PROFESSIONAL SUMMARY:

• SAS certified Base Programmer with 6+ years of SAS Clinical Experience.
• Experience in handling complex processes using SAS/BASE, SAS/MACROS, SAS /SQL, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/ACCESS.
• Good experience in Clinical Data Analysis: analyzing clinical data, derived datasets, creating tables, generating listings, reports and graphs.
• Knowledge ofClinical Terminology and regulatory Guidelines
• Experience in cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset
• Expertise in transforming data imported from disparate data sources into analysis datastructures, usingSASfunctions, options, ODS, array processing, macro facility, and storing and managing data inSASdata files
• Experience in Data Manipulation procedures such asSAS Formats/Informats, Merge,Proc Append, Proc Datasets, Proc Sort and Proc Transpose
• Good understanding of regulatory requirements, NDA processes, from IND submission to FDA approval (in compliance with 21CFR Part 11). dis includes Clinical Trials (Phases I - IV), preparation of IND, NDA, safety reviews, adverse event report reviews and production of integrated safety and efficacy summary (ISS & ISE) for FDA submission
• Experienced in Base SAS procedures such as PROC FREQ, MEANS, SUMMARY, UNIVARIATE, FORMAT, IMPORT, REPORT, TABULATE, TRANSPOSE, DATASETS, COPY, PRINT and SQL.
• Performed Data management like Merging, concatenating, interleaving of SAS datasets using MERGE and SET statements in DATA step and PROC SQL.
• Good knowledge of Clinical Trials Data like Demographic Data, Adverse Events, Vitals, Laboratory Data.
• Experience in programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Good command in producing tables and listings with reporting using SAS procedures such as PROC REPORT, PROC TABULATE.
• Producing data in various output formats including HTML, RTF, PDF using ODS (output Delivery System).
• Performed Data Analysis and validation.
• Experience in Modifying existing SAS programs and creating new SAS Programs using SAS Macro to improve ease and speed of modifications as well as consistency of results.
• Experienced in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries, and Graphs
• Strong knowledge of Statistical Analysis Plan, Standard Operating Procedures, Protocols of clinical trials
• Experience in producing external files and reports employing various SAS statements and procedures, ODS, Proc Report, Proc Tabulate in Clinical Trials
• Experience in giving guidance to team as and when required
• Adaptability and ability and to understand job requirements, new methods, ideas, concepts, and technologies
• Experience with transforming data in various formats (excel, CSV, ASCII) intoSAS datasets
• Strong experience usingSAS/GRAPH to produce Graphs by employingSASprocedures such as Proc Gplot and Proc Gchart
• Expertise in transforming data imported from disparate data sources into analysis datastructures, usingSASfunctions, options, ODS, array processing, macro facility, and storing and managing data inSASdata files.
• Experienced in producing RTF, PDF, HTML and MS Excel formatted files usingSASODS facility.

TECHNICAL SKILLS:

Statistical Packages: SAS

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

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

Databases: MS-SQL Server, Oracle, MS-Access.

SASProcs: 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, New York

ClinicalSASprogrammer

Responsibilities:

• Involved in managing randomized phase II and IIIclinicaltrials data.
• Maintenance of large data sets, combining data from various sources in varying formats tocreateSASdata sets and/or ASCII files by using Set and Merge for generating Reports.
• Developed new or modifiedSAS programs to load data from teh source and create study specificdatasets, which are used as source datasets for report generating programs.
• Prepared new Datasets from raw data files using Import Techniques and modified existing datasets usingSet, Merge, Sort, and Update, Formats, Functions and conditional statements.
• Created complex and reusable Macros and extensively used existing macros and developedSASPrograms for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.
• Generated Tables, Graphs and Listings for inclusion inClinicalstudy reports and regulatory submission, Participated in preparing study results as well as ISS and ISE for FDA submissions usingSAS.
• Modified macros for report generation usingSASMacros as per teh statistician’s requirements.
• Developed efficacy and safety tables including Adverse Events table, Laboratory Shift table and Concomitant Medication tables.
• Generated summary reports, listing and graphs using procedures like PRINT, REPORT, MEANS, FREQ,
• Wrote programs inSASto generate reports, creating RTF, HTML listings, tables and reports usingSAS/ODS for Ad-Hoc report generation.
• Attended project team meetings, worked with Bio-Statisticians, Data Managers, andClinicalResearch Managers as appropriate. Reviewed and provided feedback for Data Integrity Plans
• Experience in data warehousing, ETL.
• Experience using J-review for SAS datasets.

Environment: SASBASE,SAS/STAT,SAS/MACROS,SAS/GRAPH, SAS/ACCESS, DB2, SAS/IDP, UNIX and Windows.

