Associate Director providing statistical leadership and support for biopharmaceutical clinical studies. Collaborating with cross-functional teams to ensure data integrity and compliance in study deliverables.
Responsibilities
Represent the statistics function and provide statistical leadership in support of clinical studies or projects
Contribute to the planning and lead the delivery of the statistical components to support the analysis and reporting needs of clinical studies/projects
Conduct ad hoc and exploratory analyses to support Medical Affairs and commercial needs
Provide statistical input to study reports, regulatory documents, publications, and other internal or external data requests
Perform statistical modeling and analyses as needed
Requirements
M.S. in Statistics/Biostatistics is required, Ph.D. is preferred
Minimum 6 years of relevant experience in the biopharmaceutical industry
Hands-on experience in all tasks of a Study Statistician (at least 4 years) or Lead Statistician (at least 2 years)
Experience with late-stage drug development, regulatory submissions, registries, or Health Authority interactions is a plus
Extensive experience with study designs, power/sample size computations, (longitudinal) data analysis, and simulations
Proficiency in SAS programming to produce ad hoc tables, listings and figures
Experience with other statistical software such as R preferred
Ability to manage multiple tasks with competing timelines
Benefits
premium health
financial
work-life and well-being offerings for eligible employees and dependents
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