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

leHACK

Base: $142,400.00 - $224,100.00; bonus/equity: eli...
Hybrid
Sas programming in clinical trials
Submission data standards sdtm and 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 involves collaboration with statistical programming, statistics, regulatory, and other project stakeholders to ensure efficient execution of project plans with timely and high-quality deliverables.
  • Employees work under a U.S. Hybrid Work Model with three days on-site per week and are eligible for a comprehensive benefits package including medical, dental, vision, retirement, paid holidays, and vacation.

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

Skills & Requirements

Must-have

  • SAS programming in clinical trials
  • Submission data standards SDTM and ADaM
  • Statistical programming leadership
  • Regulatory submission deliverables
  • Python and SAS technical skills
  • Project management skills
  • Electronic submission process improvement

Nice-to-have

  • Technical writing skills
  • Mentoring and guidance experience
  • Experience with Microsoft Project
  • Cross-cultural collaboration
  • Process improvement expertise
  • Participation in industry conferences

Key Requirements

  • BA/BS plus 9 years SAS programming experience
  • MS plus 7 years SAS programming experience
  • Experience in US and/or worldwide regulatory submissions
  • Knowledge of CDISC standards including SDTM, ADaM, Define.XML
  • Strong project management and leadership skills
  • Ability to work with global outsource partners
  • Visa sponsorship available

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter