SUMMARY

• SAS Certified Clinical Trials programmer using SAS 9 and Base programmer for SAS 9with around 5 years of experience working with SAS and SAS tools emphasizing on analysis, design, developing, testing and implementation of various projects for Pharmaceutical and health care industries on windows environment.
• Extensive experience in BASE SAS, SAS/STAT, SAS/GRAPH, SAS MACROS, SAS/ACCESS, SAS/SQL, SAS ODS.
• Experienced in Base SAS procedures such as PROCFREQ, MEANS, SUMMARY, UNIVARIATE, FORMAT, IMPORT, EXPORT, REPORT, TABULATE, TRANSPOSE, DATASETS, COPY and PRINT.
• Experience in SAS programming for extracting data from Flat files, Excel spreadsheets and external RDBMS (ORACLE) tables using LIBNAME and SQL PASSTHRU facility.
• Experience in using SAS to read, write, IMPORT and EXPORT to another data file formats, including delimited files, Spreadsheet, Microsoft Excel and access tables
• Skilled in SAS programming, merging SAS datasets, SAS formats and managing data.
• Experience in using SAS/STAT procedures like PROC ANOVA, PROCREG, and PROC CORR.
• Experience in dynamic programming and list processing using SAS/MACRO.
• Programming skills in joining, merging, and extracting data from various databases using PROC SQL.
• Experience in using SAS/GRAPH procedures like PROCGPLOT, PROCGCHART and PROCBOXPLOT.
• Experience in using the ODS facility to create HTML, RTF, XML and PDF files.
• Successfully increased portability of existing SAS programs and created new programs using SAS macro variables to improve efficiency and consistency of the reports with MACROS.
• Knowledge of the drug development process with strong experience of analyzing and reporting in phase I, II, III and IV of clinical trial data.
• Knowledge of FDA regulations, ICH Guidelines and GCP requirements and clinical terminology.
• Good knowledge of CDISC standards like SDTM domains and AdaM.
• Expertise in analyzing and coordinating clinical trial data, generating reports, tables, listings and graphs.
• Extensively used and created macros for statistical and reporting purposes.
• Documented SOP, work instruction, processes and standards as per FDA regulations.
• Highly self - motivated and goal-oriented professional with rational problem solving and sound decision making capabilities.

TECHNICAL SKILLS

SAS Tools: SAS 9.1/9.2, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/GRAPH, SAS/STAT, SAS/SQL, SAS/ODS.

SAS Procedures: Proc print, Means, Univariate, Report, SQL, Tabulate, Freq, Sort, Format, Copy, Compare, Gplot, Transpose.

Languages: SAS, SQL, PL/SQL, HTML

RDBMS: Oracle, MS Access, DB2, and SQL Server.

Office tools: MS office 2003/2007/2010, Word, Excel and PowerPoint.

Operating Systems: Windows XP/2000/NT/98

PROFESSIONAL EXPERIENCE

Confidential, Atlanta, GA

SAS Clinical programmer

Responsibilities:

• Successfully implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed Phase I to Phase IVClinical Trials data.
• Proficient in drawing flowcharts indicating the input data sets, sortingand merging techniques to get the required report.
• Developed and maintained programs in SAS using SAS tools for Windows in a user support environment.
• Extensive experience with the SAS programming and in data step and with various SAS Procedures in Base SAS and SAS/Stat, including thorough knowledge of SAS Macro Language.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools such as SAS/Base, SAS/Macros and SAS/Graph, SAS/SQL.
• Program documentation on all programs, files and variables for accurate historical record and for future reference.
• Convert MS-Word documents, MS-Excel, SQL tables into data sets.
• Extensively used SAS/ Macro facility to provide reusable programs that can be conveniently used time totime.
• REPORT, SUMMARY and also provided descriptive statistics using PROC-Means, Frequency, Univariate.
• Formatted HTML and RTF reports, using SAS - output delivery system ODS.

