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

Mayoly

Rahway, New Jersey, USA
Base: $117,000.00 - $184,200.00; bonus/equity: eli...
Hybrid
Sas programming experience
Cdisc cdash, sdtm, adam
Electronic submission deliverables
Provides oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions

Job Summary

  • Provides oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions.
  • Responsible for continuous improvement of electronic submission processes and providing tools and templates focusing on traceability, quality assurance, data conformance and data fitness.
  • The position is a key collaborator with statistical programming, statistics, regulatory and other project stakeholders.

Matching Summary

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, retirement, paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • SAS programming experience
  • CDISC CDASH, SDTM, ADaM
  • Electronic submission deliverables
  • Regulatory application submission experience
  • Quality assurance and data conformance

Nice-to-have

  • Process improvement initiatives
  • Work across cultures and geographies
  • Clinical data metadata management
  • SAS, R, and Python experience
  • Strategic thinking and tactical execution

Key Requirements

  • BA/BS + 5-9 years SAS programming
  • MS + 3-7 years SAS programming
  • 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