Senior Biostatistician

Job Summary

A company is looking for a Senior Biostatistician to join their product development team focused on early cancer detection.

Key Responsibilities

• Develop and implement statistical analysis plans for IVD development and Analytical Validation studies
• Collaborate with cross-functional teams to design study protocols and perform advanced statistical analyses
• Build and manage automated reporting pipelines and contribute to regulatory submissions

Required Qualifications

• PhD 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
• Experience drafting Statistical Analysis Plans for regulated studies
• Proven ability to develop validated scripts and maintain reproducible analytical workflows
• Strong understanding of regulatory guidelines for diagnostic product development