Principal Programmer – CDISC Compliance & FDA Submission Conformance Consultant - Remote

Overview

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds. ClinChoice is searching for a Principal Programmer– CDISC Compliance & FDA Submission Conformance Consultant to join one of our clients.

In Short

• Review and validate clinical data submission packages for FDA compliance.
• Perform conformance checks on SDTM and ADaM datasets.
• Collaborate with cross-functional teams to resolve compliance issues.
• Provide guidance on FDA submission requirements.
• Ensure submission deliverables are audit-ready and compliant.
• Act as a subject matter expert in FDA TCG and CDISC standards.
• Mentor team members on regulatory submission processes.

Requirements

• Advanced degree in Statistics, Computer Science, or Life Sciences.
• 8+ years of experience in statistical programming and regulatory compliance.
• Expertise in CDISC standards (SDTM, ADaM) and FDA submission requirements.
• Experience in compliance and conformance checks for submission data.
• Proficiency in SAS programming and conformance checking tools.
• Strong problem-solving and communication skills.

Benefits

• Work with a global full-service CRO.
• Opportunities for professional development.
• Supportive company culture.
• Ability to work independently.
• Diverse and inclusive work environment.