Senior Biostatistician

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, 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