Fsp Principal Biostatistician, Safety Analytics

IQVIA

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

Job Summary

  • The Principal Biostatistician will provide statistical support for Phase 1, 2 and 3 pharmaceutical clinical trials, focusing on safety endpoints and outcomes.
  • This role offers home-based remote working opportunities, work/life balance, flexible schedules, and opportunities for technical training and career development.
  • Responsibilities include supporting safety analytics, developing statistical analysis plans, contributing to regulatory documents, and serving as an unblinded DMC statistician.

Matching Summary

The Principal Biostatistician will provide 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: Not specified

Skills & Requirements

Must-have

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

Nice-to-have

  • Motivated, high-performance teams
  • Promising career trajectory
  • Engaging, fast-paced environment
  • Leading DSBM or DMC

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter