Associate Principal Scientist, Stat. Programming - Sdtm (hybrid)

med-in.at

Base: $142,400.00 - $224,100.00; bonus/equity: eli...
Hybrid
Sas programming in clinical trials
Submission data standards sdtm adam
Statistical programming leadership
The Associate Principal Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions of drug and vaccine clinical development projects

Job Summary

  • The Associate Principal 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 position offers a comprehensive benefits package including medical, dental, vision healthcare, retirement benefits, paid holidays, vacation, and sick days.
  • Employees in office-based U.S. positions will work a hybrid schedule with three days on-site and Fridays remote, effective September 5, 2023.

Matching Summary

The Associate Principal Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions of drug and vaccine clinical development projects.

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • SAS programming in clinical trials
  • Submission data standards SDTM ADaM
  • Statistical programming leadership
  • Regulatory submission deliverables
  • Project management skills
  • Python and SAS technical knowledge
  • Quality assurance of deliverables

Nice-to-have

  • Technical writing skills
  • Process improvement experience
  • Cross-cultural collaboration
  • Mentoring and guidance
  • Experience with Microsoft Project
  • Participation in industry teams
  • Strategic thinking abilities

Key Requirements

  • BA/BS plus 9 years SAS programming experience
  • MS plus 7 years SAS programming experience
  • US and/or worldwide regulatory submission experience
  • Experience with CDISC standards and Define.XML
  • Ability to lead submission deliverable quality assurance
  • Eligible for ERP SPjobs BARDS2020 VETJOBS EBRG

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter