Durai Guna
Principal Biostatistician @Novartis Oncology
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WORK HISTORY
Principal Biostatistician @Novartis Oncology
Hyderabad, IN
Key Deliverables & Areas of Focus:• Trial Activities: Statistical Analysis Plan (SAP) development, TFL preparation, Clinical Study Report (CSR) production, and Manuscript drafting.• Regulatory Submissions: Strategic preparation of responses for Health Authority (HA) questions.• Safety Statistics: Primary statistical support for pharmacovigilance documents, including Periodic Safety Update Reports (PSUR), Development Safety Update Reports (DSUR), and Investigator\'s Brochures (IB).
EDUCATION
National Institute of Mental Health and Neuro Sciences (NIMHANS), India
Master's degree, Biostatistics
National Institute of Mental Health and Neuro Sciences (NIMHANS), India
Doctor of Philosophy - PhD, Biostatistics
Government Arts College, Coimbatore
Bachelor of Science, Statistics
ABOUT DURAI GUNA
Highly accomplished Principal Biostatistician with a dual focus on Clinical Trial and Safety Statistics. Expertise in regulatory submissions and comprehensive trial documentation.
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