1113# Principal Programmer– CDISC Compliance & FDA Submission Conformance Consultant (Remote)
Skills
- Deep expertise in CDISC standards (SDTM and ADaM) and FDA Technical Conformance Guide
- Hands-on experience performing compliance and conformance checks for submission packages
- Proficiency in SAS programming for data management and dataset validation
- Experience with conformance checking tools (e.g., Pinnacle 21) and define.xml validation
- Strong problem-solving and stakeholder management skills to communicate issues and resolutions
- Familiarity with submission publishing workflows and eCTD structure (preferred)
Responsibilities
- Review and validate clinical data submission packages for compliance with FDA Technical Conformance Guide (TCG) and CDISC standards
- Perform comprehensive conformance checks of SDTM and ADaM datasets and resolve data and metadata issues
- Collaborate with statistical programming, biostatistics, data management, and regulatory teams to identify and remediate compliance gaps
- Provide standardized guidance and best practices to biotech sponsors on FDA submission expectations
- Ensure submission deliverables (datasets, define.xml, metadata) are audit-ready and aligned with regulatory timelines
- Act as a subject matter expert for CDISC implementation, FDA TCG, and conformance checking tools
- Mentor and guide junior programmers on compliance checks, tools, and submission workflows
Education
- Advanced degree in Statistics, Computer Science, Life Sciences, or related field (Master's or PhD preferred)
- Relevant certifications or formal training in CDISC standards are a plus
Benefits
- Work directly for a single sponsor while employed by a global CRO offering career growth
- Professional development and continuous training resources
- Remote, flexible work arrangement
- Exposure to global regulatory submission practices and cross-functional teams
- Inclusive, supportive company culture with emphasis on quality and low turnover
Average salary estimate
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Our mission is to be a valuable partner to our clients by providing a wide variety of services for product development and regulatory submissions. We continuously strive to raise the standard of excellence through accuracy and efficiency. This re...
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