Biostatistician I

Job Summary

To support the development and regulatory approval of diagnostic devices, the full-time Biostatistician I will provide statistical expertise, manage study designs, conduct analyses, and collaborate with cross-functional teams while working remotely.

Key Responsibilities:

• Contribute to the design and analysis of clinical validation studies for next generation sequencing (NGS)-based diagnostic devices
• Support innovative biostatistical solutions to complex problems and collaborate on study design and data presentation
• Maintain biostatistics quality standards and ensure timely completion of analyses and deliverables

Required Qualifications:

• Master's Degree in Statistics or Biostatistics with 2+ years of experience, or a PhD in Statistics or Biostatistics
• Strong programming skills in R
• Experience in clinical study design and statistical methods in diagnostic medicine
• Knowledge of clinical and analytical validation of medical diagnostic devices
• Understanding of HIPAA and patient data privacy