SUMMARY

• SAS Programmer with 7+ years of experience in Pharmaceutical and Healthcare industry involving data management and statistical analysis for clinical trials.
• Knowledge of the drug development process with strong experience of analyzing and reporting in phase i, ii, iii and iv of clinical trial data
• Extensive experience in BASE SAS, SAS MACROS, SAS/STAT, SAS/ACCESS, SAS PC (V9.0), SAS/GRAPH.
• 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.
• Excellent command in producing reports employing various procedures like PROC SQL, PROC REPORT, PROC TABULATE, PROC SORT, PROC TRANSPOSE, PROC UNIVARIATE, PROC ANOVA, PROC SUMMARY etc.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines and hands on experience in implementing CDISC/SDTM standards.
• Extensively used PROC REPORT with ODS feature to develop various HTML, RTF and PDF reports.
• Experience in extracting data and creating SAS datasets from various sources like Oracle database, Access database, Excel and flat files using Import techniques.
• Experience in developing Macros using SAS procedures
• Experience in developing, validating and implementing SAS programs and produce derived datasets for analysis and generating & documenting tables, listings and graphs for clinical study reports.
• Excellent knowledge of SAS Procedures: PROC FREQ, PROC UNIVARIATE, PROC REG, PROCTTEST, PROC ANOVA.
• Generated reports using PROC REPORT, DATA NULL and PROC TABULATE for customized report writing.
• Experience in producing RTF, PDF, and HTML files using SAS ODS.
• Experience in interacting with CRO and ensuring proper and timely delivery of TLFs and analysis datasets and also performing proper review and validation.
• Good understanding of Clinical Trial Phases, clinical protocols/ CRF’s/Annotated CRF’s, ICH and GCP guidelines, NDA, IND, CDISC, MedDRA, 21 CFR PART 11.
• Familiar with Electronic submission guidelines to FDA.
• Strong communication skills and can work well in a team.

TECHNICAL SKILLS

Statistical Packages: SAS

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

Clinical App: Oracle Clinical 4.i/4.1/4.0,Oracle Forms 4.5

Operating Systems: Windows 98/2000, Windows XP, UNIX

Databases: Oracle 8.x/7.x, SQL Server 2000, MS Access

SAS Procs: Print, Means, Univariate, Correlation, Regression, SQL, Report, Freq, Sort, Summary, Format, Import, Export, Transpose, Compare, Gplot and Gchart.

Office Tools: MS Word, Excel, Access, PowerPoint.

PROFESSIONAL EXPERIENCE

Confidential, Philadelphia, PA

Sr.SAS Programmer

Responsibilities:

• Developed SAS programs to generate baseline, follow - up, drug safety reports from Oracle data base
• Develop SAS programs to generate data summaries, data listings and safety analysis.
• Statistical procedures were applied as per the protocols provided by bio statistician using SAS application.
• Graphical and html reports were generated on demographics, safety and baseline characteristics.
• Worked on data analysis, statistical analysis and generated Reports, Listings and Graphs using BASE SAS and SAS procedures such as PROC SUMMARY, PROC TABULATE, PROC FREQ, PROC SG -PLOT, PROC GPLOT and ODS procedure.
• Processed Quality control by creating SAS codes using various statistical procedures such as Proc Freq, Proc Means, Proc Univariate, Proc Summary, Proc Transpose, Proc SQL and Proc Print.
• Worked with different CDISC data models such as SDTM, ADaM and Define. xml
• Transformed raw data into standardized CDISC SDTM/ADaM domain datasets using various SAS procedures.
• Extensively used SAS/MACRO facility to provide reusable programs that can be conveniently used time to time and created tables, graphs and listing reports.
• Performed Edit check programming to identify potential data issues and conducted data validations for Integrated summaries of Safety and Efficacy (ISS/ISE).
• Reviewed protocol documents, case report forms, annotated CRF, and statistical analysis plans for clinical trials.
• Generated Ad hoc statistical analysis Reports/Listings as per FDA requirements.
• Created CRT (Case Report Tabulations) datasets using ODM model of CDISC standards for FDA Submission.
• Successfully validated TLG’s and CRT’s through independent validation using Proc Compare and standard Macros.
• Responsible for writing and debugging statistical programming and documented programming procedures.
• Provided SAS programming support to Statisticians, Data Managers, and the Medical Writers to develop reports.
• Existing datasets relating to multiple studies was modified using SAS Macros.
• Developed Tables, Listings and Graphs from Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Maintained appropriate study application documentation.
• Program documentation on all programs, files and variables was performed for accurate historical record and also for future reference.
• Optimized performance of Clinical trial data using data cleaning and data validation.
• Established and maintained sound working relationship and effective communication

