What You'll Do
Take ownership of statistical leadership across international clinical trial projects, guiding end-to-end analysis and serving as the primary point of contact for statistical matters. Collaborate with project teams, clients, and vendors to ensure accurate interpretation and application of statistical methods.
Design and execute analyses including interim, final, pharmacokinetic (PK), and data monitoring committee (DSMB/DMC) reporting. Contribute to the development of study protocols, statistical analysis plans, and analysis dataset specifications aligned with CDISC ADaM standards.
Review analytical outputs such as tables, listings, figures, and datasets for accuracy and consistency. Support audit readiness by preparing for and participating in internal and external audits, and assist in follow-up actions.
Lead training initiatives for statisticians and SAS programmers, both for onboarding and project-specific needs. Provide input into departmental processes, including standard operating procedures and quality documentation.
Work closely with data management on data-related statistical concerns and contribute to bid defenses and project kick-off meetings. Supervise teams of statisticians and SAS programmers, ensuring high-quality deliverables across multiple studies.
Requirements
- Proven experience in biostatistics within clinical research
- Strong command of SAS programming for clinical trial analysis
- Thorough understanding of CDISC ADaM standards
- Experience leading statistical teams and managing complex projects
- Familiarity with regulatory requirements and audit processes
- Ability to train and mentor technical staff
Benefits
This role supports a globally flexible work environment, enabling collaboration across regions with adaptable scheduling to suit project demands. Opportunities include professional growth through leadership responsibilities and involvement in diverse therapeutic areas and study phases.
