Navin M Email & Phone Number

Multiple years of experience as a SAS Programmer/Analyst in different Clinical Research Organizations (CRO) and bio-pharmaceutical industry.Experience in drug safety as ICSR processin on safety data bases like, Argus, Arisg, Scepter etc.Hands-on in data analysis and statistical programming in Phase I, Phase II & Phase III clinical trials.Well understanding of clinical trial process, Study Designs & Protocols, Statistical Analysis Plans (SAP) and Case Report Form (CRF/eCRF).Produce SDTM domain models from raw data.Produce Analysis/derived datasets using ADaM standards.Generate Tables, Listings and Graphs (TLG's) using Base SAS, Macros, SAS/Graph and SAS/ODS according to Statistical Analysis Plan (SAP).Experience working in different therapeutic areas such as oncology, neurology, cardiovascular etc.Experience in annotating CRF and table shells as per Clinical Data Interchange Standards Consortium (CDISC) standards.Anaysis metadata Specifications and create SDTM mapping Specifications. Create ADHOC Reports and Graphs. Creation of Macros for standardizing processes. SDLC (System/Software Deveopment Life Cycle). Worked with EDC (Electronic datacapture) systems, like ORACLE Inform.Proficient in writing SAS data step programs and macros for SDTM and ADaM datasets. Experience in performing edit checks for data cleaning as per data management plan.SAS MACROS programming. Implementing data manipulation techniques, and statistical procedures (e.g., PROC UNIVARIATE, PROC REPORT, PROC FREQ, PROC SUMMARY, PROC MEANS, PROC ANOVA, PROC LIFETEST etc).

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  Drug Safety Associate

  Synowledge Llc

  United States