Biostatistician II

Job Summary

To support the development and regulatory approval of diagnostic devices, the full-time Biostatistician II will provide statistical expertise, manage study designs and analyses, and collaborate across departments while working remotely.

Key Responsibilities

• Lead the design and data analysis of analytical and clinical validation studies for next generation sequencing-based diagnostic devices
• Develop innovative biostatistical solutions and collaborate with cross-functional teams on study planning and data presentation
• Contribute to regulatory submissions and maintain biostatistics quality standards across all study 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
• Demonstrated ability to manage multiple projects and meet deadlines
• Understanding of HIPAA and the importance of patient data privacy