SUMMARY

• Extensive experience in SAS programming in the areas of Pharmaceuticals, Banking and Healthcare.
• Extensively used SAS for data analysis, generating reports, tables, listings, and graphs in clinical trials and worked closely with clinical data managers on clinical operations.
• Experience in SAS/BASE, SAS/ACCESS, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/SQL in Windows environment.
• Generating SDTM and ADaM datasets using SAS as per sponsor specifications.
• Good understanding ofClinicalTerminology, FDA regulations, ICH Guidelines and GCP requirements.
• Expert in using PROC SQL, PROC REPORT, PROC IMPORT/EXPORT, PROC FORMAT, PROC TABULATE, PROC PRINT, PROC SORT, DATA MERGE, DATA NULL, to generate customized reports.
• Mapping of data according to CDISC standards. Prepared SDTM and ADaM data sets as per CDISC standards.
• Experience in QC SAS programs for Dataset, tables, listings, and figures following the departmental QC procedures.
• Extensive experience in SAS/STAT procedures such as PROC FREQ, PROC MEANS, and PROC UNIVARIATE.
• Developed SAS programs for various analyses in Phases I, II and III of Clinical Trials.
• Good noledge of Life Sciences with extensive experience in the clinical trial processes and their designs.
• Generating tables and listings of adverse event (AE), demography (DM), vital sign (VS), safety dataset, efficacy dataset, and concomitant medication (CM) datasets.
• Proficient in importing or extracting data by connecting SAS System to database systems such as Microsoft SQL, Excel, Access, flat files and exporting data to generate dynamic reports in delivering to the third parties by using SAS/ODS.
• Successfully handled responsibilities for extracting internal/external data, data cleaning, and validation, developing statistical models, analysis, and report generation.
• Strong ability to understand job requirements, new methods, ideas, concepts, and technologies.
• Exceptional problem - solving skills with excellent communication skills, detail oriented, enthusiastic to work in a fast-paced environment.

PROFESSIONAL EXPERIENCE

Confidential, NC

SAS Programmer

Responsibilities:

• Produced analysis datasets for generating reports.
• Prepared new datasets from raw sets files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, Formats, and Functions.
• Produced quality customized reports by using PROC TABULATE, REPORT and SUMMARY and also provided descriptive statistics using PROC MEANS, FREQ and UNIVARIATE.
• Used ODS statements to generate different output formats like HTML, PDF and excel to view them in the web browser.
• Cleaning existing data and converted them into useful SAS Datasets, merged datasets and created reports based on Ad-hoc requirements.
• Imported raw data files in excel format in SAS and subsequently created SAS Datasets and performed data manipulations on the datasets.
• Performed Data Validation and Data Cleaning on Clinical Trial data. Finally converted them into Transport files.
• Performed quality control (QC) methods and processed for programming deliverables in both study and submission level activities.
• Used various Statistical Procedures like PROC FREQ, PROC REG, and PROC ANOVA to analyze data and generate reports.
• Extracting the data from various internal and external database (Oracle, DB2, Excel spreadsheets) using SAS/ACCESS, SAS/INPUT.
• Involved in preparing clinical trials data for FDA submissions according to 21 CFR Part 11 and involved in listing, summary tables for NDA submission.
• Participated in clinical project meetings and provided input, whenever relevant.

Environment: SAS 9.2, Windows XP/Vista, SAS/BASE, SAS/MACROS, TABULATE, FREQ, SORT, SUMMARY, IMPORT, EXPORT, REPORT, Microsoft Office.

Confidential, Greensboro, NC

Clinical SAS Programmer

Responsibilities:

• Reading and understanding the study annotated Case Report Forms, Study Definition documents, software tools and working with SAS.
• Importing and exporting raw data files, manipulate and transform data, combine SAS data sets, create basic detail and summary reports using SAS procedures.
• Worked on Data Management SAS DATA step processing, PROC SQL for data extraction, write datasets, Report and use of PROC REPORT, DATA NULL, SAS Macro processing.
• Generated analysis data sets for both safety and efficacy parameters based on the guidelines provided in the SAP (Statistical Analysis Plan).
• Modified data sets using set, merge, sort, update, formats, and functions.
• Developed routine, user friendly SAS macros to create tables, and listings for inclusion in Clinical study reports and regulatory submissions.
• Produced summaries and statistics using PROC MEANS, PROC SUMMARY, PROC FREQ, and PROC ANNOVA.
• Used SAS ODS to create RTF, HTML, and PDF outputs files in the process of producing reports.
• Developed and validated SAS programs for SDTM and ADAM datasets.
• Successfully validated study TLG's through independent validation using PROC COMPARE.
• Performed data analysis, statistical analysis, generated reports, listings and graphs using SAS TOOLS - SAS/BASE, SAS/SQL, SAS/CONNECT AND SAS/ACCESS.
• Generated graphs using SAS/GRAPH and the SAS Graphics Editor.
• Efficiently generated SQL queries for data manipulation, analysis and report generation.

Environment: SAS 9.2, SAS/SQL, SAS/BASE, SAS/MACROS, SAS/GRAPH, SAS/ODS, SAS/ACCESS, MS Excel, Windows XP.

Confidential, Raleigh, NC

SAS Programmer

Responsibilities:

• Worked with various SAS products SAS/BASE, SAS/STAT, SAS/GRAPH, and SAS/MACROS to develop required solutions.
• Created new analysis datasets from raw datasets for clinical trials.
• Handled clinical trials data of domains such as Adverse Events (AE), Concomitant medications (CM), and Vital signs (VS).
• Generated Tables, Listings, and graphs using procedures like PROC FREQ, PROC REPORT, PROC TABULATE, DATA NULL, and PROC GPLOT.
• Optimized data format for further analysis in terms of cleaning, validation, formatting and Labeling using PUT/ INPUT Functions, LABEL statement, and PROC FORMAT.
• Generated reports using PROC REPORT as per the Statistical Analysis Plan coordinating with senior statistician.
• Performed Data Validation and Data cleaning.
• Extracted datasets from database using SAS/ACCESS, LIBNAME Statement and other import methods.
• Developed and maintained programs in SAS using SAS tools for Windows in a user support environment.
• Used PROC SORT, SET, UPDATE and MERGE statements for creating, updating and merging various SAS datasets.

Environment: SAS 9.1, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, SAS/ODS, Windows, MS Excel.

Confidential, Frederick, MD

SAS Programmer

Responsibilities:

• Extensively involved in creation of reports and data analysis by the use of BASE SAS, SAS/MACROS and SAS/REPORTS.
• Created SAS datasets from different external files such as MS Excel, MS Access, CSV, tab delimited, Notepad, etc., using Import techniques.
• Manipulated SAS datasets using SET, MERGE and Conditional statements.
• Created and validated SAS programs for tables, listings, and graphs (TLG’s) according to specifications.
• Generated various clinical reports, and tables for Phase I and II clinical trial studies.
• Created output files in a variety of formats including EXCEL, RTF and PDF etc. using SAS/ODS and SAS/EXPORT for reporting and presentation.
• Developed SAS MARCOS for data cleaning and reporting.
• Documented all project data flows and programs and wrote edit check programs and listings of data.
• Ensured adherence to programming guidelines and properly coordinated the testing and documentation of the statistical programs.
• Completed the project with best quality control and within the given specified time.
• Performed validation and quality control of the output and involved in the generation of various e-submissions to the FDA.

Environment: SAS/BASE, SAS/ACCESS, SAS/MARCOS, SAS/ODS, MS Excel, MS Access, Windows.