Senior CDISC SME Programmer — Submissions Lead

Cytel; Trenton (NJ); On-site; USD 120,000 - 170,000; Full time

Job summary

Cytel Inc. invites applications for a Principal Programmer CDISC SME dedicated to one global pharmaceutical client, supporting CDISC standards in SDTM/ADaM across studies and submissions.

You will provide SME guidance, review datasets, define.xml, annotated CRFs, and work with statisticians, programmers, data management, and CROs to ensure submission readiness.

The role emphasizes mentorship, standards governance, and cross-functional collaboration within Cytel's embedded model.

Qualifications

• CDISC standards, SDTM/ADaM, define.xml
• CDISC governance and regulatory submission readiness
• Strong leadership and cross-functional collaboration

Responsibilities

• Provide CDISC SME leadership across SDTM/ADaM datasets and submission packages.
• Review datasets, define.xml, annotated CRFs, and Reviewer’s Guides for accuracy and compliance.
• Collaborate with statisticians, programmers, Data Management, CROs to design data structures and submissions.
• Mentor and train team members on CDISC standards and client expectations.

Job description

Cytel Inc. invites applications for a Principal Programmer CDISC SME dedicated to one global pharmaceutical client, supporting CDISC standards in SDTM/ADaM across studies and submissions.

You will provide SME guidance, review datasets, define.xml, annotated CRFs, and work with statisticians, programmers, data management, and CROs to ensure submission readiness.

The role emphasizes mentorship, standards governance, and cross-functional collaboration within Cytel's embedded model.