Clinical Biostatistician Consultant

Job Summary

Detail-oriented and analytical, the part-time Clinical Biostatistician Consultant will provide statistical support for clinical studies involving medical devices, collaborating with cross-functional teams to design methodologies, analyze data, and contribute to regulatory submissions while ensuring compliance with FDA regulations.

Key responsibilities

• Develop Statistical Analysis Plans (SAPs)
• Perform statistical analyses using SAS and/or R
• 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