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

IQVIA UK

US
Base: $105,800.00 - $294,800.00; bonus/equity: inc...
Fully remote
Statistical analysis plans and reports
Statistical expertise for manufacturing
Guidance and supervision to programmers
The Principal CMC Biostatistician is responsible for providing statistical support for a wide range of activities pertaining to pharmaceutical manufacturing

Job Summary

  • The Principal CMC Biostatistician is responsible for providing statistical support for a wide range of activities pertaining to pharmaceutical manufacturing.
  • Home-based remote working opportunities, work/life balance, and flexible schedules are offered.
  • Collaborate with multi-disciplinary project teams to establish project objectives and timelines in a dynamic, science-focused work environment.

Matching Summary

The Principal CMC Biostatistician is responsible for providing statistical support for a wide range of activities pertaining to pharmaceutical manufacturing.

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 analysis plans and reports
  • Statistical expertise for manufacturing
  • Guidance and supervision to programmers
  • Producing and validating statistical analyses
  • Data integrity reviews
  • Modeling and visualizations of scientific data
  • Support exploratory analyses
  • Compliance with sponsor SOPs and processes

Nice-to-have

  • Design of experiments
  • Bayesian methods
  • Quality by design
  • Building statistical applications

Key Requirements

  • Ph.D. in Statistics or Biostatistics with 5+ years industry experience
  • M.S. in Statistics or Biostatistics with 7+ years industry experience
  • At least 3 years in statistical support of CMC
  • Expertise in R or JMP
  • Understanding of regulatory guidance for drug manufacturing

Work Rights

Not specified

Tailored Resume

Cover Letter