Responsibilities
- Serve as the primary contact for statistical inquiries across project teams, clients, vendors, and internal staff
- Perform statistical evaluations for clinical studies, including interim and final analyses, DSMB/DMC reporting, and pharmacokinetic assessments
- Create and evaluate study protocols, statistical analysis plans, and dataset specifications aligned with CDISC ADaM standards and project requirements
- Examine statistical outputs including tables, figures, listings, and analysis-ready datasets for accuracy and compliance
- Deliver onboarding training for statisticians and SAS programmers and lead project-specific statistical instruction
- Prepare for and engage in internal and external audits related to statistical activities
- Support audit follow-up actions and contribute to resolution of findings related to statistical work
- Contribute to the development and revision of standard operating procedures and quality system documentation in biostatistics
- Collaborate with data managers on statistical aspects of data discrepancies or data-related challenges
- Support business development through participation in bid defense meetings and project initiation sessions
- Supervise and coordinate teams of SAS programmers and statisticians at the project level
Work Arrangement
Remote (Worldwide)
