Principal Biostatistician Consultant- 3 Days Hybrid At Malvern Pa

Clinchoice

Malvern, PA, United States
3 days hybrid
Statistical methodology
Regulatory interactions
Clinical trial design
ClinChoice is seeking a Principal Biostatistician Consultant for a hybrid role in Malvern, PA. This position entails leading statistical aspects of drug development, requiring a robust background in biostatistics and experience with regulatory agencies

Job Summary

  • Manage one or more compounds/indications for the entire life cycle, responsible for all statistical aspects of drug development.
  • Provide statistical support for clinical trials from Phase I to IV, including study design, analysis, interpretation, and regulatory submissions.
  • Coordinate statistical and programming support, manage contractors/CROs, and serve as lead statistician for clinical studies.

Matching Summary

Match Score: 85

ClinChoice is seeking a Principal Biostatistician Consultant for a hybrid role in Malvern, PA. This position entails leading statistical aspects of drug development, requiring a robust background in biostatistics and experience with regulatory agencies.

Skills & Requirements

Must-have

  • Statistical methodology
  • Regulatory interactions
  • Clinical trial design
  • Sample size calculations
  • Statistical analysis plan drafting
  • Table, Listing, Figure review

Nice-to-have

  • Client-facing role
  • High-trust environment
  • Process improvement contributions
  • Mentoring entry-level members

Key Requirements

  • M.S. or Ph.D. in Statistics or Biostatistics
  • Minimum 4 years (Ph.D.) or 8 years (M.S.) pharmaceutical industry experience
  • Experience interacting with regulatory agencies
  • Experience managing multiple projects/therapeutic areas
  • Experience managing external vendors

Work Rights

Not specified

Tailored Resume

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