Principal Programmer, CDISC SME
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Job Description
Principal Programmer serving as CDISC standards SME for Cytel’s pharmaceutical client. Overseeing clinical data submissions, dataset quality, governance, and cross-functional programming delivery.
Responsibilities:
- Provide CDISC subject matter expertise across clinical studies, submissions, and standards-related activities
- Interpret, implement, and oversee CDISC standards including CDASH, SDTM, ADaM, define.xml, annotated CRFs, Reviewer’s Guides, and related submission documentation
- Review datasets, annotated CRFs, define.xml, Reviewer’s Guides, and CDISC-based e-submission packages
- Ensure accuracy, consistency, traceability, compliance with client standards, and regulatory alignment
- Advise study teams, statisticians, programmers, Data Management, Technology Enabled Science, CROs, and other stakeholders
- Design data structures and specifications for SDTM and ADaM datasets, tables, figures, listings, analysis submission content, integrated summaries, and exploratory analyses
- Lead or oversee production, validation, and review of programming deliverables produced internally and by CROs
- Support CDISC and client standards governance and standardization initiatives
- Develop or review standards documentation, processes, guidance, templates, and training materials
- Provide mentorship, knowledge sharing, presentations, and training
- Identify process gaps and standards inconsistencies and develop global tools, processes, and practices to improve programming efficiency, quality, and capacity
Requirements:
- Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area
- 7+ years of statistical programming experience in a CRO/pharmaceutical environment
- Extensive hands-on experience applying CDISC standards to clinical trial and regulatory submission deliverables
- Demonstrated expertise in SDTM, ADaM, CDASH, define.xml, annotated CRFs, Reviewer’s Guides, controlled terminology, traceability, and regulatory submission expectations
- Experience reviewing, specifying, producing, validating, or overseeing CDISC-compliant datasets and submission packages
- Strong understanding of protocols, statistical analysis plans, data management plans, CRF builds, external data transfer specifications, dataset specifications, and analysis output requirements
- Experience collaborating with statisticians, clinical programming teams, Data Management, Technology Enabled Science, Standards, study teams, and CROs
- Outstanding written and verbal communication skills
- Strong leadership and organizational skills
- Ability to prioritize individual and team workloads
- Ability to lead and collaborate across cross-functional, global teams
- Experience overseeing vendor deliverables and aligning with internal stakeholders
Benefits:
- Consistent training, development and support
- Significant professional growth opportunities
- Opportunity to work with autonomy and ownership
- Support from Cytel while embedded with a pharmaceutical client
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