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

MOBS Lab

Rahway, NJ, USA
Base: $117,000.00 - $184,200.00; bonus/equity: eli...
Hybrid
Sas programming experience
Sdtm and adam standards
Regulatory application submission
The Senior Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions

Job Summary

  • The Senior Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions.
  • Accountability includes submission data standards planning, coaching project teams, outreach to external vendors, and staying current with industry submission data standards.
  • The position is responsible for continuous improvement of the electronic submission process, providing tools and templates focusing on traceability, quality assurance, data conformance, and data fitness.

Matching Summary

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

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
  • SDTM and ADaM standards
  • regulatory application submission
  • electronic submission deliverables
  • quality assurance and data conformance

Nice-to-have

  • process improvement initiatives
  • cross-cultural collaboration
  • strategic thinking and tactical execution
  • working across geographies

Key Requirements

  • 5-9 years SAS programming experience (BA/BS)
  • 3-7 years SAS programming experience (MS)
  • US and/or worldwide regulatory submission experience
  • In-depth knowledge of CDISC standards
  • Proficiency in diverse data collection methods

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter