Responsibilities

The Principal Statistical Programmer will lead statistical programming activities on clinical projects, including complex projects, providing support in identifying project scope changes and potential risks. They will produce high-quality deliverables, specify and program CDISC SDTM and ADaM datasets, create and validate randomization lists, ensure compliance to SOPs, report deviations and manage CAPAs, provide supervision and mentoring to the programming team, prepare training materials, identify areas for improvement, and communicate effectively with project teams. They will also support Quality Assurance in audits and maintain an effective statistical programming department.