SUMMARY

• Certified SAS programmer with over SEVEN years of SAS programming experience providing statistical programming support for multiple clinical research projects in pharmaceutical and healthcare industries.
• Experienced and Sound knowledge of working with Health Claims Data.
• Knowledge of Medical codes i.e. ICD10, HCPCS, CPT and Medical Claims Processing systems.
• Experience with version9: Base SAS, SAS/Macros, SAS/SQL, SAS/STAT, SAS/Access, SAS/GRAPH, SAS/STAT and SAS/ODS in Windows and UNIX.
• Conducting, documenting and reporting computer validation inspections in compliance with 21 CFR Part 11, data transmission and integrity check for the existing and in - house Clinical Trial Systems.
• SAS programming experience with selection of appropriate 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).
• Created CRT’s (Case Report Tabulations) and annotating Case Report Form (CRF’s) using CDISC standards for submissions to the FDA. Used XML for data formatting that fits the FDA’s strategies for electronic submissions.
• Good working knowledge of data summarization such as demographics, adverse events, laboratory data, physical, ECG, Vital signs etc., and efficacy endpoint analysis.
• Hands-on experience in using SAS/ODS to generate different files including XML, RTF, MS Excel, PDF and HTML.
• Wrote CDISC standard dataset specifications and follow specifications to create SDTM version 3.1 and AdaM Version 2.0 datasets.
• Used SAS extensively to analyze clinical data from CRF’s, creating SAS data sets for the purpose of analysis and report writing for clinical trials (Pre-clinical through Phases IV), generating efficacy and safety reports, creating datasets and generating reports using PROC Tabulate, PROC Report, Data Null, SAS arrays, PROC SQL and Macros, and verified and documented programs.
• Generated ADAM specifications under the guidance of project statistician.
• Good Experience in understanding the PROTOCOLS and CDISC Process (SDTM and ADAM Models).
• Provide statistical programming expertise from Phase I to Phase IV therapeutic studies to conduct statistical analysis in order to confirm the safe dosing frequency, safety and efficacy.
• Worked on Data mapping from Existing Raw data to CDISC SDTM Standards, data mapping from SDTM to AdaM Domains.
• Expert in using PROC SQL, PROC REPORT, PROC ACCESS, PROC GPLOT, PROC GCHART, PROC FORMAT, PROC TABULATE, DATA MERGE, SORT to generate reports.

TECHNICAL SKILLS

Operating Systems: MS-DOS, Unix, Windows NT/2000/2003 Server/XP/Vista, OS/390

Languages: COBOL, VS COBOL II, JCL, VB, C, C++, JAVA, SQL, PL/SQL, UNIX SHELL SCRIPTING, HTML SCRIPTING, JAVA SCRPTING.

SAS Tools: Base SAS, MACROS, ACCESS, SQL, GRAPH, ODS, SAS ENTERPRISE GUIDE, SAS ENTERPRISE MINER, SAS INFORMATION STUDIO.

Database: Oracle,DB2,IMS DB, VSAM, GSAM,MS Access

OLTP: CICS, IMS DC, TELON

Mainframe Tools: File-Aid, Endevor, JCL, QMF, SPUFI, Xpediter

Utilities: TSO, ISPF, IBM Utilities.

Domains: Insurance, Health Care and Pharmaceutical

Other Skills: Team Leading, Reviews, test planning and conducting vertical audits

PROFESSIONAL EXPERIENCE

Confidential, Tampa, FL

SAS Developer

Responsibilities:

• Implemented waterfall method of Software Development Life Cycle (SDLC) methodology for design, development, and implementation and testing of various SAS modules.
• Performed Impact Analysis on various Enterprise Data Management related SAS programs.
• Designed Technical Specification Documents (TSD) for impacted SAS processes.
• Involved in Remediation/Development of multiple SAS Programs impacted by ICD10.
• Performed enhancements to PL/SQL packages/procedures.
• Hands on experience using Enterprise Guide, X-Win 32 2012, SAS 9.3 for LINUX and UNIX platforms to execute various SAS modules.
• Proficient in using PL/SQL, SQL Developer, Toad for Oracle/db2 tools to perform data analysis.
• Preparation of test data and verification of test results in QA/UAT environment.
• Involved in creating regulatory reports supporting Medicare and Medicaid plans for various states.
• Sound understanding of Industry standard diagnosis and procedures codes like HCPCS, CPT, and ICD9/ICD10.
• Worked with multiple IT stakeholders to understand the specific functionalities associated with each impacted process/application.
• Worked with numerous business departments and third party vendors to validate the remediated files/processes.

Environment: SAS/BASE, SAS/MACROS, PL/SQL, SQL*Loader, SQLPlus, SQL Server, UNIX, TOAD, SAS/ACCESS, SAS/SQL, Oracle 9, db2 9.2

Confidential, Northbrook, IL

SAS Programmer

Responsibilities:

• Responsible for developing SAS programs for the analysis of the data following the information stated in Analysis Plan.
• Worked with various Medicare claims files like In Confidential t, Out Confidential t, Prescription drug, Physician for CMS (Centers for Medicare and Medicaid Services) which were 5% random samples drawn with out replacement.
• Created Comparative effectiveness research public use files (CER-PUF) and deliver the Medicare claims files in the de identified form to CMS which will be useful to the public for comparative effectiveness research.
• Performing Risk Analysis on the PUF datasets combined with the re-identification.
• Using HIPAA standards set for protecting PHI (Protected Health information) for de-identification of the PUF datasets so that the information available to researchers is not IIHI(individually identifiable health information).
• Estimating the identification risk, conducting Re-identification analysis by using inside and outside intrusion after safe harbor treatment.
• Reading data from the external source files such as Comma separated files, mainframe files (EBCDIC) and tab delimited files.
• Created reports using ODS into formats such as RTF, HTML and ODS TAGSETS to create XLS, XML.
• Interpreting and summarizing the analytical findings.
• Identifying the data sources to develop the Voluntary disenrollment measure from CMS’ databases such as Medicare beneficiary Database (MBD), Enrollment Database (EDB) .
• Worked on the SAS code to develop the measure of voluntary disenrollment for Part C and part D and SAS code to identify the involuntary disenrollment.
• Worked on part D report Card analyses to produce the star rating values for all the contracts that offer Part D coverage.
• Working on SAS code to import the CME (Common Medicare Environment) data to SAS from EBCDIC format (extracted from Mainframes) and develop the measures for monitoring the Administrative functions.

