SUMMARY

• Base SAS Certified and has 7 years of extensive experience as SAS programmer, SAS Analyst in Clinical/Pharmaceutical and Medical Technology Industries for data analysis, coding and implementation in Windows and UNIX environments.
• Fluent with the applied aspects pertaining to SAS Programming using SAS/BASE, SAS/MACROS, SAS /SQL, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/ACCESS, SAS/CONNECT.
• Knowledge of collecting client's requirements and accessing datasets from the client's data warehouse using Base SAS.
• Proficient in Importing or extracting data using Import techniques to create SAS datasets from various sources like Relational databases by connecting SAS System to database systems, such as Microsoft SQL, Oracle, Excel, flat files and Exporting data to generate dynamic reports in HTML, RTF, XML, Excel, and PDF formats by using SAS/ODS .
• Extensive experience in Statistical Analysis, Reporting and Clinical Data Management involving analysis, design, development, testing and validating the applications.
• Extensive experience in Programming with procedures like PROC DATASETS, PROC PRINT, PROC APPEND, PROC GPLOT, PROC GCHART, PROC COMPARE, PROC IMPORT, PROC EXPORT, PROC FORMAT, and PROC COPY.
• Expertise in using SAS report generating procedures like PROC REPORT, PROC SQL, PROC TABULATE, PROC TRANSPOSE, PROC SUMMARY and Optimized performance using Data Validation and Cleaning on Clinical Trial data using statistical procedures like PROC FREQ, PROC ANOVA, PROC MEANS, and PROC UNIVARIATE.
• Proficient in drawing flowcharts indicating the input data sets, sorting and merging techniques to get the required report.
• Developed SAS codes with SAS/MACRO facility, used SAS/MACROS sensibly to improve the reusability of the codes. Tested and debugged existing macros and also produced standard edit check macros to perform standard data checks.
• Knowledge of using SAS 9.2/ENTERPRISE GUIDE in Data Analysis, understanding of RDBMS (Oracle 8/8i/9i, 10g), PLSQL, MICROSOFT EXCEL, POWERPOINT. PROGRAMMING IN C and UNIX.
• Experience in CDISC standards and transforming raw data to create datasets following these standards.
• Knowledge of drug development process with strong experience of statistical methodology, data analysis, summarization, reporting and submission for all four phases of Clinical Trials: Phase I, Phase II, Phase III and Phase IV (Post - market study).
• Experience in Clinical Data Analysis in accordance with guidelines and providing Clinical Study Reports.
• Proficient in working with clinical trial data like demographic, AE, SAE, Lab, Vital Signs and CRF/e-CRF, other essential documents in clinical Research.
• Proficient in performing QC on programs by developing Quality Control (QC) procedures.
• Experience in supporting multiple projects under deadlines often with competing priorities and complexities by applying critical thinking, problem solving, and decision making skills to optimize solutions.
• Detail-oriented with significant organizational and program documentation skills. Communicated and collaborate efficiently with cross-functional teams.

TECHNICAL SKILLS

SAS Tools: SAS9.1.3,SAS9.2,SAS/BASE,SAS/MACROS,SAS/SQL,SAS/STATSAS/GRAPH, SAS/ODS, SAS/ACCESS, SAS ENTERPRISE GUIDESAS/CONNECT

SAS Procedures: CONTENTS, PRINT, SORT, IMPORT, EXPORT, DBLOADDATASETS, TRANSPOSE, PRINTTO, FORMAT, SQL, REPORTTABULATE, MEANS, FREQ, SUMMARY, ANOVA, CHART, PLOTGPLOT, GCHART.

Databases: ORACLE 8/8i/9i, 10g, ORACLE CLINICAL

Operating Systems: UNIX, LINUX, WINDOWS 98/XP/2000/NT

Languages: SAS 9.2, SAS ENTERPRISE GUIDE, C, PL/SQL, PERL

Office Tools: MS-OFFICE, WORD, EXCEL, POWERPOINT, HTML

PROFESSIONAL EXPERIENCE

Confidential, Mission Bay, CA

Clinical trial Programmer

Responsibilities:

