SUMMARY

• Certified SAS Programmer with about eight years of programming experience with SAS 8, 9.0, 9.1.3, 9.2 in Mainframe, Windows and UNIX Environments.
• Extensive programming experience in SAS tools like BASE/SAS, SAS/SQL, SAS/MACROS, SAS/ACCESS, SAS/ODS.
• Experienced in Base SAS procedures such as PROC FREQ, MEANS, SUMMARY, UNIVARIATE, FORMAT, IMPORT, EXPORT, REPORT, TABULATE, TRANSPOSE, DATASETS, COPY, PRINT and SQL.
• Possess extensive knowledge in sas tools like SAS ENTERPRISE GUIDE, SAS ENTERPRISE MINER, SAS INFORMATION STUDIO.
• Performed Data management like Merging, concatenating, interleaving of SAS datasets using MERGE and SET statements in DATA step and PROC SQL.
• Experienced in using SAS to read, write, import and export to other data file formats, including delimited files, Microsoft Excel, Access files.
• Worked primarily in the domain of Pharmaceuticals, Insurance and Health Care.
• Involved in Phase I, Phase II, Phase III of Clinical Trials and has working knowledge of Phase IV.
• Has great understanding and working knowledge of Good Clinical Practice (GCP), Code of Federal Regulations (21 CFR Part 11), eCTD and FDA regulations.
• Highly knowledgeable of Clinical Data Interchange Standards Consortium (CDISC) Version 2 and 3, SDTM, ADaM and International Conference of Harmonization (ICH) guidelines
• Has knowledge of Integrated Summaries of Efficacy (ISE) and Integrated Summaries Safety (ISS)
• Experienced at preparing reusable components and SAS Macros for automation of the application
• Has thorough knowledge in Statistical Analysis Linear Regression, Descriptive Statistics, Factorial ANOVA, Regression Analysis, etc.
• Strong experience in developing Test Plans, use cases, Test cases using requirements and design documents while specifying Testing Overview, Approach, Strategy, Scope, Roles and Responsibilities.
• Experience includes establish strategic direction, methodologies and procedures for testing.
• Experienced in Mainframes Z/OS environment with COBOL, JCL, VSAM, GSAM, IMS DB/DC, DB2, MQ series.
• Worked with various Databases like Oracle, DB2, IMS DB, and Teradata.
• Extensive knowledge in SQL, PL/SQL.
• Very knowledgeable with tools like ENDEVOR, XPEDITER, File - Aid, QMF, SPUFI.
• Received a “Pat-on-the-back” business award for Targit-6 project for outstanding performance.
• Received a“Feather-in-a-cap”award for the best practices, proactive interaction with the client and process improvement.
• Has a strong ability to interact with business knowledge experts to understand, and in some cases help define business functional needs
• Has the ability to work as a team as well as to perform individually
• Has exceptional problem solving skills for delivering useful and prudent solution. A quick learner with an eye for detail and excellent analytical and quantitative skills.
• Excellent written and verbal communication skills, self-starter and good team player.

TECHNICAL SKILLS

Clinical Trials: Phases I, II, III &IV, NDA Submissions and FDA Approvals

SAS: SAS v8, v9.1, 9.2. Base SAS, SAS/Macro, SAS/Access, SAS/SQL, SAS/STAT, SAS/Connect, SAS/GRAPH.

Languages: C, C++, MS Visual Basic5.0/6.0, SQL

Database Platforms: Oracle 8/9/10g, PL/SQL, MS SQL Server, DB2, DB2/400 and MS Access

OS: LINUX, IBM AS/400, MS Windows 95/98/NT/2000, SCO UNIX, Sun Solaris

Others: MS Office, UNIX shell scripting.

PROFESSIONAL EXPERIENCE

Confidential, NJ

Senior SAS Programmer

Responsibilities:

• Participation in the meetings with SMEs to gather high level requirements for the projects.
• Analyzing the requirements and preparing the high level and low level design documents.
• Writing SAS programs using PC SAS to do data transformations, validations of the data and to generate sas reports.
• Create summary reports and graphs to the users.
• Worked on adhoc requests to change the existing sas code and macros.
• Worked on standardizing and productionising the existing sas jobs using cybermation scheduler.
• Wrote UNIX shell scripts to call SAS programs.

Environment: SAS 9.2, SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, Windows xp, UNIX, OS/390, COBOL, JCL.

