Ø More than three years of experience in programming, analyzing and reporting in clinical trial industry using SAS on Windows and UNIX environments.
Ø Knowledge of the drug development process with strong experience of analyzing and reporting in phase I to IV of clinical trial data in various therapeutic areas such as Oncology, Autoimmune diseases, Ophthalmology and Diabetes Mellitus.
Ø Extensive experience in BASE SAS, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ACCESS, SAS/ODS, SAS/CONNECT in windows and UNIX environments.
Ø Used various SAS report generating procedures such as Proc REPORT, Proc SQL, Proc FREQ, Proc MEANS, Proc TABULATE, Proc TRANSPOSE.
Ø Experience in merging SAS Data sets, Preparing Data, PROCs, Producing reports, SAS Formats, SAS Functions, SAS INFORMATs, storing and managing data in SAS Files.
Ø Good understanding of Clinical Trials (Phase I-IV), 21 CFR Part 11 and GMPs (Good Manufacturing Practices)
Ø Familiar with Clinical Terminology and Regulatory Guidelines.
Ø Good understanding of CDISC SDTM models and experience in converting legacy data to CDISC SDTM (Study Data Tabulation Model) Standards.
Ø Knowledge of Study Protocol, Design document, SAP (Statistical Analysis Plan) and CRF-Annotation (Case Report Form).
Ø Worked with Biostatisticians and clinical data managers to provide SAS Programming in analyzing the data, generating Reports, Tables, Listings and Graphs.
Ø Good working knowledge of Clinical Trials data like Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), Lab data, physical and vital signs and healthcare data.
Ø Working knowledge of PROC TTEST, PROC ANOVA, PROC GLM, and PROC SUMMARY, Chi-Square Test, Fisher's Exact Test, Mantel-Heanszel Chi-Square Test , Cochran-Mantel-Heanszel Chi-Square Test, Two Sample Ttest, PROC Npar1way, Wilcoxon Signed-rank Test, Wilcoxon Rank Sum Test, Kruskal-Wallis Test, Regression Analysis, Multiple Linear Regressions, LOGISTIC Regression, PROC UNIVARIATE in data cleaning
Ø Strong command over Structured Query Language (SQL). Knowledge of relational database management system.
Ø Experienced in producing RTF, HTML and PDF formatted files using SAS/ODS.
Ø Good communication, motivation, team building and leadership skills. Quick learner and ability to meet deadlines under pressure.
SAS Tools: SAS V8/V9 BASE SAS, SAS/GRAPH, SAS/MACROS, SAS ODS, SAS/REPORTS, SAS/ACCESS, SAS/STAT, SAS/CONNECT.
SAS Procs: Print, Means, Univariate, Correlation, Regression, SQL, Report, Freq, Sort, Summary, Format, Import, Export, Transpose, Compare, Gplot and Gchart, Append, ANOVA, Print.
Database: SQL and MS Acess.
Statistical Software: SAS
Operating Systems: Windows, UNIX
Preliminary eye examination
Electronic Medical Record documentation
Performed codlings such as ICD, CPT, HCPC, LOINC, SNOMED-CT, NDC etc.
Performing data analysis using SAS, SQL and Microsoft Excel
Worked on Phase II and Phase III clinical trials.
Produced derived data sets, listings, tables for data analysis.
Worked with Statisticians and data managers.
Used various BASE SAS procedures such as Proc Print, Proc Means, Proc Freq, and Proc Report.
Used SAS/ACCESS to import and export data to and from MS Access and Excel.
Responsible for choosing appropriate statistical techniques relevant for the analysis of data.
Used SAS/GRAPH to generate figures as per Statistical Analysis Plan.
Developed SAS Programs to
validate the data and used different validation techniques such as PROC UNIVARIATE, PROC MEAN and PROC FREQ.
· Export and import SAS data sets from and to Excel
Worked on the summary of clinical data like Demographics, Adverse Events (AE), Labs, Subject Matter Summary and ECG's.
Extensively involved in clinical data analysis and preparation of SAS Data sets, Listings and tables according to the Statistical Analysis Plan (SAP) and Clinical Protocols.
Developed SAS programs using SAS/BASE, SAS/SQL, and SAS/MACROS for statistical analysis and data displays.
Checked for data related errors and missing values.
Developed reports using Proc REPORT.
Used existing macros and developed SAS Programs for Data Cleaning, Validation, and Analysis and Report generation.
· Attended project meetings with Clinical Data Manager and Biostatisticians.
Companies Worked For:
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