SUMMARY:

Over 7 years of experience as a Clinical SAS Programmer in pharmaceutical and clinical research industry in Data analysis and reporting.

• Excellent experience with emphasis on design, analysis, development and implementation projects.
• Statistical programming related to design, programming, implementation, maintenance, and validation of Clinical trial information for the submission to the FDA during various phases.
• Working knowledge of data extraction from database and flat files as SAS views and datasets using SAS Access.
• Create or validate tables, listings/datasets by using SAS.
• Experience in developing and modifying reports based on Statistical Analysis Plan or creating an Ad Hoc reports by using TABULATE, REPORT and SUMMARY and also provide descriptive statistics using MEANS, FREQ, SQLand UNIVARIATE
• Experience in developing analysis of SAS datasets including specs for Tables, Listings, Graphs TLGs ,Reports, Output Delivery System ODS , ad-hoc Reports and Summaries as per requirements.
• Experienced in statistical modeling, ANOVA,Regression Analysis, Correlation, logistic regression, Time Series Analysis, Survival Analysis.
• Proficient in using other procedures: PROC PRINT, SORT, REPORT, APPEND, and TABULATE, PLOT, GCHART, IMPORT, EXPORT and DATA NULL and MACRO to produce SAS reports.
• Hands on experience on the SAS Functions, Statements, Data Set Options and System Options.
• Efficient in Reviewing Clinical Study Protocol, CRF Forms, and Data Analysis Plan documents.
• Programming dataset in CDISC Format SDTM Model 3.1 , manage CDISC database for several studies by strong understanding of CDISC SDTMmodels and experience in converting data to CDISC SDTM Standards.
• Program analyzed datasets in ADaM model create Table, Listings and Figures by using ADaM datasets.
• Familiar with Data Pre-processing and dataset preparation for particular statistical analysis, including data cleansing, validation, data integration, data transformation, data reduction.
• Proficient in developing and debugging SAS/MACRO to access, extract, modify, merge and analyze clinical data.
• Experience working with SAS 8.2/9.2/9.3 in Windows environment
• Experience in Healthcare, Pharmaceutical and Environmental Protection domains.
• Strong knowledge of ICH-GCP guidelines, 21CFR11, and CDISC, SDTM standards for regulatory submissions.
• Experience in clinical data management, data analysis and generate CRT, eCRT.
• Knowledge of creating all files, documents and analyses necessary to support electronic submissions in formats ISS, ISE.
• Ability to handle multiple tasks and work independently as well as in team.
• Demonstrated strong programming, leadership, and organizational skills by constantly meeting tight deadlines for clients.
• Sound work ethics, self-motivated, quick learner and the attitude to constantly strive to mould to the dynamic requirements of the competitive workplace.

TECHNICAL SKILLS:

SAS Tools: SAS Versions 8.2, 9.2, 9.3, Base SAS, SAS SQL, SAS MACROS, SAS DM, SAS STAT, SAS GRAPH,SAS ODS, SAS ACCESS, SAS CONNECT, ETS, ANNOVA

Databases: MS-Access, SQL, Oracle, Oracle Clinical

Languages: PL/SQL, HTML, C

Operating Systems: Windows 9x/2000/ XP, UNIX

Tools: MS Office Suite, MS Excel, Word, Visio, MedDRA, WHODrug.

EXPERIENCE:

Confidential

Position: Sr. SAS Programmer

Responsibilities:

• Developed and maintained programs using SAS tools for Clinical trials.
• Extracted data from database and involved in cleaning the data data cleansing using various edit check techniques.
• Extensive hands on experience with SAS programming and in data step with various SAS Procedures in BASE/SAS and SAS/STAT, including thorough use of SAS MACROS.
• Created Tables, Listings, and Graphs using various procedures like PROC REPORT, PROC TABULATE, DATA NULL , as per the requirements of clinical and data management department.
• Validated programs and wrote competing codes to re-check the statistical values of tables.
• Interacted with Data Managers, Statisticians, and CRA's in clinical research and development by providing programming support for the processing of clinical data.
• Produced highly formatted and customized reports using DATA NULL .
• Performed quality assurance procedures of other programmer's work, cross-validation of SAS programs, and debug complex programming codes by using DATA step.
• Performed extensive data analysis, statistical analysis using BASE/SAS Procedures like PROC SQL, PROC CONTENTS, PROC PRINT, PROC SORT, PROC APPEND and statistical procedures of SAS/STAT like PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC ANOVA, PROC REG, PROC CORR.
• Created safety and efficacy TLF-derived analysis reports using SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/MACRO
• Involved in programming of data tables and listings for Integrated Summary of Efficacy ISE and Integrated Summary of Safety ISS .
• Extensively used departmental macros and created when needed.

Environment: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH, SAS/ODS, SAS/ACCESS,SAS/STAT,SAS/REPORTS, MS Office, Windows.

