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

Memorialdrivevetclinic

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 role includes coaching project teams, continuous improvement of electronic submission processes, and collaboration with statistical programming, statistics, regulatory, and other project stakeholders to ensure timely and high-quality deliverables.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, and supports a hybrid work model with three days on-site per week.

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
  • Hybrid work model

Nice-to-have

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

Key Requirements

  • BA/BS or MS in relevant field
  • 7+ to 9+ years SAS programming experience
  • US and/or worldwide regulatory submission experience
  • Experience with CDISC standards and Define.XML
  • Leadership in regulatory application submissions
  • Ability to work in hybrid model
  • Visa sponsorship available

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter