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

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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 benefit from a comprehensive package including medical, dental, vision insurance, retirement plans, paid holidays, vacation, and sick days.

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 and ADaM
  • Statistical programming leadership
  • Regulatory submission deliverables
  • Project management skills
  • Python and SAS technical knowledge
  • Electronic submission process improvement

Nice-to-have

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

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
  • Leadership level in regulatory submissions
  • Ability to work in a hybrid model
  • VISA sponsorship available

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter