Principal CDISC Programmer – Data Standards Leader

Cytel; Jefferson City (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Programmer CDISC SME to lead CDISC standard adoption across clinical studies and regulatory submissions. You will review datasets, define.xml, and submission packages ensuring accuracy, traceability, and compliance with client expectations.

You will mentor colleagues, collaborate with statisticians, CROs, and Data Management to shape study data structures and submission content, driving quality and efficiency.

Qualifications

• Degree (BSc/MSc) in Computer Science, Mathematics/Statistics, or related area.
• 7+ years of statistical programming experience in CRO/pharmaceutical environments.
• Extensive hands-on CDISC standards application to trial and submissions.

Responsibilities

• Provide SME leadership in CDISC standards across studies and submissions.
• Review CDISC datasets, define.xml, annotated CRFs, and submission content for accuracy.
• Guide study setup, data standards interpretation, and submission readiness.
• Collaborate with statisticians, programmers, and CROs to design data structures.
• Mentor programmers and train cross-functional teams on CDISC standards.

Skills

CDISC standards

SDTM

ADaM

CDASH

define.xml

Regulatory submissions

Leadership

Communication

Mentorship

Education

BSc/MSc in Computer Science or Statistics

Tools

SAS

CDISC tools

Job description

Cytel is seeking a Principal Programmer CDISC SME to lead CDISC standard adoption across clinical studies and regulatory submissions. You will review datasets, define.xml, and submission packages ensuring accuracy, traceability, and compliance with client expectations.

You will mentor colleagues, collaborate with statisticians, CROs, and Data Management to shape study data structures and submission content, driving quality and efficiency.