Bipasa Biswas
Assistant Director at FDA
- Role
- Assistant Director, Division of Biostatistics, Office of Clinical Evidence and Analysis at FDA
- Location
- Germantown, MD, US
- LinkedIn followers
- 500 followers
About Bipasa Biswas
I work as a mathematical statistician at the Center for Devices and Radiological Health (CDRH), reviewing pre-market submissions for diagnostic devices. I review protocols for pre-submissions, IDE, 510(k) and PMA mainly for diagnostic devices. I review study design, statistical analysis plan and clinical study protocols for various diagnostic devices.
Experience
Assistant Director, Division of Biostatistics, Office of Clinical Evidence and Analysis
Feb 2020 — Present
Education
University of Maryland
MA, Mathematics
1991 — 1996
Lady Irwin Senior Secondary School
High School
1975 — 1985
Delhi University
BSc, Mathematics
1985 — 1988
The George Washington University Columbian College of Arts & Sciences
Doctor of Philosophy (Ph.D.), Biostatistics
2006 — 2014
University of Maryland
Master's degree, Mathematical Statistics and Probability
1996 — 2002
Indian Institute of Technology, Delhi
MSc, Mathematics
1988 — 1990
Skills
- Analytics
- Business Analysis
- Predictive Modeling
- Analysis
- Biostatistics
- Linear Regression
- Sas
- R
- Clinical Trials
- Statistics
- Spss
- Data Analysis
- Sas Programming
- Proposal Writing
- Statistical Modeling
- Program Management
- Business Intelligence
- Data Mining
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