Role Summary
As a Principal Statistician with a focus on pharmacokinetics, you will take ownership of statistical leadership across international clinical studies. You will serve as the primary point of contact for biostatistical matters, working closely with project teams, clients, and internal departments to ensure accurate and compliant data analysis and reporting.
Key Responsibilities
- Lead statistical input for clinical trial protocols, analysis plans, and dataset specifications aligned with CDISC ADaM standards
- Perform and oversee pharmacokinetic, interim, and final analyses, including those supporting Data Safety Monitoring Boards
- Review tables, listings, figures, and analysis datasets to ensure accuracy and consistency
- Collaborate with data management on data-related statistical issues
- Supervise and coordinate teams of statisticians and SAS programmers on assigned projects
- Contribute to bid defenses, project kick-offs, and client-facing discussions
- Develop and deliver training sessions for team members on statistical practices and project needs
- Support internal and external audits by preparing documentation and participating in review processes
- Provide feedback on standard operating procedures and quality documentation within biostatistics
Technical Requirements
Experience with CDISC ADaM standards is essential for defining and validating analysis datasets. The role demands strong technical understanding of statistical programming outputs and regulatory expectations.
