CDISC Standards Subject Matter Expert
Job Summary
Providing hands-on expertise for CDISC standards, the full-time CDISC & eSubmission Standards Subject Matter Expert will support the implementation of internal standards, conduct quality reviews of deliverables from CRO partners, and ensure clinical data packages meet inspection-readiness criteria in a hybrid/remote work environment.
Key responsibilities:
- Develop and maintain internal CDISC and submission standards, templates, and SOPs for SDTM, ADaM, Define-XML, and Reviewer's Guides
- Ensure compliance with defined SDTM and ADaM versions and assist study teams with standards exceptions
- Conduct quality reviews of CRO-provided SDTM, ADaM, Define-XML, and submission data packages
Required qualifications:
- Bachelor's degree in Life Sciences, Statistics, Computer Science, Data Science, or a related field
- 8+ years of relevant pharmaceutical or biotechnology industry experience
- 2-3 years of previous experience working as a CDISC SME
- Hands-on experience with Pinnacle 21 Community/Enterprise
- Strong knowledge of CDISC standards (SDTM, ADaM) and data traceability
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