Remote Late Phase Rare Diseases Trials Principal Biostatistician

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Tue, Jan 05, 2021

This job expires in: 18 days

Job Category: Information Technology

Remote Level: 100% Remote

Employer Type: Employer

Career Level: Experienced

Education Level: Doctorate

Job Summary

A contract research organization and statistical software developer has a current position open for a Remote Late Phase Rare Diseases Trials Principal Biostatistician.

Must be able to:

  • Provide statistical input into study protocols, Case Report Forms, etc
  • Provide statistical output as required for manuscripts
  • Contribute to the development of sourcing strategy for projects

Position Requirements Include:

  • Masters in a statistical field required
  • 7 years of Statistical experience in the Pharmaceutical/Biotechnology industry
  • Knowledge of relevant international regulatory guidelines applicable to clinical development,
  • Some experience of regulatory interactions and data e-submission to FDA
  • Study lead experience working with cross-functional teams
  • Experience in sample size calculation, protocol concept development, protocol development

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