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

Muckelab

Base: $142,400.00 - $224,100.00; bonus/equity: eli...
Hybrid
Statistical programming
Submission data standards
Sas programming experience
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 supports continuous improvement of electronic submission processes and collaborates with statistical programming, statistics, regulatory, and other project stakeholders to ensure efficient execution and high-quality deliverables.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, and sick days, and supports a hybrid work model in the U.S.

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

  • Statistical programming
  • Submission data standards
  • SAS programming experience
  • Python programming
  • Regulatory submission deliverables
  • Project management skills
  • CDISC standards (SDTM, ADaM)

Nice-to-have

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

Key Requirements

  • BA/BS plus 9 years SAS programming
  • MS plus 7 years SAS programming
  • Experience with US and worldwide regulatory submissions
  • Experience with CDISC submission standards
  • Leadership experience in regulatory submissions
  • Ability to work in hybrid model
  • Visa sponsorship available

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter