Remote Biostatistician

Job Summary

To support innovative diagnostic development, the remote contract Statistician/Biostatistician will design, analyze, and validate clinical studies while collaborating with cross-functional teams.

Key responsibilities

• Write and review statistical analysis plans (SAPs) for analytical and clinical validation studies
• Calculate clinical accuracy metrics and deliver analyses to support regulatory filings
• Generate and QC protocol-aligned tables, listings, figures, and validated SAS macros

Required qualifications

• BS in Statistics/Biostatistics with 5+ years of experience, MS with 1+ years, or PhD
• Proven statistical experience within IVD, medical devices, pharma, or life sciences
• Advanced SAS programming skills (BASE, STAT, MACRO, GRAPH) and familiarity with CLSI standards
• Solid background in linear/non-linear modeling, mixed models, and sample size calculations