Biostatistician II

The role involves delivering statistical expertise for developing and validating cancer diagnostic devices. The biostatistician will design studies, perform data analyses, write reports, and collaborate across teams to support regulatory submissions and scientific publications related to next-generation sequencing diagnostic tests.

Key Responsibilities

• Lead design and analysis of validation studies for NGS-based cancer diagnostic tests
• Create statistical solutions for complex problems
• Represent biostatistics within cross-functional projects
• Contribute to regulatory submissions and respond to FDA review questions
• Maintain quality standards and meet project timelines
• Provide statistical interpretation to the broader business

Required Qualifications

• Master's degree in Statistics/Biostatistics (4+ years experience) OR PhD in related field (2+ years)
• Strong R programming skills

Preferred Qualifications

• PhD with industry, academic, or FDA biostatistics experience
• Medical device validation expertise
• Proficiency in R and Python
• Cancer genetics and genomics knowledge
• NGS and genomic data analysis experience
• Leadership, communication, and writing skills
• HIPAA and data privacy understanding