Sr. Scientist, Statistical Programmer, Submission Data Standards Quality Management (Hybrid)
MSD(1 month ago)
About this role
A Senior Statistical Programmer in Submission Data Standards Quality Management (SDS QM) within BARDS supports regulatory application submissions for drugs and vaccines by overseeing submission data standards and quality management. The role focuses on improving electronic submission processes and providing tools and templates to ensure traceability, data conformance, and fitness. The position partners with statistical programming, statistics, regulatory and project stakeholders to enable global regulatory interactions and standards adoption.
Required Skills
- SAS
- R
- Python
- SDTM
- ADaM
- CDISC
- Electronic Submissions
- Regulatory Submissions
- Pinnacle 21
- Define.xml
+6 more
Qualifications
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field
- MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field
About MSD
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