Confidential

Position: Clinical SAS Programmer

Responsibilities:

• Validated datasets as required by the client to find the missing data and imported to SAS Environment.
• Extracted data from flat files, MS Excel and database and created SAS data sets using different SAS procedures and SAS/SQL Pass through facility.
• Generated Descriptive reports and analysis, basic listings, summary statistics tables, one-way frequency tables and graphs, and tabular or graphical distribution analysis.
• Developed validated and documented programs to create TLG's Tables, Listings and Graphs as per Statistical Analysis Plan SAP using SAS reporting procedures like PROC REPORT, PROC SORT, Graphic procedures like PROC GPLOT and analysis procedures like PROC MEANS and PROC FREQ.
• Computed several ad-hoc reports for safety and efficacy of the clinical studies, as per the specs that are provided by the Statisticians.
• Involved in preparing study results as well as ISS and ISE for FDA submissions using SAS.
• Developed and used SAS Macros programs to generate reports, tables and listings for clinical and bio-statistical review.
• Generated Ad-Hoc reports for further analysis using SAS tools.
• Collaborated with Bio Statisticians and representatives from clinical to regulatory to develop clinical trial reporting systems, tables, patient listings, case report form tabulations and derived datasets.
• Used SAS Analytics for Leverage optimization, project scheduling and simulation techniques to identify the actions that will produce the best results.
• Created SAS reports using the Data Null technique and Proc Report for NDA submission as per FDA regulations and company standards. Used PROC COMPARE to conduct quality control checks on files, tables and listing.
• Created transport files for FDA submissions, used MedRA and WHO dictionaries

Environment: Base/SAS, SAS/ACCESS, SAS/CONNECT, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ODS, SAS/MACROS, MS Access, Windows

Position: Data Analyst

Responsibilities:

• Developed programs using the Libname statement SAS Views to extract report error statistics
• Created Automated Turnaround documents for use as re-input to source
• Contributed to several JAD sessions with focus to eliminate bottlenecks form the system
• Used Microsoft Access and Excel to provide output analysis data
• Programmed reports for Management to use to find business logic problems, manual and automated keying problems
• Imported data from SQL Server and Excel to SAS datasets. Performed data manipulation by merging several datasets and extracted relevant information
• Used SAS datasets to create reports using Proc Print and Reports. Also used Proc Transpose, Proc Tabulate, Proc Import, Proc Freq and Proc SQL
• Used arrays along with Proc Means, Proc Summary and Proc Freq. Created drill-down HTML reports for the finance department using data from several sources
• Used SAS/DDE to call Excel VBA macros in reporting applications development
• Used SAS Macros to produce drill down capability for the reports
• Produced tables in Excel using ODS and Proc Tabulate as per the business requirements
• Performed detail analytics while producing financial reports so that the financial data is checked and are accurate
• Generated reports, tables, graph to identify market opportunities and recommended business strategies based on analysis of internal and external data sets
• Participated in full life cycle of model development: market research, statistical analysis, model development, and reports/presentations

Environment: SAS/BASE, SAS/ODS, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ACCESS, SAS/CONNECT, Windows NT Server, UNIX, Microsoft Office 2003, SAS/EG, MS SQL Server

Position: SAS Clinical Programmer

Responsibilities:

• Provide programming support for phase II III clinical trials.
• Created CRT Case Report Tabulations datasets using CDISC standards for submissions to the FDA.
• Perform and plan programming, planning, testing, and documentation of statistical programs for use in creating statistical tables,
• Listings, derived datasets, and control checks. Program the integration of databases from multiple studies or sources.
• Develop, implement and validate new process technologies, macros and applications.
• Perform Statistical analysis, data verification and entry, report results for Pharmaceutical Development department.
• Utilize SAS execute data processing and analysis for pre-clinical trial research.
• Produce analysis, tables and listings for a pharmaceutical based CRO.
• Validate tables, Analysis Datasets, Listings. Modify Status Reports.
• Involved in mapping data from source raw data and converted them to CDISC SAS compliant datasets using mapping specifications.
• Developed mapping specifications for CDISC SDTM data mapping and created Analysis metadata Specifications as per the requirements.
• Involved in creating and/or validating Derived datasets and Analysis Datasets using ADaM implementation standards.

Environment: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS in windows and UNIX environment.

Position: SAS Analyst

Responsibilities:

• Managed and analyzed large complex data sets and prepared documentation of research andprogramming methods, procedures, and standards
• Worked with other researchers in developing complex MACROS for manipulating clinical data.
• Prepare clinical data listings and summaries for statistical analysis and analyzed clinical data usingSAS system.
• Demonstrated ability in statistical analysis, research quantitative methods, analytic design, DataMining, decision support system.
• Produced quality customized reports by using PROC TABULATE, PROC REPORT, PROC SUMMARY, PROC MEANS, PROC FREQ and PROC UNIVARIATE
• Optimized performance using data validation and data cleaning.
• Documented the flow charts indicating the input data sets, sorting and merging techniques to get the required report
• Generated modifiable SAS code using SAS/ BASE and SAS/ MACRO facility.
• Ran weekly and monthly reports using SAS Macros.

Environment:SAS 9.X, SAS/BASE,SAS/MACRO,SAS/STAT,SAS/SQL, Oracle.