Ansuya Gupta
Senior Biostatistician at Covance
- Role
- Senior Biostatistician at Covance
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Ansuya Gupta
Extensive experience of 12 years in industry as a biostatistician for Clinical trials ranging from Phase I to IV for different therapeutic areas like Oncology, Diabetes, Vaccine, Gynecology, Chronic Obstructive Pulmonary Disease (COPD) etc. and bioequivalence studies. Strong leadership in statistical methodologies and extensive hands on experience in designing studies, inputs in protocol, sample size calculations, reviewing Annotated CRF’s and data specification, preparing and reviewing SAP, Statistical analysis report (SAR), creating and validating TLF’s for efficacy analysis, inputs in CSR. Worked on FDA-EMEA-ANIVSA-MCC-DCGI queries and CDISC standards-SDTM and ADaM. Worked with SAS, Phoenix/WinNonLin and MS Office. Worked on both Early and late phase studies.
Experience
Senior Biostatistician
Dec 2020 — Present · New York, NY, US
Education
Gujarat University
M.Phil, Statistics
2000 — 2004
Gujarat University
Master's degree, Statistics
Skills
- Pharmacovigilance
- Ich-Gcp
- Sas Programming
- Clinical Development
- Clinical Data Management
- Statistical Modeling
- Regulatory Affairs
- Winnonlin
- CRO
- Logistic Regression
- Decision Trees
- Pharmaceutical Industry
- Biostatistics
- Regulatory Requirements
- Regression Analysis
- Statistics
- Gcp
- Pharmacoepidemiology
- Clinical Study Design
- Protocol Design
- Clinical Trials
- Clinical Research
- Sas
- Pharmacokinetics
- Sas Base
- Cdisc
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