Manisha Chaudhari
Statistical Programmer at Saama- Claim this Profile
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Bio
Experience
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Saama
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United States
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Software Development
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700 & Above Employee
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Statistical Programmer
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Aug 2022 - Present
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Cognizant
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United States
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IT Services and IT Consulting
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700 & Above Employee
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Analyst - Bio Statistical Programmer
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Jun 2020 - Aug 2022
• Understand the requirement of study documents, Protocol, SAP, CRF and derive the datasets. • Investigated missing data and data anomalies in SAS datasets and raw files. • Developed and validated SDTM Datasets. • Creation of mapping specification including Trail Design Domain (TDD)and annotated CRF. • Self-validation and peer review of mapping specifications, TDD and SDTM annotated CRF • Review and validation of SDTM / Define. Xml using Open CDISC validator. Communication of Open CDISC validator hits and discrepancies back to DM/Bio-stat departments. • Created Efficacy Patient Profiles and define.xml for regulatory submissions. • Trained team for migration activities. • Generate ADaM with accordance with Specification. • Coordination and interaction with client business team • Deliver and maintain quality & timeliness of assigned tasks. • Creation of Study Data Reviewer's Guide for SDTM • Trained in Biostatistics and Statistical Programming (BOOT) camp. • Generate Tables and Listings with reference to the Statistical Analysis Plan Show less
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Jr. Analyst - SAS Programmer
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Sep 2017 - May 2020
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Trainee SAS Programmer
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Sep 2016 - Aug 2017
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Education
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University of Pune
Master of Computer Applications (MCA), Computer Science -
Savitribai Phule Pune University
Bachelor of Computer Science, Computer Science