Environment: SAS 9.2, SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, Windows xp.

Confidential, Round Lake, IL

Clinical SAS Programmer

Responsibilities:

• Created SAS datasets by taking database tables as input datasets using SAS/ACCESS SQL Pass Through Facility
• Performed edit check programming for data cleaning using SAS.
• Created tables, listings, and graphs using Base/SAS and SAS/GRAPH
• Developed SAS programs for mapping raw datasets into SDTM domain datasets.
• Validated the Transformed datasets for CDISC compliance.
• Analyzed dose-response curves using PROC GLM AND PROC GPLOT
• Analyzed reference and the test responses using PROC FREQ using Fisher’s exact test option.
• Analyzed data from the lab reports and vital signs using PROC GLM procedures.
• Analyzed descriptive statistics of demographic data using procedures like FREQ, MEANS, TABULATE, UNIVARIATE, SUMMARY, CORR, REG.
• Created adverse event (AE) reports and concomitant medication summaries using PROC TABULATE.
• Prepared final analysis datasets from raw datasets that are CDISC compliant.
• Graphical reports of the results were created using PROC GPLOT, PROC ANNOTATE and PROC GCHART
• Generate customized reports and listings by modifying the existing SAS MACROS.
• Performed validation of the derived variables, reports, and listings.

Environment: SAS 9, SAS/BASE, SAS/GRAPH, SAS/STAT, SAS/SQL, SAS/MACRO, Windows, UNIX.

Confidential, Madison, WI

Clinical SAS Programmer

Responsibilities:

• Used SAS and SAS tools on the Clinical trials data to perform sorting and merging to prepare and validate data.
• Created and extracted Clinical data tables from Oracle Clinical and to SAS using SAS tools like SAS/ACCESS, LIBNAME engine.
• Ensured quality of dataset at the protocol level while working to deliver competitive advantage and cost efficient results.
• Extensively worked on SAS MACRO programming.
• Made extensive use of PROC IMPORT, SAS/ACCESS to Pc files for importing external files of MS EXCEL and ACCESS format.
• Worked on Pivot tables and VBA to write macros in Excel.
• Documented the mapping specification rules and created a specification document.
• Transformed raw data in to SDTM domain datasets by mapping process.
• Created and validated specifications for SDTM and ADaM transfer purposes
• Created Analysis datasets referring to the specifications provided according to the CDISC standards
• Create Define.PDF for SDTM datasets and ADaM datasets.
• Created customized reports by using PROC TABULATE, PROC REPORT, and PROC SUMMARY and also provided descriptive statistics using PROC MEANS, PROC FREQ, and PROC UNIVARIATE
• Generated various graphs using SAS/GRAPH
• Created demographics table using PROC TABULATE and PROC REPORT
• Involved in creating transport files as per the submissions to the FDA.
• Created Excel PIVOT tables by using the output from SAS and wrote VB scripts.

Environment: SAS 9, SAS/BASE, SAS/GRAPH, SAS/STAT, SAS/SQL, SAS/MACROS, SQL, UNIX, Windows.

Confidential, Princeton, NJ

SAS Programmer

Responsibilities:

• Provided programming support in compliance with relevant SOPs and working practices. Extensive experience with the SAS programming in data step and with various SAS Procedures in Base SAS including thorough knowledge of SAS /SQL
• Main role in preparing the Gap Analysis report for migration by interacting with SME and clients.
• Performing the impact analysis to find the programs that needs to be changed.
• Extracting the data from IMS DB in to SAS files and working on the files to transform the data.
• Major use of Merge statement and procedures like TABULATE, SUMMARY, SORT, SQL, MEANS and COMPARE to meet the business specifications.
• Defined various user defined formats using PROC FORMAT besides using different kinds of predefined INFORMATS and FORMAT statements.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools - SAS/Base, SAS/Macros and SAS/Graph, SAS/SQL, SAS/Connect, SAS/Access.
• Extensive experience in creating, reviewing and validating analysis datasets according to Statistical Analysis Plan.
• Extensive experience in creating test programs, validating datasets for adhering to department guidelines.
• Extensively used SAS/MACRO facility to provide reusable programs that can be conveniently used time to time and to avoid number of programming lines of code.
• Made major use of SAS/ODS and HTML scripts to create the reports.
• Created SAS Customized Reports using the Data Null technique.
• Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provided descriptive statistics using PROC Means, Freq, and Univariate.
• Performed and Formatted HTML, PDF, RTF and XML reports, using SAS - output delivery system ODS.
• Wrote JCL to run the SAS Programs created in Mainframe environment.
• Responsible for modifying the existing SAS programs to change the functionality according to new business requirements.
• Developed and improved the efficiency of programs through the use of SAS/MACROS for calculating Money control totals.
• Preparing Unit Test plans and integrated test plans to continue with the testing process for the quality delivery of the product.

Environment: O/S 390(Operating System), SAS 8.2, SAS/BASE, SAS/MACROS, SAS/ODS, SAS/SQL, JCL, IMS DB, DB2.