Senior CDISC Programmer - SDTM/ADaM SME

Cytel; Tallahassee (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Programmer CDISC SME to provide subject matter expertise and leadership across CDISC standards for clinical studies and regulatory submissions. You will review datasets, define.xml, annotated CRFs, and submission packages to ensure accuracy and regulatory alignment.

You will mentor teams, collaborate with statisticians, programmers, Data Management, CROs, and other stakeholders, and help drive standardization and training programs globally.

Qualifications

• Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area.
• Extensive hands-on experience applying CDISC standards to clinical trial and regulatory submission deliverables.
• Demonstrated expertise in CDISC standards (SDTM, ADaM, CDASH, define.xml, annotated CRFs, Reviewer’s Guides).
• Proven experience reviewing, specifying, producing, validating, or overseeing CDISC-compliant datasets and submission packages.
• Strong understanding of clinical trial documentation and downstream programming requirements.
• Experience collaborating with statisticians, clinical programming teams, Data Management, CROs, and cross-functional partners.
• Outstanding communication and leadership skills.
• Excellent organizational skills and ability to prioritize workloads.
• Ability to lead and collaborate across global teams including vendor oversight.

Responsibilities

• Provides CDISC subject matter expertise across clinical studies, submissions, and standards-related activities.
• Performs SME review of datasets, annotated CRFs, define.xml, and e-submission packages.
• Serves as a CDISC consultant to study teams and CROs on data standards and submission readiness.
• Designs data structures and specifications for SDTM and ADaM datasets and analyses.
• Leads or contributes to production, validation, review, and oversight of programming deliverables.
• Supports CDISC and client standards governance and training materials.
• Mentors and trains programmers and cross-functional stakeholders on CDISC standards.
• Identifies process gaps and helps develop global tools to improve efficiency and quality.

Skills

CDISC SME

Leadership

Regulatory submission

Clinical data standards

Cross-functional collaboration

Education

BSc/MSc/Diploma in CS/Math/Stats

Job description

Cytel is seeking a Principal Programmer CDISC SME to provide subject matter expertise and leadership across CDISC standards for clinical studies and regulatory submissions. You will review datasets, define.xml, annotated CRFs, and submission packages to ensure accuracy and regulatory alignment.

You will mentor teams, collaborate with statisticians, programmers, Data Management, CROs, and other stakeholders, and help drive standardization and training programs globally.