and agencies; ensure compliance with regulatory requirements and SOPs
Seniority
Senior, hands-on IC with management responsibilities