Environment: SAS/Base 9.0, SAS/Macros, SAS/Stat, SAS/Graph, SAS/ODS, SAS/SQL, SAS/Connect, SAS/Access, MS-Excel, MS-PowerPoint.

Confidential, Montvale, NJ

SAS Programmer - Clinical

Responsibilities:

• Involved in managing randomized phase II and IIIclinicaltrials data.
• Extracted data from Oracle using SQL Pass through facility and generated ad-hoc reports.
• Maintenance of large data sets, combining data from various sources in varying formats to createSASdata sets and/or ASCII files by using Set and Merge.
• Developed new or modifiedSASprograms to load data from the source and create study specific datasets, which are used as source datasets for report generating programs.
• Prepared new Datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, and Update, Formats, Functions and conditional statements.
• Created complex and reusable Macros and extensively used existing macros and developedSASPrograms for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.
• Generated Tables, Graphs and Listings for inclusion inClinicalstudy reports and regulatory submission; Participated in preparing study results as well as ISS and ISE for FDA submissions usingSAS.
• Modified macros for report generation as per the statistician’s requirements.
• Developed efficacy and safety tables including Adverse Events table, Laboratory Shift table and Concomitant Medication tables.
• Generated summary reports, listing and graphs using procedures like PRINT, REPORT, MEANS, FREQ, TABULATE, UNIVARIATE, GPLOT and GHART.
• Attended project team meetings, worked with Bio-Statisticians, Data Managers, andClinicalResearch Managers as appropriate. Reviewed and provided feedback for Data Integrity Plans.

Environment: SAS/BASE, SAS/STAT, PL/SQL, SAS/GRAPH, SAS/SQL, SAS/MACROS, SAS/ODS, SAS/ACCESS, SAS/CONNECT, SQL Server, WINDOWS and MS Office.

Confidential

SAS Clinical Programmer

Responsibilities:

• Involved in screening, cleaning & integration of data.
• Worked with Statisticians in analyzing the Clinical Trial Data, generated reports, tables, listings and graphs using SAS in accordance with the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs) and departmental guidelines.
• Provided analytic support to statisticians in the production of Clinical Study Reports.
• Produced accurate, precise tables and graphs for Clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with 21CFR Part 11.
• Developed SAS programming for extracting data from flat files, Excel spreadsheets and external RDBMS (ORACLE) tables using LIBNAME and SQL PASSTHRU facility.
• Database Creation and Table Programming for ISS and ISE.
• Done data analysis using SAS/Stat procedures such as Procfreq, univariate, test, etc.
• Managed missing data and used sort and merge techniques to get the required output.
• Created SAS Customized Reports using the Data Null technique for FDA evaluations.
• Produced efficacy and safety summary results with tables, listings, and graphs for company’s clinical trials, performing quality control of other programmers work and debug complex programming code.

Environment: SAS 8, SAS/BASE, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/Access, EXCEL, Win NT.

Confidential

SAS Clinical Analyst

Responsibilities:

• Reviewed and evaluated clinical research related programs,
• Programming of data listings using SAS.
• Programming of data validation tools using SAS.
• Involved in Phase II and phase III clinical trial data analyses.
• Verified the accuracy and integrity of clinical data by performing validation checks and investigate data related errors, outliers, and missing values. Developed SAS macros for data cleaning and reporting.
• Involved in preparation, developing data, analyzing, coding, report generation and testing programs according to client’s requirements.
• Extracted raw data from the warehouse and created SAS data sets that are required for the project analysis using SAS/ACCESS and SAS/CONNECT.
• Testing and debugging macros.
• Used frequently PROC TABULATE, PROC REPORT, PROC SUMMARY, PROCUNIVARIATE, PROCFREQ, PROC ANOVA and PROC REG. Strong knowledge in t-test, F-test and Chi-square (c2) test.
• Used PROC PRINT and ODS objects to get customized reports.
• Used PROC ANOVA, PROC MEANS and other analysis procedures in generating real time reports.

Environment: SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT, SAS/ODS, SAS/Access.