Environment: BASE SAS v9.1.3, v9.2, SAS/MACROS, SAS/GRAPHS, SAS/ODS, SAS/STAT, Oracle Clinical, WINDOWS XP.

Confidential, MA

SAS Programmer

Responsibilities:

• Analyzed Phase I- III in clinical trials through SAS programming.
• Performed data analysis, statistical analysis, generated reports, listings and graphs using SAS tools- SAS/Base, SAS/Macros, SAS/Graph, SAS/SQL, SAS/Connect and SAS/Access.
• Generated graphs - Line chart, Pie chart, Bar charts, component bar charts using Proc GPlot and Proc GChart.
• Generated Listings, Summaries, Reports, Graphs i.e. TLGs as per SAP.
• Responsible for locating appropriate databases for projects and performing relevant analysis.
• Processed data collection to ensure proper quality of data.
• Maintained the daily error log for cleaning the data.
• Developed SAS macros for data cleaning, reporting and to support routing processing.
• Analyzed and interpreted numerical data from various sources organized and summarized data for analysis.
• Presented numerical information in various formats.
• Created SAS Customized reports using the Data null technique.
• Generated graphs using SAS/GRAPH and the SAS Graphics Editor.
• Used Proc Report to generate reports.
• Prolifically generated SQL queries for the reports.
• Organize datasets using Merge, Sort and functions etc.
• Good knowledge on ICH, GCPs and FDA regulations like 21 CFR part 11.
• Performed statistical procedures Proc Freq, T-Test, Anova, and Life test etc.
• Developed Macros to make SAS programming tasks easier and efficient.
• Modified Macros to generate report using SAS Macros based on Statistician’s requirements.
• Delivered outputs using ODS (HTML, PDF and RTF) formats.
• Worked in close proximity with Biostatistician in randomization of patients using Proc Plan and assisted in statistical report writing and SAP preparation.
• Data validated by checking data distribution and by subsetting data.
• Successfully identified problems with the data, produced derived data sets, tables, listings and figures, which analyzed the data to facilitate correction.

Environment: SAS/BASE, SAS/ACCESS, SAS/MACROS, SAS/CONNECT, SAS/STAT, SAS/GRAPH, Oracle 8i, SAS/SQL, SAS/ODS, HTML, MS Office, UNIX

Confidential, St. Paul, MN

SAS Programmer

Responsibilities:

• As a SAS Programmer, involved in generation of Clinical data summary Tables/ Listings/ Graphs and Reports using SAS for Clinical Study reports for Phases II.
• Involved in creation of SAS datasets from Oracle tables by using SAS/Access, SAS/SQL for analysis.
• Support data management in data creation/ transfers, integrity checks and audits.
• Developed programming specifications for derived data sets, listing tables and summary tables.
• Involved in writing code using Base SAS & SAS/MACROS to extract, CleanValidate data from different data source.
• Participated in several CRF review meeting
• Created reports in PDF, RTF using SAS/ODS along with usage of Proc Report
• Efficient usage of arrays, macros and proc sql.
• Performed several validations for various datasets, Tables, Listings and Graphs both by manually checking and as well creating intermediate datasets.
• Responsible for analyzing data using SAS/STAT procedures, and preparation of Documentation, code and reports for handing over the project.
• Good experience in working with various procedures like PROC SORT, PROC MEANS, PROC SUMMARY, PROC UNIVARIATE, PROC FREQ, PROC TEST, PROC GPLOT, PROC GCHART.
• Responsible for Checking the completeness, accuracy and consistency of the data.
• Revision of test Scripts for the functionalities in compliance with 21CFR Part 11.
• Created and maintained the 21 CFR Part 11 Assessment.
• Involved in creating Clinical validation and derivation procedures using request provided by the Data Management Group and as per data validation document.
• Creating permanent formatted SAS data sets and developed reports using PROC REPORT, PROCTABULATE and DATA NULL for analysis.
• Modified existing SAS programs for facilitating migration from Mainframes to Oracle data engine.
• Writing and implementation of Unix Shell Scripts.
• Written programs using Base SAS, SAS/ Macros to extract clean, validate data from Oracle tables, created SAS Datasets in local SAS directory

