🚀 Senior Biostatistician

Key Responsibilities

• Develop and implement statistical analysis plans for IVD development, verification, and validation studies
• Collaborate with cross-functional teams to design study protocols, including sample size calculations and power analyses
• Perform advanced statistical analyses and manage automated reporting pipelines for regulatory compliance

Required Qualifications

• PhD or Master's degree in Biostatistics, Statistics, or related field, or equivalent professional experience
• 7+ years of experience in biostatistics, focusing on analytical development and validation studies for IVD devices
• Proven ability to develop validated scripts and maintain reproducible analytical workflows
• Experience with version-controlled statistical codebases (Git) and automated reporting pipelines using tools like R Markdown
• Strong understanding of regulatory guidelines for diagnostic product development