Statistical Programmer II

A Regulatory/Statistical Programmer at Parexel coordinates project start-up activities, creates global programs, and produces high-quality derived datasets like SDTM and ADaM for clinical trials. The role involves ensuring compliance with ICH-GCP and 21 CFR Part 11 standards while maintaining documentation for regulatory inspections and audits. Key duties include mentoring staff, participating in quality improvement initiatives, and adhering to strict SOPs in a global clinical development environment.