Lead Biostatistician

About the role

The Lead Biostatistician is responsible for providing statistical support for clinical study design, analysis, and reporting for registration/pre-market approval (CE-IVD and US-IVD) of qualitative and quantitative IVD molecular assays for blood biomarkers, hematology, infectious disease, and oncology applications across Danaher Diagnostics Op Cos.

What you'll do

• Help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies
• Provide end-to-end statistical analysis support for IVD product life cycle development through creation and verification of multiplex biomarker signatures in infectious…
• Provide statistical input in clinical study designs including sample size estimates using OC and power curves while ensuring the team understands statistical risks of…
• Review and update standard operating procedures for relevant functions, provide statistical training/education programs to junior statisticians as needed and support…
• Provide expert biostatistics input for analytical studies such as reproducibility and precision studies, interfering substances, limit of detection (LOD)

What you need

• 10–18 yrs of experience
• Regulatory affairs
• Python
• Statistics
• SAS
• R
• SOP writing
• M.Sc or PhD