Biostatisticien Principal Fsp - Développement Clinique Précoce (pk)

IQVIA

United States
Base: $126,800.00 - $235,400.00 annualized; bonus/...
Fully remote
Sas proficiency for statistical analysis
Non-compartmental pk endpoint analysis
Cdisc standards (sdtm, adam, cdash)
The Principal Biostatistician provides statistical support for drug development programs in early phases, focusing on healthy subject studies with PK and PD endpoints

Job Summary

  • The Principal Biostatistician provides statistical support for drug development programs in early phases, focusing on healthy subject studies with PK and PD endpoints.
  • Responsibilities include writing statistical sections of protocols, reviewing eCRFs, creating randomization specifications, and supervising programmers for data analysis.
  • The role offers home-based remote working opportunities within the US or Canada, along with a focus on bringing new therapies to market rather than budget constraints.

Matching Summary

The Principal Biostatistician provides statistical support for drug development programs in early phases, focusing on healthy subject studies with PK and PD endpoints.

Salary

Base: $126,800.00 - $235,400.00 annualized; Bonus/Equity: Not specified; Benefits: Health, wellness, and other benefits included

Skills & Requirements

Must-have

  • SAS proficiency for statistical analysis
  • Non-compartmental PK endpoint analysis
  • CDISC standards (SDTM, ADaM, CDASH)
  • ICH GCP regulatory compliance knowledge
  • Clinical trial protocol and SAP authoring

Nice-to-have

  • Experience with statistical modeling and simulations
  • Background in pharmacodynamic analyses
  • Ability to work independently on projects
  • Constructive programmer management skills

Key Requirements

  • PhD in Statistics/Biostatistics with 3+ years industry experience
  • MS in Statistics/Biostatistics with 5+ years industry experience
  • 2+ years experience in non-compartmental PK analysis
  • Proficiency in SAS and R for inferential analyses

Work Rights

Not specified

Tailored Resume

Cover Letter