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Senior Regulatory Biostatistician

7/24/2025

No location specified

Job Summary

A company is looking for a Senior Quality/Regulatory Biostatistician to support statistical work in Quality with a focus on regulatory submissions and clinical trial planning.

Key Responsibilities
  • Provide statistical expertise for regulatory submissions and analyze data to identify trends and drive corrective actions
  • Design and implement statistical methods for quality monitoring and collaborate on clinical trial protocols
  • Ensure compliance with global regulatory requirements and contribute to internal audits and inspections
Required Qualifications
  • Master's or PhD in Biostatistics, Statistics, or a related field
  • Minimum of 5 years of experience in a regulated healthcare environment
  • Experience supporting regulatory submissions with statistical content
  • Proficiency in statistical software such as SAS, R, or STATA
  • Strong understanding of FDA, ICH, and ISO statistical requirements

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