Confidential, Columbia MD

SAS Programmer

Responsibilities:

• Experience in working with healthcare data (claims, eligibility, prescription plan, pharmacy plan) using SAS and SQL.
• Worked on analyzing large datasets and complex pharmacy claims datasets.
• Performed data editing, cleansing, manipulation and analysis for various SAS programs.
• Generated Adhoc-reports and key analytical reports on daily, weekly, monthly basis which focused on pharmacy data.
• Hands on experience using SAS Enterprise guide 5, SAS Enterprise guide 4.3, UNIX and PC platform.
• Performed statistical analysis and data analysis of claims data.
• Extensively used Data Null and SAS procedures such as REPORT, TABULATE, FREQ, MEANS, SUMMARY and TRANSPOSE for producing ad-hoc and customized reports and external files.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS tools like SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT, and SAS/GRAPH.
• Worked on fixing programs and change existing code to ensure smooth run of the programs that are scheduled -maintained programs in SAS using SAS tools for Windows and UNIX in a user support environment.
• Program documentation on all programs, files and variables for accurate historical record and for future reference
• Maintain, Develop and Support the routine activities of Hercules communication engine (team specific database).
• Knowledge in using Visual Analytics.
• Running edit checks and performing data validations, investigating and troubleshooting program and data errors using SAS and SQL in Toad.
• Participated in SAS deployment and Release Management (RM) activities/processes.
• Extensively used SAS/ Macro facility to provide reusable programs that can be conveniently used time to time.
• Experience in extracting data and creating SAS datasets from various sources like Oracle database, db2 database, Excel and flat files using Import techniques.
• Created reports using style format (pdf, rtf, html) using ODS statement and Proc report
• Involved in frequent interactions with the business users and SMEs to address development issues, prioritize and distribute workload.

Environment: SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, Oracle 9, db2 9.2

Confidential, Irvine, CA

SAS Programmer

Responsibilities:

• Provide statistical programming expertise in Phase I and Phase II study to conduct statistical analysis in order to confirm the safe dosing frequency, safety and efficacy.
• Used PROC LIFETEST to predict and study the timing of events, the efficacy endpoints of clinical trials such as patient survival time, time to disease progression, duration of patient response etc.
• Conversion of raw data into standard datasets as per CDISC SDTM and analysis/derived datasets using AdaM.
• Wrote excel specs, coded and validated CDISC- ADAM, SDTM data and TLG’s using SAS in accordance with client SOP’s.
• Generated ADAM specifications under the guidance of project statistician.
• Developed SOP’s and documentation support in accordance with 21 CFR Part 11.
• Involved in development of CRT for Clinical trial analysis and Electronic submissions to FDA (21 CFR Part 11).
• Worked on creating TLG’s and AdaM datasets with respect to safety and efficacy data.
• 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 converting irregular dates (non-standard form) into ISO 8601 date format.
• Validated and Performed CRF review, design and quality check.
• Develop and implement clinical trial reporting systems in support of electronic regulatory submissions.
• Produced data listings, summary tables and graphics for interim and final analyses and publications.
• Verified accuracy and integrity of Clinical data by performing validation checks written in SAS and investigate data related errors, outliers, and missing values.
• Provided input into planning documents such as validation plan, statistical analysis plan, and TFL templates as per AdaM Standards.
• Generated necessary outputs required for CSR’s (clinical study reports), integrated summaries and electronic submissions.
• Worked on different phases of clinical trials data like Demographic data, adverse event, serious adverse events, laboratory data, physical and vital signs.
• Wrote independent SAS programs to create, validate SDTM and AdaM datasets for Phase II, III studies.
• Worked on extracting and collecting the data from different database like Oracle clinical, Informix and RAVE.
• Hands on experience in writing SAS Macro exclusively for visits.
• Optimized performance using Data Validation and Data Cleaning on Clinical Trial Data.
• Participated in a pilot project involved in the development of CDISC SDTM and AdaM datasets.
• Worked on Data mapping from Existing Raw data to CDISC SDTM Standards, data mapping from SDTM to AdaM Domains.

Environment: SAS 9.2 on UNIX with following modules, SAS/BASE, SAS/MACRO, SAS/ODSSAS/GRAPH, SAS/SQL, SAS/ACCESS, SAS/CONNECT, SAS/STAT, MS Office, WINDOWS, UNIX.

