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Lead Biostatistician

Beckman Coulter·Bengaluru

Pay not stated10–18 yrsFull-time

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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
  • Responsible for providing statistical support for clinical study design, analysis
  • 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…

What you need

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

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