Sr. Scientist, Statistical Programmer, Submission Data Standards Quality Management (hybrid)

539

Base: $117,000.00 - $184,200.00; bonus/equity: eli...
Hybrid
Sas programming in clinical trials
Submission data standards expertise
Regulatory application submissions
The Senior 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 Senior 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 traceability, quality assurance, and data conformance.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, and sick days.

Matching Summary

The Senior 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: $117,000.00 - $184,200.00; 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 expertise
  • Regulatory application submissions
  • Statistical programming deliverables
  • Project management skills
  • Quality assurance and process compliance
  • Stakeholder collaboration

Nice-to-have

  • Experience with R and Python
  • Knowledge of SOPs and SDLC
  • Cross-cultural collaboration
  • Clinical data metadata management
  • Process improvement initiatives
  • Technical writing skills
  • Participation in professional societies

Key Requirements

  • BA/BS or MS in related field
  • 3-9 years SAS programming experience
  • US and/or worldwide regulatory submission experience
  • In-depth knowledge of CDISC standards
  • Ability to lead projects independently
  • Experience with electronic submission deliverables
  • US work authorization required

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter