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

Newyorkbioconnect

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 applications 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 applications 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 plans, 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 applications 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 of deliverables

Nice-to-have

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

Key Requirements

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

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter