Remote Principal Senior Rare Diseases Biostatistician in Hopewell

Location: New Jersey

Compensation: To Be Discussed

Staff Reviewed: Tue, Dec 22, 2020

This job expires in: 4 days

Job Category: Healthcare

Remote Level: 100% Remote

Employer Type: Employer

Career Level: Experienced

Education Level: Doctorate

Job Summary

A contract research organization and statistical software developer is filling a position for a Remote Principal Senior Rare Diseases Biostatistician in Hopewell.

Core Responsibilities Include:

  • Provide statistical input into study protocols, Case Report Forms, and data management plans
  • Provide statistical output as required for manuscripts
  • Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers

Position Requirements Include:

  • Master's in Statistics, Biostatistics or related discipline; will consider PhD level candidates
  • 7 years of experience as biostatistician in the Pharmaceutical/Biotechnology industry in clinical development (5 years with PhD)
  • Knowledge of relevant international regulatory guidelines applicable to clinical development
  • Some experience of regulatory interactions and data e-submission to FDA
  • Fluent in English
  • Working SAS & CDISC knowledge

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