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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