Responsible for leading statistical programming activities to support various clinical trial projects, you'll build programming processes for clinical studies and submissions. Managing programmers and CROs, you will oversee programming activities and provide timely support to cross-functional teams on statistical programming matters.
We are seeking a Principal Programmer to ensure clinical data deliverables meet FDA regulatory requirements, CDISC standards, and the FDA Technical Conformance Guide (TCG). This position requires expertise in performing compliance and conformance checks for submission data packages. You will provide standardized guidance to biotech companies on FDA submission expectations.
This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences. Uses understanding of clinical trial concepts and cross-functional protocol requirements to execute assigned study assignments. Engages with members of the DSS and cross-functional study teams in order to effectively execute assigned activities. Effectively utilizes available technology to execute assigned activities.