CDISC SME Lead for Clinical Data & Submissions

Cytel; Baton Rouge (LA); On-site; USD 120,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Programmer CDISC SME to lead CDISC standards across clinical studies and regulatory submissions for a global pharmaceutical client in the Baton Rouge area. You will provide expert guidance on SDTM, ADaM, CDASH, and define.xml, ensuring accuracy, traceability and compliance.

This embedded, sponsor-dedicated role emphasizes cross-functional collaboration with statisticians, programmers, Data Management, CROs, and study teams, driving submission readiness and data

Qualifications

• 7+ years of statistical programming in CRO/pharma environments.
• Extensive hands-on experience applying CDISC standards to clinical trial deliverables.
• Expertise in SDTM, ADaM, CDASH, define.xml, and submission expectations.
• Proven experience reviewing CDISC datasets and submission packages.
• Strong understanding of clinical trial documentation and downstream requirements.

Responsibilities

• Provides CDISC SME across studies, submissions, and standards-related activities.
• Performs SME review of datasets, define.xml, and submission packages for accuracy and compliance.
• Serves as a CDISC consultant to study teams, statisticians, programmers, CROs, and stakeholders.
• Collaborates to design data structures for SDTM/ADaM datasets and submission content.
• Leads production, validation, and oversight of programming deliverables for submissions.
• Supports governance, standards documentation, and training materials.

Skills

CDISC SME

SDTM

ADaM

CDASH

Education

Bachelor/Master in Computer Science/Statistics

Tools

SAS

define.xml tooling

Job description

Cytel is seeking a Principal Programmer CDISC SME to lead CDISC standards across clinical studies and regulatory submissions for a global pharmaceutical client in the Baton Rouge area. You will provide expert guidance on SDTM, ADaM, CDASH, and define.xml, ensuring accuracy, traceability and compliance.

This embedded, sponsor-dedicated role emphasizes cross-functional collaboration with statisticians, programmers, Data Management, CROs, and study teams, driving submission readiness and data