Principal Statistician responsible for directing statistical components of international clinical studies, serving as the primary contact for statistical matters across client, vendor, and internal teams. This position ensures accurate and timely delivery of analyses while maintaining adherence to regulatory guidelines and quality standards.
Key Responsibilities
- Serve as the main liaison for statistical inquiries from project teams, sponsors, and external partners
- Design and execute statistical analyses for clinical trials, including interim, final, and pharmacokinetic assessments, as well as reporting for Data Safety Monitoring Boards
- Author and validate study protocols, statistical analysis plans, and dataset specifications aligned with CDISC ADaM standards
- Review output including tables, listings, figures, and analysis datasets for technical accuracy and consistency
- Lead onboarding and training initiatives for biostatistics staff and SAS programming teams
- Support internal and regulatory audits by preparing documentation and participating in review meetings
- Contribute to the development and refinement of departmental SOPs and Quality System Documents
- Collaborate with data management on data-related statistical issues
- Support business development through participation in bid defenses and project kick-off sessions
- Supervise and coordinate teams of statisticians and SAS programmers on assigned studies
Technical Expertise
Proficiency in SAS and in-depth knowledge of CDISC ADaM standards are essential for successful performance in this role. Experience with regulatory compliance and data standards in clinical development is a core requirement.
