Biostatistician II

Job Summary

To support the development and regulatory approval of diagnostic devices, the full-time Biostatistician II will manage statistical expertise, lead study designs, and collaborate across departments while ensuring high-quality data analyses and reports.

Key Responsibilities

• Lead and execute the design and data analysis of analytical and clinical validation studies for next generation sequencing (NGS)-based diagnostic devices
• Develop innovative biostatistical solutions to complex problems and represent the biostatistics team in cross-functional projects
• Collaborate on study design, planning, and data analysis while maintaining biostatistics quality standards across all deliverables

Required Qualifications

• Master's Degree in Statistics or Biostatistics with 4+ years of experience, or PhD in Statistics or Biostatistics with 2+ years of experience
• Strong programming skills in R
• Experience in clinical study design and statistical methods in diagnostic medicine
• Leadership skills with effective cross-functional partnership abilities
• Understanding of HIPAA and the importance of patient data privacy