• Successfully implemented SAS for regular clinical data collection and data analysis.
• Reviewed protocols, case report forms and statistical analysis plans for clinical trials.
• Worked with my team for designing and generating analysis datasets, tables, listings, and graphs (TLG) from clinical trial data.
• Created and derived datasets using SAS/BASE, SAS/STAT, and SAS/GRAPH software.
• Created edit check programs as a database clean-up tool for the Data Management team.
• Used many options for Importing Excel into SAS Import Wizard, DDE, PROC IMPORT, via a CSV file, LIBNAME Statement, via a TXT file.
• Performed reading and writing XML files from SAS by reading XML document into SAS dataset, creating XML files from SAS PROCs using ODS, converting a SAS dataset into XML.
• Performed data analysis on the datasets using PROC UNIVARIATE, PROC MEANS, PROC FREQ and PROC ANOVA. Validated datasets using PROC COMPARE.
• Implemented clinical data acceptance testing procedure using edit check macros for creating an RTF file with minimum SAS programs and maintenance.
• Handled documenting and annotating CRF’s according to protocol.
• Prepared SDTM and ADaM-Version data sets as per CDISC standards.
• Actively involved in creating tabular reports with line sizes, page breaks, header message and bottom message using PROC SORT, PROC PRINT and PROC REPORT.
• Executed sorting and merging of data and generated CRT's, tables, listings and graphs using SAS/BASE, SAS/STAT, SAS/GRAPH and SAS/SQL.
• Created SAS/MACROS and established MACRO programs for data cleaning, validation, analysis and report generation using new and existing macros. Generated macros for data analysis to produce safety and efficacy reports. Used PROC SQL to create the macro variables.
• Generated output in various formatted files such as Excel sheets, RTF, and HTML using SAS ODS.
• Worked with different clinical trial data like Demographics, Adverse Event, Laboratory Examination, ECG and Vitals data.
• Used various strategies to develop program and test data review listings in SAS and reporting tool for data review purposes.
• Worked extensively in e-submission, preparing transport files and define document as per FDA guidelines.
• Executed increasingly complex or multi-protocol projects and acted as a Statistical Programmer to clients and internal departments. Managed off-shore programming resources.

Environment: SAS/BASE, SAS/SQL, SAS ENTERPRISE GUIDE, SAS/GRAPH, SAS/STAT, SAS/MACROS, SAS ODS, UNIX, SAS9.2, SAS9.3.

Confidential, Mansfield, MA

Clinical Application Programmer/Analyst

Responsibilities:

• Involved in clinical trial studies, data migration/extraction of data from flat files, SQL tables and SAS datasets.
• Created CRT (Case Report Tabulations) datasets using CDISC standards for submissions to the FDA.
• Extensively used Dynamic Data Exchange (DDE) for importing data in Excel sheets into SAS.
• Extracted, validated and generated SAS data sets from Oracle; applied ‘SQL Pass through Facility’.
• Analyzed PhaseI, Phase II and Phase III Clinical Trials.
• Performed statistical analysis, wrote SAS code for Data Management and reporting, and performed validation, including testing SAS code.
• Produced Tables/Listings for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Communicated with Statisticians and Bio-Statisticians to discuss about various SAP related issues and made presentations to discuss about various possible changes in it.
• Maintained appropriate study application documentation.
• Used the SAS MACRO facility to produce weekly and monthly reports.
• Performed Data Validation and Data Cleaning on Clinical Trial data.
• Created and maintained SAS Datasets that are extracted from an Oracle Clinical Database.
• Created SAS Customized Reports using DATA NULL technique for FDA regulations.
• Produced accurate, precise tables and listings for Clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) Part11, FDA and other regulatory compliance.
• Developed routine SAS macros to create tables and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Performed SAS programming using techniques as SAS BASE, SAS MACRO, DATA MANIPULATION TECHNIQUES and STATISTICAL PROCEDURES (e.g., PROC MEANS, PROC FREQ, PROC REPORT).
• Extensively interacted with the functional users to understand the requirements on statistical methods and measures.
• Designed flowcharts indicating the input data sets and the techniques that would be used (sorting, merging, etc.) to get the desired output.
• Exposure to Data warehouse applications.
• Preliminary data validation (clinical data quality checks) is done on the clinical trial data using SAS/SQL.
• Produced data listings, summary tables and graphs for interim and final analyses and publications using different statements/functions/procedure for data manipulation.

Environment: ORACLE CLINICAL 4.x, SAS 9X, SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/MACRO, SAS/ACCESS, SAS ENTERPRISE GUIDE, SAS/ODS, UNIX, MS ACCESS, EXCEL.

