Fsp Principal Biostatistician, Safety Analytics

IQVIA Inc

United States
Base: $105,800.00 - $294,800.00; bonus/equity: not...
Fully remote
Adam/tfl standard development
Safety analysis support
Ich gcp, ich e9 knowledge
This role provides statistical support for Phase 1, 2 and 3 pharmaceutical clinical trials, focusing on safety endpoints and outcomes

Job Summary

  • This role provides statistical support for Phase 1, 2 and 3 pharmaceutical clinical trials, focusing on safety endpoints and outcomes.
  • You will collaborate with multi-disciplinary project teams, contribute to clinical study reports and regulatory documents, and serve as an unblinded DMC statistician.
  • Benefits include home-based remote working, work/life balance, flexible schedules, technical training, and promising career trajectory.

Matching Summary

This role provides statistical support for Phase 1, 2 and 3 pharmaceutical clinical trials, focusing on safety endpoints and outcomes.

Salary

Base: $105,800.00 - $294,800.00; Bonus/Equity: Not specified; Benefits: Health and welfare and/or other benefits

Skills & Requirements

Must-have

  • ADaM/TFL standard development
  • Safety analysis support
  • ICH GCP, ICH E9 knowledge
  • CDISC SDTM, ADAM, CDASH experience
  • R/SAS programming skills

Nice-to-have

  • Lead DSBM or DMC
  • Pro-active and independent work
  • Constructive programmer management
  • Fast-paced environment

Key Requirements

  • PhD in Statistics/Biostatistics with 5+ years industry experience
  • MS in Statistics/Biostatistics with 7+ years industry experience
  • 5+ years Phase 1, 2, 3 clinical trial experience
  • Strong ADaM datasets and TFL review experience
  • Ability to investigate and troubleshoot output mismatches

Work Rights

Not specified

Tailored Resume

Cover Letter