CDISC Standards Subject Matter Expert
Job Summary
Providing hands-on expertise for CDISC standards, the hybrid/remote CDISC & eSubmission Standards Subject Matter Expert will manage the development and maintenance of internal standards, conduct quality reviews of deliverables, and ensure compliance with regulatory submission requirements.
Key responsibilities
- Contribute to the development and maintenance of internal CDISC and submission standards, templates, and SOPs
- Ensure study-level compliance with SDTM and ADaM versions and assist study teams with standards exceptions
- Conduct quality reviews of CRO-provided SDTM, ADaM, and submission data packages, and support NDA/BLA submissions
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 as a CDISC SME
- Hands-on experience with Pinnacle 21 Community/Enterprise
- Strong understanding of CDISC standards (SDTM, ADaM) and data traceability
Complete Job Description
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