Director, Biostatistics
Core
Director of Biostatistics leading clinical trial design, statistical support for drug development, and regulatory submissions within a therapeutic area.
Role type
Senior IC biostatistician (Director level)
Builds
Clinical trial designs and statistical analyses supporting regulatory approval and market access
Domain
Pharmaceutical industry, oncology/hematology/cell therapy/immunology/cardiovascular/neuroscience
Required skills
Biostatistics, Clinical trial design, SAS, R, Python, Regulatory agency interactions, Statistical programming, Advanced statistical analysis, Data manipulation, Graphing, Simulation, Leadership, Budget management
Preferred skills
Management experience (3+ years), Workforce planning, Talent management strategy
Technologies
SAS, R, Python
Responsibilities
Drive innovative and efficient study design; Lead statistical support for compound development; Provide guidance and management to statisticians; Engage as a strategic partner in drug development; Present and defend statistical solutions to governance and regulatory bodies; Contribute to Clinical Development Plans and submission activities; Manage functional/project budget and allocate resources; Represent company at professional societies; Coach and mentor team members.
Seniority
Director, hands-on IC with management responsibilities