Confidential, MA

SAS Programmer

Responsibilities:

• Conducted various graphs such as Bar Charts, Line Plots, Profiles Chart and Scatter Plots using SAS/GRAPH.
• Designed and implemented statistical reporting process for clinical data (Phase I and Phase II) analysis.
• Performed program documentation on all programs, files and variables for accurate historical record and for future reference.
• Created and maintained SAS programs to generate derived datasets and required summary reports.
• Defined various user defined formats using PROC FORMAT besides using different kinds of predefined INFORMATS and FORMAT statements.
• Quality assurance checks to support cleaning of clinical data using PUT statement and various PROC’s.
• SAS MACROS were extensively used in the creation of new programs as well as modification of existing programs to improve ease and consistency of results.
• Produced quality customized and ad hoc reports by using PROC TABULATE, REPORT and SUMMARY and also provided descriptive statistics using PROC MEANS, FREQ and UNIVARIATE.
• Used DATA NULL technique for producing highly formatted and highly customized reports.
• Produced RTF, MSWORD and HTML formatted files using SAS/ODS to produce ADHOC reports for presentation and further analysis.
• Conducted, documented and reported computer validation inspection in compliance with FDA Regulations (21 CFR), other regulatory compliance, data transmission and integrity check of the existing and in-house clinical trial systems.
• Developed Integrated Summaries of Safety and Efficacy (ISS/ISE) analysis reports across multiple studies.

Environment: LINUX, UNIX, WINDOWS XP, SAS V9, SAS/BASE 9.1.3, SAS/MACROS, SAS ENTERPRISE GUIDE, SAS/SQL, SAS/ODS, SAS/GRAPH, SAS/STAT

Confidential, NJ

SAS Programmer

Responsibilities:

• Document and Analyze results and set up reports containing respective conclusions, ideas and general guidance.
• Reviewing data definition tables for SDTM and derived data sets for assigned studies and provide comments.
• Developing programs to generate SDTM datasets from raw data collected on Case report forms (CRF’s) using CDISC standards.
• Experienced with the CDISC SDTM and ADaM models and transforming raw data into these standards.
• Creation of Safety and Efficacy Evaluation Tables and Listing as per Statistical Analysis Plan.
• Tables and Listing Validation as per the Standard Operating Procedure (SOP).
• Analytical Dataset (VS, MH, AE etc.,) creation as per ADS Specification, Data Quality Check and Validation. Involved in creation of Analytical Dataset, Generation of SDTM Compliance SAS Dataset, Generation of Tables and Listing, Validating, Mapping and conversion of Non- CDISC SDTM Dataset to CDISC SDTM Dataset as per SDTM IG 3.1.1.
• Provided programming support to produce CDISC compliant databases (e.g. STDM, ODM, ADAM) for regulatory submissions.
• Creating Annotated CRF’s and generation of SAS Reports for project team lead review.

Environment: SAS9.1.3, SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/ACCESS, MICROSOFT OFFICE APPLICATIONS, WINDOWS 2000, WINDOWS NT, UNIX.

Confidential

SAS Programmer/Analyst

Responsibilities:

• Understanding study Protocol, SAP, CRFs. Retrieving the CRF data into SAS from the ORACLE (CRF databases) using SAS/ACCESS and SAS SQL procedures.
• Generated graphics for reporting purposes using SAS/GRAPH, PROC TABULATE etc.
• Created ad-hoc reports using various SAS PROCEDURES, SAS/GRAPH and SAS/STAT for the functional specification.
• Involved in data manipulation by MERGING, APPENDING, CONCATENATING, SORTING datasets and also data migration from one platform to another to be used for further clinical analysis.
• Extensively used DATA NULL, PROC FREQ, PROC TABULATE, PROC REPORT, PROC MEANS, PROC SUMMARY, PROC CONTENTS and PROC COMPARE.
• Investigated missing data and data inconsistency in SAS data sets. Developed edit-check programs to clean invalid data from the database.
• Created external files mainly RTF and HTML reports using SAS Output Delivery System (ODS).

Environment: SAS/BASE V8, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ACCESS, ORACLE, SAS ODS, WINDOWS and MS EXCEL.

Confidential

Clinical SAS programmer

Responsibilities:

• Utilized SAS PROCEDURES and other SAS applications for data updates, data cleansing and reporting.
• Preparing and Classifying Clinical Trial Data.
• Importing Relational Databases and Clinical Data Management Systems.
• Transforming Data and Creating Analysis Data Sets.
• Creating Tables and Listings and Common Clinical Trial Graphs.
• Performing Common Analyses and Obtaining Statistics using PROC FREQ and PROC UNIVARIATE.
• Exporting Data to the FDA using the SAS EXPORT and creating XML Files.
• Became proficient in SAS BASE, SAS ODS, SAS SQL etc.

Environment: SAS/BASE, ORACLE CLINICAL, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/SQL, SAS ODS, ORACLE, WINDOWS.