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Principal Statistical Programmer
Job Summary
A company is looking for a Principal Statistical Programmer, Standards.
Key Responsibilities
- Support the development and maintenance of clinical data standards, including SDTM and ADaM specifications
- Review e-submission packages and provide feedback while ensuring compliance with CDISC and regulatory requirements
- Develop and maintain libraries of CDISC-related metadata and monitor new regulatory requirements related to data standards
Required Qualifications
- Bachelor's degree in computer science, math, statistics, biology, pharmacology, or a related field
- 8+ years of experience as a Statistical Programmer, with recent work on a Global Standards team
- Expert knowledge of SDTM and ADaM data standards and FDA/PMDA/EMA submission requirements
- Experience in therapeutic areas such as Oncology, Virology, and/or Inflammation is preferred
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COMPLETE JOB DESCRIPTION
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