Senior Regulatory Biostatistician

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