Principal CDISC Programmer & Standards Lead

Cytel; Richmond (VA); On-site; USD 120,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Programmer CDISC SME to provide subject matter leadership in applying and overseeing CDISC standards across clinical studies and regulatory submissions. You will ensure SDTM, ADaM, CDASH, and define.xml are implemented consistently and align with regulatory expectations.

The role requires extensive CDISC experience, strong cross-functional collaboration, and ability to mentor teams including CROs.

Qualifications

• 7+ years of statistical programming in CRO/pharmaceutical environments.
• Extensive hands-on experience applying CDISC standards to clinical trial deliverables.
• Expertise in SDTM, ADaM, CDASH, define.xml, annotated CRFs, Reviewer’s Guides, regulatory submission expectations.
• Proven experience reviewing, specifying, producing, validating CDISC-compliant datasets and submission packages.
• Strong understanding of clinical trial documentation and downstream programming requirements.
• Experience collaborating with statisticians, programming teams, Data Management and CROs.
• Excellent communication and leadership skills.
• Ability to lead cross-functional, global teams and oversee vendor deliverables.

Responsibilities

• Provide CDISC SME leadership across studies, submissions, and standards activities.
• Review datasets, define.xml, and submission packages for accuracy and regulatory compliance.
• Serve as CDISC consultant to study teams and CROs with guidance on data standards and submission readiness.
• Design data structures for SDTM/ADaM datasets and related deliverables.
• Lead or contribute to programming deliverables ensuring quality and traceability for submissions.
• Support governance and training on CDISC standards and templates.

Skills

CDISC standards

SDTM/ADaM

CDASH/define.xml

Leadership

Regulatory knowledge

Cross-functional

Education

BSc/MSc/Diploma in CS/Math/Stats

Tools

SAS

Define.xml tooling

CDISC tooling

Job description

Cytel is seeking a Principal Programmer CDISC SME to provide subject matter leadership in applying and overseeing CDISC standards across clinical studies and regulatory submissions. You will ensure SDTM, ADaM, CDASH, and define.xml are implemented consistently and align with regulatory expectations.

The role requires extensive CDISC experience, strong cross-functional collaboration, and ability to mentor teams including CROs.