Fsp Principal Biostatistician - Chemistry, Manufacture And Control (cmc)

IQVIA

Durham, United States
Base: $105,800.00 - $294,800.00; bonus/equity: inc...
Fully remote
Statistical support for pharmaceutical manufacturing
Statistical analysis plans and reports
Statistical expertise for engineers and scientists
The Principal CMC Biostatistician will provide statistical support for pharmaceutical manufacturing activities, including planning and analysis of experiments, co-authoring plans and reports, and collaborating with multi-disciplinary teams

Job Summary

  • The Principal CMC Biostatistician will provide statistical support for pharmaceutical manufacturing activities, including planning and analysis of experiments, co-authoring plans and reports, and collaborating with multi-disciplinary teams.
  • This role offers remote working opportunities in the U.S. or Canada, emphasizing work-life balance, flexible schedules, and collaboration with motivated teams.
  • Key responsibilities include providing statistical expertise, guiding programmers, producing and validating analyses for regulatory submissions, conducting data integrity reviews, and supporting exploratory analyses.

Matching Summary

The Principal CMC Biostatistician will provide statistical support for pharmaceutical manufacturing activities, including planning and analysis of experiments, co-authoring plans and reports, and collaborating with multi-disciplinary teams.

Salary

Base: $105,800.00 - $294,800.00; Bonus/Equity: Incentive plans, bonuses may be offered; Benefits: Range of health and welfare and/or other benefits

Skills & Requirements

Must-have

  • statistical support for pharmaceutical manufacturing
  • statistical analysis plans and reports
  • statistical expertise for engineers and scientists
  • analysis dataset specifications
  • producing and validating statistical analyses
  • regulatory submission experience
  • data integrity reviews
  • modeling and visualizations of scientific data

Nice-to-have

  • work-life balance and flexible schedules
  • motivated, high-performance teams
  • technical training and tailored development
  • research opportunities
  • promising career trajectory
  • job stability and long-term engagements
  • engaging, fast-paced environment

Key Requirements

  • Ph.D. in Statistics, Biostatistics, or related field with 5+ years industry experience
  • M.S. in Statistics, Biostatistics, or related field with 7+ years industry experience
  • At least 3 years in statistical support of CMC
  • Demonstrated ability to work proactively and independently
  • Effective communication of statistical concepts
  • Expertise in R or JMP
  • Understanding of regulatory guidance for drug manufacturing

Work Rights

Not specified

Tailored Resume

Cover Letter