Job description
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Programmer CDISC SME you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview:
The Principal Programmer CDISC SME provides subject matter expertise and leadership in the application, review, and oversight of CDISC standards across clinical studies and regulatory submission activities.
This role ensures that clinical data standards, including SDTM, ADaM, CDASH, define.xml, annotated CRFs, Reviewer’s Guides, and related submission deliverables, are implemented consistently, accurately, and in alignment with client standards, regulatory expectations, and industry best practices.
The role serves as a key CDISC consultant to study teams, statisticians, programmers, Data Management, Technology Enabled Science, Standards, CROs, and other cross-functional stakeholders. The position provides expert review of CDISC-based datasets and documentation, supports standardization initiatives, contributes to process documentation and training, and ensures submission readiness of clinical data packages.
Originally posted on Himalayas
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.