Biostatisticien(ne) Principal(e) Fsp, Phase Tardive

IQVIA Inc

United States
Base: $110,400.00 - $221,500.00 annualized; bonus/...
Fully remote
Sas and/or r programming expertise
Cdisc standards sdtm adam cdash
Ich and fda regulatory guidance knowledge
IQVIA is seeking a Senior Biostatistician for a fully remote position to provide statistical support for late-phase drug development programs. The ideal candidate should have a PhD or MS in a relevant field, with extensive experience in biostatistics and familiarity with regulatory guidelines

Job Summary

  • The Senior Biostatistician provides critical statistical support for Phase 2 or 3 drug development programs focusing on efficacy and safety endpoints.
  • This role offers a Functional Service Provider partnership allowing collaboration with world-class pharmaceutical sponsors while utilizing their systems.
  • Candidates will manage project timelines, supervise programmers, and contribute to regulatory documents including NDAs and clinical study reports.

Matching Summary

Match Score: 85

IQVIA is seeking a Senior Biostatistician for a fully remote position to provide statistical support for late-phase drug development programs. The ideal candidate should have a PhD or MS in a relevant field, with extensive experience in biostatistics and familiarity with regulatory guidelines.

Salary

Base: $110,400.00 - $221,500.00 annualized; Bonus/Equity: Incentive plans and bonuses may be offered; Benefits: Health, wellness, and other benefits included

Skills & Requirements

Must-have

  • SAS and/or R programming expertise
  • CDISC standards SDTM ADaM CDASH
  • ICH and FDA regulatory guidance knowledge
  • Clinical trial protocol and SAP authoring
  • NDA submission experience

Nice-to-have

  • Experience with simulations and biomarker analyses
  • Multivariate analysis capabilities
  • Production programming of statistical outputs
  • Estimand framework knowledge
  • Cross-therapeutic area experience

Key Requirements

  • PhD in Statistics/Biostatistics with 3+ years industry experience
  • MS in Statistics/Biostatistics with 5+ years industry experience
  • Demonstrated ability to work independently and manage projects

Work Rights

Not specified

Tailored Resume

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