Sr. Scientist, Stat. Programming - Sdtm (hybrid)

MSD (Merck)

Base: $117,000.00 - $184,200.00; bonus/equity: eli...
Hybrid
5 years sas programming experience in clinical trials
Cdisc sdtm and adam submission standards expertise
Experience with fda regulatory application submissions
The Senior Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory applications

Job Summary

  • The Senior Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory applications.
  • The role involves guiding project teams on submission deliverables, utilizing tools like Pinnacle 21 Enterprise, and ensuring data conformance and fitness.
  • Candidates will benefit from a comprehensive package including medical, dental, vision healthcare, retirement benefits, and eligibility for annual bonuses.

Matching Summary

The Senior Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory applications.

Salary

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

Skills & Requirements

Must-have

  • 5 years SAS programming experience in clinical trials
  • CDISC SDTM and ADaM submission standards expertise
  • Experience with FDA regulatory application submissions
  • Pinnacle 21 Enterprise tool proficiency
  • Strong technical writing and stakeholder collaboration skills

Nice-to-have

  • Hands-on experience with R and Python for data analysis
  • Strategic thinking to turn strategy into tactical activities
  • Experience managing global outsource partner programming staff
  • Active participation in professional societies
  • Ability to work across cultures and geographies

Key Requirements

  • BA/BS plus 5 years SAS experience or MS plus 3 years SAS experience
  • US and/or worldwide drug or vaccine regulatory submission experience
  • Demonstrated success in assurance of deliverable quality and process compliance

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter