Associate Director, Biostatistics
Core
Associate Director of Biostatistics leading cross-functional development teams in trial design, protocol development, analysis planning, and regulatory submissions for clinical assets.
Role type
Senior IC Biostatistician (Management)
Builds
Clinical trial protocols, statistical analysis plans, clinical study reports, and regulatory submissions
Domain
Pharmaceutical / Clinical Development / Biostatistics
Required skills
Clinical trial design, Statistical analysis planning, Regulatory submission preparation, Team leadership, Project management, SAS/R/Python, Clinical study reporting, Health authority interaction
Preferred skills
People management experience, Therapeutic area expertise
Technologies
SAS, R, Python
Responsibilities
Collaborate in design of innovative and efficient clinical trials, Defend protocols and analysis plans at internal governance reviews, Independently author and/or review protocol and clinical study reports, Present summary data and analyses results, Provide statistical support for health authority requests, Manage multiple studies to ensure consistency and adherence to standards, Develop and advise team members, Engage as a matrix team member in the drug development process
Seniority
Senior, hands-on IC with management responsibilities