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Merck Sharp & Dohme Corp is seeking a Senior Scientist, Statistical Programmer for Submission Data Standards Quality Management in a hybrid work environment. The role involves oversight and quality management of submission data standards for drug and vaccine regulatory applications, requiring strong technical skills and collaborative abilities.
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Job Summary
The Senior Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions.
Responsibilities include submission data standards planning, coaching project teams, and keeping current with industry submission data standards like SDTM and ADaM.
The role involves continuous improvement of the electronic submission process, providing tools and templates focusing on traceability, quality assurance, data conformance, and data fitness.
Matching Summary
Match Score: 75
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Merck Sharp & Dohme Corp is seeking a Senior Scientist, Statistical Programmer for Submission Data Standards Quality Management in a hybrid work environment. The role involves oversight and quality management of submission data standards for drug and vaccine regulatory applications, requiring strong technical skills and collaborative abilities.
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Salary
Base: $117,000.00 - $184,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, 401(k), paid holidays, vacation, sick days
Skills & Requirements
Must-have
SAS programming experience
CDISC SDTM and ADaM implementation
Regulatory application submission experience
Electronic submission deliverables development
Quality assurance and process compliance
Nice-to-have
Continuous improvement of electronic submission process
Stakeholder relationship management
Strategic thinking and tactical execution
Cross-cultural and cross-geographical work
Key Requirements
BA/BS plus 5-9 years SAS programming experience
MS plus 3-7 years SAS programming experience
US and/or worldwide drug or vaccine regulatory application submission experience
In-depth knowledge of CDISC standards (SDTM, ADaM)