Biostatistician I

The role focuses on delivering statistical expertise for developing and validating cancer diagnostic devices. The biostatistician will design studies, analyze data, and prepare regulatory submissions for next-generation sequencing (NGS)-based cancer tests.

Key Responsibilities

• Execute design and analysis of validation studies for NGS-based diagnostic tests
• Develop statistical models and study protocols
• Collaborate across departments on study design and data analysis
• Contribute to regulatory submissions and respond to FDA inquiries
• Maintain quality standards and meet project deadlines
• Support internal teams with statistical guidance

Required Qualifications

• Master's degree in Statistics, Biostatistics, or Computational Biology plus 2+ years experience, OR PhD in related field
• Strong programming skills in R and Python

Preferred Qualifications

• PhD in quantitative field
• Industry, academic, or FDA experience as biostatistician
• Machine learning and deep learning expertise
• NGS and cancer genomics knowledge
• Medical device validation experience
• HIPAA understanding
• Strong communication and presentation abilities