Environment: BASE SAS v9.0, SAS ENTERPRISE GUIDE, SAS/MACROS, SAS/GRAPHS, SAS/STAT, Oracle Clinical, UNIX, MS OFFICE, SAS SQL.

Confidential, Atlanta, GA

SAS Programmer

Responsibilities:

• Performed Data cleansing and Integrity checks using SAS MACROS and DATA steps.
• Extracted data from excel, and prepared raw SAS datasets by using SQL pass-through and Proc Import.
• Derived analysis datasets from raw datasets using SAS data step and SAS procedures
• Created SAS data sets by extracting data from Oracle tables using SAS/SQL and SAS/ACCESS and prepared them for statistical analysis.
• Created new datasets from raw data files and modified existing datasets using Set,
• Merge, Sort, Update, and conditional statements.
• Performed Edit Checks for cleaning up the data in data management.
• Worked with presentation and reporting procedures like FORMAT, REPORT, PRINT, SORT, etc.
• Conducted and generated the Regression, Correlation studies and Analysis of Variance using PROC REG, PROC CORR, PROC ANOVA.
• Created SAS INDEX’S by importing workable crosswalk data into SAS from various data types and formats like metadata, MS Excel and MS Access files, delimited text files, and comma separated values (CSV) files.
• Utilized SAS PROC SQL Pass through facility for data extraction, location and retrieval from the Oracle database.
• Generated output files in text format, HTML & PDF format using SAS ODS.
• Create Edit Checks to verify the accuracy of the data.
• Designed and created SAS macro based system to perform the SDTM validation Checks on the SDTM datasets.
• Developed Programs using SAS MACROS and SAS Base Procedures.
• Used SAS procedures like Transpose, Summary and contents.
• Was involved in validation of tables, listings and datasets using procedures like PROC COMPARE, PROC FREQ, PROC MEANS, PROC FREQ, PROC ANOVA.
• Used Dynamic Data Exchange (DDE) feature of SAS for importing and exporting of data from and into SAS, MS Access and Excel.

Environment: SAS 9.0, Base SAS, SAS/Macro, SAS/STAT, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS

Confidential, Hawthorne, NY

SAS programmer/analyst

Responsibilities:

• Designed reports for key health care modules like administration ip billing op billing and pharmacy billing as per the requirements of the higher authorities
• Created reports for finding out the load balance of the patients for particular time intervals for analysis of business
• Converted ms sql server data tables into SAS data files using SAS sql and uploaded SAS data files into ms sql server tables using proc dbload
• Imported the data into SAS from excel spreadsheet, and various delimited files using proc import to generate reports as per the directions of the higher management
• Generated reports using proc tabulate, proc report, data null, SAS arrays, proc sql, and SAS macros
• Extracted data from MS SQL Server using SQL pass through facility and generated ad-hoc reports
• Tested and debugged SAS programs against the test data
• Processed the data in SAS for the given requirement using SAS programming concepts
• Imported and exported data files to and from SAS using proc import and proc export from excel and various delimited text based data files such as .txt (tab delimited) and .csv (comma delimited) files into SAS datasets for analysis
• Used statistical analysis procedures in the generation of reports periodically for analyzing the business using SAS stat procedures such as regression univariate, correlation, and anova
• Utilized procedures such as proc access, proc sql and proc dbload in SAS/access to retrieve the data into SAS from MS SQL Server database in data transformation and manipulation process, extensively used procedures like SQL, transpose, tabulate, copy, cport, cimport, sort, datasets, dbload etc

Environment: SAS/base, SAS/stat, SAS/graph, SAS ods.SAS/macros, SAS/access, ms-office