Lead Biostatistician
BengaluruFull-time10–18 yrsPosted over a month ago
Leadership data science role at Danaher in Bengaluru. Needs 10+ years and an M.Sc or PhD.
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
- Regulatory affairs
- Python
- Statistics
- SAS
- R
- SOP writing