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

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Base: $117,000.00 - $184,200.00; bonus/equity: eli...
Hybrid
Submission data standards planning
Sas programming in clinical trials
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 data traceability, quality assurance, and 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: Comprehensive medical, dental, vision, retirement, paid holidays, vacation, and sick days

Skills & Requirements

Must-have

  • Submission data standards planning
  • SAS programming in clinical trials
  • Regulatory application submissions
  • Statistical programming deliverables
  • Project management skills
  • Technical writing skills

Nice-to-have

  • Experience with Pinnacle 21 Enterprise
  • Knowledge of SOPs and SDLC
  • Cross-cultural collaboration
  • Use of SAS, R, and Python
  • Process improvement initiatives
  • Participation in professional societies

Key Requirements

  • BA/BS plus 5-9 years SAS programming experience
  • MS plus 3-7 years SAS programming experience
  • Experience with US and worldwide regulatory submissions
  • In-depth knowledge of CDISC standards (SDTM, ADaM, CDASH)
  • Proficiency in electronic submission deliverables
  • Ability to work in hybrid model
  • Domestic relocation available
  • Visa sponsorship available

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter