Sr. Scientist, Statistical Programmer, Submission Data Standards Quality Management (hybrid)

Merck Sharp & Dohme Corp

Multiple Locations, US
Base: $117,000.00 - $184,200.00; bonus/equity: ann...
Hybrid (3 days onsite, 1 day remote)
5-9 years sas programming experience in clinical trials
In-depth knowledge of cdisc sdtm and adam standards
Experience with us or worldwide drug regulatory submissions
Merck Sharp & Dohme Corp is seeking a Sr. Scientist, Statistical Programmer for their Submission Data Standards Quality Management team. The role involves oversight of submission data standards for regulatory applications within a hybrid work environment, requiring extensive experience in SAS programming and regulatory submissions

Job Summary

  • The Senior Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions of drug and vaccine clinical development projects.
  • The incumbent will be responsible for continuous improvement of the electronic submission process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance, and data fitness.
  • The successful candidate will be eligible for an annual bonus, long-term incentive, and a comprehensive package of benefits including medical, dental, vision, and retirement plans.

Matching Summary

Match Score: 85

Merck Sharp & Dohme Corp is seeking a Sr. Scientist, Statistical Programmer for their Submission Data Standards Quality Management team. The role involves oversight of submission data standards for regulatory applications within a hybrid work environment, requiring extensive experience in SAS programming and regulatory submissions.

Salary

Base: $117,000.00 - $184,200.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 5-9 years SAS programming experience in clinical trials
  • In-depth knowledge of CDISC SDTM and ADaM standards
  • Experience with US or worldwide drug regulatory submissions
  • Proficiency in Pinnacle 21 Enterprise Up-versioning activities
  • Ability to guide project teams on submission deliverables

Nice-to-have

  • Experience using R and Python for data-driven insights
  • Knowledge of clinical data metadata platforms
  • Active participation in professional societies
  • Experience leading process improvement initiatives
  • Ability to work across cultures and geographies

Key Requirements

  • BA/BS plus 5-9 years SAS experience OR MS plus 3-7 years SAS experience
  • Direct experience implementing industry clinical data standards (CDISC)
  • US and/or worldwide drug or vaccine regulatory application submission experience

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter