HARINI MUPPIDI

• Extensive knowledge in all phases (I-IV) of clinical trials, pre-clinical studies.
• Solid knowledge of clinical procedure, clinical diagnostic method, medical and drug terminology, laboratory techniques, clinical lab results.
• Experience in using various SAS modules like BASE SAS, SAS/EG, SAS/Studio.
• Facilitate the modification and development of existing SAS programs as well as accountable for the creation of new programs using SAS Macros.
• Excellent knowledge of statistical procedures: SUMMARY, ANOVA, GLM, MEANS, and UNIVARIATE.

• Hands on experience using SAS procedures like SAS/STAT (FRQ, ANOVA, GLM, GLMMOD, LIFETEST etc.,), SAS/GRAPH (SGPLOT, SGPANEL, SGSCATTER).
• Developed SAS programs for listing of tables for data review and presentation including Adhoc reports, CRTs as per CDISC.
• Commendable knowledge of CDISC standards like Study Data Tabulation Model (SDTM), Analysis Dataset Model (ADaM).
• Perform extensive QC (Quality Check) and analysis in reviewing data and render primary support and assistance in data validation and data cleaning in all phases of Clinical studies.

• Served as lead validator for validating vendor data to check the client compliance and data standards.
• Perform P21 checks on datasets in accordance with the standards for data compliance.
• Generated reports, tables, listings, and graphs according to Statistical Analysis Plan, Standard Operating Procedures, and departmental guidelines.
• Experience in implementing SAS procedures, Macros and applications for data cleaning, reporting, and documentation.
• Familiar with FDA Electronic submission standards and CDISC standards.
• Analyzed datasets to verify compliance with CDISC standards and electronic submissions.
• Good experience in storing and managing data in SAS files, merging SAS data sets, using ARRAYS and MACROS, SAS Procedures, SAS Formats, and SAS Informats.
• Hands on with analyzing Case Report Forms (CRF) data, Clinical Trials, Clinical Data Analysis, Clinical Data migration, Validations and Documentation.
• Experienced in creating patient profiles and patient narratives.
• Capable of problem solving and delivering realistic and practical solutions.
• Strong communication, interpersonal and organizational skills.