Senior CDISC Programmer & Data Standards Lead

Cytel; Madison (WI); On-site; USD 130,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Programmer CDISC SME who will provide subject matter expertise and leadership in applying CDISC standards across clinical studies and regulatory submissions. The role focuses on SDTM, ADaM, CDASH, define.xml, and related deliverables, ensuring alignment with client standards and regulatory expectations.

You will serve as a CDISC consultant to cross-functional teams, review datasets and e-submission packages, and contribute to standardization initiatives and training.

Qualifications

• 7+ years of statistical programming experience in CRO/pharmaceutical environments.
• Extensive hands-on experience applying CDISC standards to trial and regulatory deliverables.
• Proven expertise in SDTM, ADaM, CDASH, define.xml and related submission documentation.

Responsibilities

• Provide CDISC SME leadership across studies, submissions, and standards activities.
• Perform SME review of datasets, annotated CRFs, define.xml, Reviewer’s Guides, and e-submission packages.
• Serve as CDISC consultant to study teams, statisticians, programmers, Data Management, CROs, and other stakeholders.
• Collaborate with statisticians and programming to design data structures for SDTM/ADaM datasets and analysis content.
• Lead or contribute to production, validation, and oversight of programming deliverables for submissions.
• Support CDISC and client standards governance and create training materials.

Skills

CDISC standards

SDTM/ADaM/CDASH

clinical programming

leadership

communication

mentorship

Education

BSc/MSc/Diploma in Computer Science or Statistics

Tools

SAS

Job description

Cytel is seeking a Principal Programmer CDISC SME who will provide subject matter expertise and leadership in applying CDISC standards across clinical studies and regulatory submissions. The role focuses on SDTM, ADaM, CDASH, define.xml, and related deliverables, ensuring alignment with client standards and regulatory expectations.

You will serve as a CDISC consultant to cross-functional teams, review datasets and e-submission packages, and contribute to standardization initiatives and training.