Clinical Biostatistician Consultant

Job Summary

To support clinical studies involving medical devices, the part-time Clinical Biostatistician Consultant will develop statistical analysis plans, perform statistical analyses using SAS and/or R, and collaborate with cross-functional teams to ensure compliance with FDA regulations.

Key responsibilities

• Develop Statistical Analysis Plans (SAPs) for clinical studies
• Perform statistical analyses and conduct sample size and power calculations
• Prepare statistical sections of clinical study reports and regulatory documents

Required qualifications

• Master's degree in Biostatistics, Statistics, Epidemiology, or a related field
• 3-5 years of clinical biostatistics experience
• Experience supporting clinical studies in the medical device, biotechnology, or pharmaceutical industry
• Proficiency in SAS and/or R
• Strong analytical and technical writing skills