ClinChoice is seeking a Principal Programmer– CDISC Compliance & FDA Submission Conformance Consultant to ensure clinical data deliverables are audit-ready and fully compliant with FDA regulations and CDISC standards. You will play a key role in accelerating the development of innovative drugs by providing standardized guidance to biotech companies on submission expectations.

What You'll Do

Review and validate clinical data submission packages to ensure compliance with the FDA Technical Conformance Guide, CDISC standards, and regulatory requirements.
Perform comprehensive conformance checks of SDTM and ADaM datasets for accuracy and adherence to industry standards.
Collaborate with statistical programming, biostatistics, data management, and regulatory teams to identify, troubleshoot, and resolve compliance issues.
Provide standardized guidance to biotech companies on FDA submission requirements, best practices, and expectations.
Ensure submission deliverables are audit-ready and aligned with regulatory timelines.
Act as a subject matter expert in FDA TCG, CDISC implementation, and submission conformance activities.
Mentor and guide team members on CDISC compliance, conformance checking tools, and regulatory submission processes.

What We're Looking For

Advanced degree in Statistics, Computer Science, Life Sciences, or a related field (Master’s or PhD preferred).
8+ years of experience in statistical programming, data standards, or regulatory compliance within the pharmaceutical/biotech industry.
Strong expertise in CDISC standards (SDTM, ADaM) and FDA submission requirements, including the FDA Technical Conformance Guide.
Proven hands-on experience performing compliance and conformance checks for submission data packages.
Proficiency in SAS programming and familiarity with conformance checking tools like Pinnacle 21 and Define.xml validation.
Strong problem-solving skills with the ability to provide clear guidance to cross-functional teams.
Excellent communication and stakeholder management skills.

Nice to Have

Prior experience as a Principal Programmer, Principal Data Standards Specialist, or equivalent.
Experience with global regulatory submissions (FDA, EMA, PMDA).
Demonstrated ability to work independently and lead compliance/conformance review activities.
Familiarity with eCTD structure and submission publishing workflows.