PROFESSIONAL SUMMARY:

• 6 years of clinical data analyses using SAS in Clinical Research Organization CRO and pharmaceutical companies.
• Full experience in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/INSIGHT, SAS/ACCESS, SAS/CONNECT, and SAS/ODS
• Generate and validate datasets and tables such as Demographics DM , Vital Signs VS , Adverse Events AE , and Laboratory Test Result LB
• Proficient with TLF generation and validation following with the standard of CDISC, includes SDTM, ADaM datasets and DEFINE document
• Extensive experience in various SAS report generating procedures like DATA NULL , PROC REPORT, PROC FORMAT, PROC FREQ, PROC UNIVARIATE, PROC MEANS, PROC TRANSPOSE and PROC SQL
• Excellent experience in exporting SAS results to different formats, such as RTF, PDF, Excel and XML files by using SAS/EXPORT, SAS/ODS
• Trained in Good Clinical Practice GCP , Regulatory Compliance and FDA Guidelines
• Rich Experience of clinical trials of Phase I through IV, ICH Guidelines, NDA, IND and FDA procedures of FDA 21 CFR Part 11
• Comprehensive knowledge of advanced Statistic Analysis Method including regression analysis PROC REG , Analysis of variance PROC ANOVA , Analysis of categorical data PROC LOGISTIC , Time Series Analysis, Multivariate Analysis PROC GLM, PROC MIXED , Nonparametric Analysis PROC NPAR1WAY , and in-house procedures
• Strong skills in connecting SAS System with database systems, such as Microsoft SQL and Oracle, to retrieve data and create SAS datasets
• Solid background and formal education in statistics modeling, experimental design, and other statistics concepts
• Expertise in Data archival and Data migration, ad-hoc reporting and code utilizing SAS on UNIX and Windows Environments
• Technical Skills
• Operating Systems : Windows, DOS, UNIX, LINUX
• Programming Languages : SAS, SQL, C, C , VB, HTML, MATLAB, Latex
• Database : Oracle, DB2, MS SQL Sever
• Software : MS Word, MS Excel, MS PowerPoint, MS Access,
• Acrobat Professional

Work Experience:

Confidential

Senior SAS Programmer

Responsibilities:

• Optimize performance using Data Validation and Data cleansing on Clinical Trial data using Statistical procedures like PROC FREQ, PROC MEANS, and PROC UNIVARIATE
• Create SAS datasets by extracting data from Oracle clinical database using SAS/SQL and SAS/ACCESS and prepare them for statistical analysis
• Customize SAS outputs such as RTF, HTML, PDF and XML files with PROC TEMPLATE
• Document and maintain SAS programs/Macros, including independent development of Macros and utilizing existing Macros
• Provide support with tables, patient data listing, graphs/box plot and report for ISS, ISE
• Prepare Define document for NDA submission to regulatory authority
• Standardize datasets with CDISC standards, such as SDTM, ADaM
• Work with Clinical Data Management team for creating annotated CRF
• Conduct and generate the Regression, Correlation studies and Analysis of Variance using PROC REG, PROC CORR, PROC GLM, PROC ANOVA
• Develop and execute application programs using SAS to generate tables, figures and data listings for statistical analysis with various procedures like PROC FREQ, PROC MEANS, PROC SUMMARY and PROC DATASETS to develop customized reports
• Develop and maintain general-purpose SAS Programs/Macros for the validation, extraction, presentation, manipulation, analysis, and reporting
• Generate clinical trial graphs by procedures from SAS/GRAPH, like PROC GPLOT, PROC REG, PROC GCHART, and PROC BOX PLOT
• Prepare SAS XPORT transport file by using the DATA step, PROC COPY and SAS/MACRO for submission

Confidential

Role: SAS Programmer

Responsibilities:

• Generated analysis datasets needed for statistical analysis and TLF based on study requirements.
• Provided SAS programming to support clinical trials studies.
• Built Macros to produce customized tables PROC REPORT, PROC MEANS, PROC SUMMARY, PROC MIXED, and PROC FORMAT were applied to generate various data tables, patient data listings and reports according Statistical Analysis Plan.
• PROC GPLOT, and PROC GREPLAY were used to build graphs with Marcos .
• Developed reports using procedures such as REPORT, TABULATE and DATA NULL
• Applied exiting Macros to produce customized graphs.
• Cross-validated SAS programs authored by other SAS programmers as a part of QC Quality Control Validated the programs and reviewed outputs including datasets, tables and graphs in reports.
• Performed data integrity checks and data cleaning using SAS Macros and data step.
• Assured the quality of databases by doing derived variable validation and missing value imputation.
• Prepared documents upon study completion, as well as various reports related to clinical research.

Confidential

Role: SAS Programmer

Responsibilities:

• Imported the data from Relational Databases via SAS/CONNECT, SAS/ACCESS, PROC SQL Pass-Through Facility and the SAS/ ACCESS LIBNAME engine
• Worked closely with data management department to clean the data through the data query process
• Used various procedures like PROC FREQ, PROC MEANS, PROC SUMMARY and PROC DATASETS to develop customized reports
• Modified, validated and implemented SAS programming work according to Statistical Analysis Plan
• Validated SAS programming and results using PROC COMPARE and prepared QC documentation
• Outputted data tables, patient data listings, graphs and reports using SAS procedures such as PROC REPORT, PROC PRINT, PROC GPLOT, and PROC TABULATE
• Wrote Edit check programs and generated the listings of clinical trial data
• Developed SAS programs and Macros to produce clinical reports including customized tables, listings and graphs summarizing descriptive and inferential statistical analyses

Confidential

Role: SAS Programmer

Responsibilities:

• Loaded data into SAS and organized data into the formats for the further analysis
• Generated data tables, patient data listings and datasets using SAS procedures such as PROC FREQ, PROC MEANS, PROC SORT, PROC TRANSPOSE, and PROC DATASETS
• Used various procedures like ODS, Data Null , PROC REPORT, PROC PRINT, PROC GPLOT to develop customized reports
• Performed statistical analyses with procedures such as PROC UNIVARIATE, PROC LOGISTIC and PROC ANOVA according to Statistical Analysis Plan
• Created SAS Datasets from MS SQL Server database
• Organized datasets into forms for statistical analyses by merging, combining, splitting, and coding, and performed edit-check for datasets to assure the quality of the datasets
• Validated outputs with PROC CONTENTS and PROC COMPARE Developed case report forms, data validations, and data quality plans
• Implemented study specific procedures compliant with regulatory and internal procedures and requirements
• Designed, documented, tested, implemented and managed clinical data Reviewed reporting systems for clinical studies and assured clarification Managed assigned project timelines and prioritization of tasks