Confidential, NY

Clinical SAS Programmer

Responsibilities:

• Produced RTF, PDF and HTML formatted files using SAS/ODS to produce ADHOC reports for presentation and further analysis.
• Worked on Data mapping from Existing Raw data to CDISC SDTM Standards, data mapping from SDTM to AdaM Domains.
• Designed data specifications for analysis datasets following algorithms and derivation procedures in SAP.
• Good understanding of standards of specific to clinical trials such as WHO drugs and MedRA.
• Produced statistical tables, listings, and figures (TLF’s) for individual and integrated reports involving both safety and efficacy analysis based on the SAP, specifications and CRF.
• Involved extensively in Data Integration (ISS/ISE) and Phase I-IV clinical studies.
• Worked closely in various teams with medical writers, data-managers, clinical monitors, statisticians and fellow programmers.
• Provided input into planning documents such as validation plan, statistical analysis plan, and TFL templates.
• Generated necessary outputs required for CSR’s (clinical study reports), integrated summaries and electronic submissions.
• Developed SAS programmable edit checks to assist in data review as needed. Answered QA audits in an accurate and timely manner.
• Involved extensively in the preparation of Data definition tables, Define.pdf and other project management documents.
• Provided programming support for Post submission FDA requests in a timely manner.
• Generated highly customized reports using SAS macro facility, Proc Report, Proc Tabulate, and Proc SQL.
• Created SAS datasets from Microsoft Excel files using Proc Import and Import Wizard.
• Generated Tables, Listings and Graphs using various procedures like PROC FREQ, Proc Report, Proc Tabulate PROC UNIVARIATE, Data null, Proc Plot, and Proc Gplot SUMMARY and also provided descriptive statistics using PROC Means
• Retrieved tables from Oracle Clinical databases with PROC SQL using ‘Pass through Facility’.
• Used Macros to produce Data Definition Documents (DDDs) for NDA submission and annotated Case Report Forms (aCRF) to the dataset. Merged electronic data with the CRF.

Environment: SAS/Base, SAS/Access, SAS/STAT, SAS/GRAPH, PL/SQL, Oracle 8.

Confidential, Indianapolis, IN

SAS Consultant

Responsibilities:

• Developed and maintained existing SAS programs that were used for creating various reports, lists, etc. for regulatory submissions.
• Developed standard reports for safety data including adverse events summaries for IND (Investigational New Drug) and post-marketing safety reports.
• Developed data specification for Phase I and III clinical trials
• Generate the required SAS datasets from large database using Sorting and Merging techniques.
• Existing SAS Macros were used to generate text files on a weekly schedule.
• Generated Customized Reports using the Data Null technique for regulatory submissions.
• Proc SQL, Proc Import was used to retrieve data from databases like Oracle, and Excel.
• Displayed reports, lists in Intranet website. These online reports were used by other groups. Reports and lists were updated weekly or monthly base on schedule using SAS - output delivery system ODS.
• Performed relevant statistical analysis of surveys and economic data captured during Clinical Trials.
• Maintained appropriate study application documentation. Provided SAS programming and statistical support to Clinical studies
• Created and maintained SAS Datasets that are extracted from an Oracle Database.
• Accessed External Excel files, Stored and Retrieved SAS data sets moving data through multi platforms.
• Responsible for developing new SAS programs and modifying existing SAS programs.
• Converted MS-Word documents, MS-Excel, Oracle tables into SAS data sets.
• Wrote Edit Check programs using Oracle, SQL for Data validation before using for final analysis.
• Developed reports using PROC REPORT, PROC TABULATE and DATA NULL .
• Developed SAS macros for data cleaning and Reporting and to support routing processing.
• Created SAS Macros and SAS Graphs. Used Proc REPORT to generate reports
• Read data from Oracle, Excel and flat files into SAS software. Developed SAS code to clean the invalid data from the database.
• Creating Summary Reports and Tabular Reports. Used SAS/STAT software for Statistical Analysis, procedures and reports.

Environment: SAS, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, Oracle8

Confidential, Rochester, MN

SAS Consultant

Responsibilities:

• Produced data listings, summary tables and graphics for interim and final analysis and publications.
• Provided data in SAS transport files, and other appropriate deliverables and documentation for regulatory submissions.
• Participated in maintenance of software applications. Identifying enhancements and new features. Participated in requirement reviews.
• Performed validation programming on clinical trial data using SAS MACROS.
• Created base macros to run reports. Creating standard reports to use across studies and creating base programs to set up data.
• Helped Statistician in creating graphs using G-Plot.
• Performed Data entry and conversions, data validation and corrections, uploading/ downloading data from/to a PC.
• Extensive use of PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC MIXED, PROC REPORT, PROC TABULATE.
• Tested and debugged against the test data.
• Used SAS for pre-processing data, data analysis, generating reports, statistical analysis, and graphs.
• Responsible for locating appropriate databases for projects.
• Responsible for implementing and monitoring clinical research trials, tracking study progress, and ensuring data integrity.