Work closely with the Biometrics Project Lead in providing statistical support to clinical studies
Serve as the lead statistician of late-stage trials and drive statistical strategy & execution
Oversee statistical aspects of trials to ensure all requirements are met
Provide statistical knowledge in study design, analysis, reporting, and interpretation
Conduct statistical analyses and oversee external vendors
Collaborate with cross-functional teams to ensure quality of Biometrics deliverables
Contribute to the development of Biometrics-related SOPs and technical documents
Research and apply new statistical methodologies as needed

M.S. in Statistics/Biostatistics is required, Ph.D. is preferred
Minimum 6 years of relevant experience in the biopharmaceutical industry
Hands-on experience as a Study Statistician (at least 4 years) or Lead Statistician (at least 2 years)
Vendor oversight & management experience
Knowledge of the drug development process
Understanding of FDA and ICH requirements
Extensive experience with study designs, power/sample size computations, (longitudinal) data analysis, and simulations
Proficiency in SAS programming, experience with R preferred
Experience with data pooling to support reports and publications
Ability to manage multiple tasks with competing timelines
Excellent communication and collaboration skills

Associate Director – Biostatistics

Key skills