Principal Programmer– CDISC Compliance & FDA Submission Conformance Consultant (Remote)

We are seeking a highly experienced professional to join our team as a Principal Programmer– CDISC Compliance & FDA Submission Conformance. In this role, you will be responsible for ensuring that clinical data deliverables meet FDA regulatory requirements, CDISC (SDTM and ADaM) standards, and the FDA Technical Conformance Guide (TCG). This position requires deep expertise in performing compliance and conformance checks for submission data packages and providing standardized guidance to biotech companies on FDA submission expectations. Key Responsibilities include reviewing and validating clinical data submission packages, performing conformance checks of SDTM and ADaM datasets, and collaborating with teams to resolve compliance issues.