Principal Programmer - FDA Compliance

Job Summary

A company is looking for a Principal Programmer- CDISC Compliance & FDA Submission Conformance Consultant.

Key Responsibilities

• Review and validate clinical data submission packages for compliance with FDA TCG, CDISC standards, and regulatory requirements
• Perform conformance checks of SDTM and ADaM datasets, ensuring accuracy and adherence to industry standards
• Collaborate with cross-functional teams to identify and resolve compliance issues and provide guidance on FDA submission expectations

Qualifications & Skills

• Advanced degree in Statistics, Computer Science, Life Sciences, or related field (Master's or PhD preferred)
• 8+ years of experience in statistical programming, data standards, or regulatory compliance in the pharmaceutical/biotech industry
• Strong expertise in CDISC standards (SDTM, ADaM) and FDA submission requirements
• Proficiency in SAS programming and familiarity with conformance checking tools
• Prior experience as a Principal Programmer or equivalent role is preferred