Staff Biostatistician (Clinical Validation)

What you’d do

Lead the design, analysis, and interpretation of clinical validation studies for in vitro diagnostics, including CDx, 510(k), and PMA submissions. Serve as statistical lead on high-priority project teams and drive statistical interactions with regulators such as the FDA. Found on the employer's careers page on Oct 17, 2026. Apply through the link.

You’ll need

• PhD or Master's in biostatistics, statistics, or related field
• 8+ years relevant industry experience
• CDx or IVD submission experience
• Experience in regulated environments
• FDA statistical interaction experience