Confidential, Wayne, PA

SAS Clinical Programmer

Responsibilities:

• Wrote code using SAS/Base and SAS/Macros to extract clean and validate data from Excel file,Access Database, and Microsoft SQL server
• Data transmission and integrity check of teh SAS datasets
• Used procedures Proc Means, Univariate, Freq and Compare to identify outliers.
• Participated in supervision of data entry operations under teh guidance of Data Manager.
• Used Dynamic Data Exchange (DDE) feature of SAS for importing data into SAS from MS Accessand Excel.
• Graphical and html reports were generated on safety and baseline characteristics.
• Reports were generated in PDF, RTF and HTML formats using SAS ODS .
• Converted existing raw data into CDISC standards and reviewed CRFs to ensure consistency and adequacy in data in order to meet teh objectives defined in protocol.
• Provided technical support to teh clinical study teams.
• Used PROC REPORT with ODS to prepare custom reports.
• Data Analysis using SAS/STATS procedures such as FREQ, UNIVARIATE, TTEST.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS/Tools, SAS/Base, SAS/Macro and SAS/Graph, SAS/SQL, SAS/Access
• Produced quality customized reports by using TABULATE, REPORT and SUMMARY and also provided descriptive statistics using MEANS, FREQ, and UNIVARIATE
• Developed SAS macros for data cleaning and Reporting and to support routing processing
• Created electronic SAS datasets, such as SAS transport files
• Developed and maintained general-purpose and ad-hoc SAS programs/Macros for teh validation, Extraction, Presentation, manipulation, analysis, and reporting
• Integrated SAS datasets into Excel using Direct Data Exchange, using SAS to analyze data, statistical tables, listings and graphs for reports
• Participated in study locks by doing teh final analysis of teh data and reports. Followed validation process for all teh IT systems created. Prepared Data Definitions for teh studies
• Formatted HTML and RTF reports, using SAS - output delivery system ODS
• Documented and designed SAS code and Reports
• Pulled out data from teh Oracle clinical database and prepare customized analysis datasets for specific reporting needs
• Transferred and migrated data from one platform to another to be used for further analysis. Extracted data from SQL pass through facility or LIBNAME method and generated ad-hoc reports
• Access to relational databases using DB2 server..
• Experience in troubleshooting and analytical skills.

Environment: BASE/SAS, SAS/ MACRO, SAS/ SQL, and SAS/ACCESS, EBI, SAS enterprise guide,ORACLE and MS SQL Server, R language

Confidential, Tampa, Fl

SAS Data Programmer

Responsibilities:

• Interface with teh Business Users, Research and Analysis team as well as marketing representatives to validate business requirements/requests for analysis and present intermediate and final analytical results
• Worked extensively in sorting, merging, concatenating and modifying SAS Data sets.
• Analyzed data using various statistical procedures like PROC SUMMARY, PROC MEANS, PROC FREQ, PROC REG, and PROC ANOVA.
• Used BASE SAS, SAS Enterprise Guide, Macros, and SAS SQL for programming.
• Worked on extending SAS Enterprise Guide capabilities by developing customized add in programs.
• Programmed with SAS Enterprise Guide query builder for constructing complex queries analysis
• Executed Process Flows using SAS Enterprise Guide to obtain teh desired results
• Store and distribute SAS Enterprise Guide results in different formats (HTML, PDF, RTF) based on different user groups.
• Documented methodology, data reports, and model results, and communicated with project team/manager to share knowledge.
• Worked with large data sets and transactional data.
• Monitoring and managing teh data feeds into teh data warehouse as well as extraction transformation and loading.
• Created new datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, and conditional statements.
• Modified macros for report generation using SAS Macros as per teh requirements.
• Created a scorecard style model (binned variables with regression coefficients), some exploratory data analysis reports, and scoring code written in SQL.
• Performed sales forecasting, segmentation, testing, consumer profiling, Market mix modeling.
• Extensively used Data Null and SAS procedures such as Print, 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 e.g., SAS Integration Studio, SAS Enterprise Guide, SAS/Graph, SAS/SQL, SAS/Connect and SAS/Access.

Environment: Base SAS, Enterprise Guide

Confidential

SAS Clinical Programmer

Responsibilities:

• Successfully implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed Phase I to Phase IV Clinical Trials data.
• Proficient in drawing flowcharts indicating teh input data sets, sorting and merging techniques to get therequired report.
• Developed and maintained programs in SAS using SAS tools for Windows and Unix in a user supportenvironment.
• Extensive experience with teh SAS programming and in data step and with various SAS Procedures inBase SAS and SAS/Stat, including thorough knowledge of SAS Macro Language.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools -SAS/Base, SAS/Macros and SAS/Graph, SAS/SQL.
• Involved in preparation and interpretation of Table Programming for Integrated Summaries of Efficacy(ISE) and Safety (ISS), IND and NDA application for FDA submission.
• Generated tables, reports, listings and graphs for Clinical Study Reports in compliance with 21 Code ofFederal Regulations (21 CFR) Part 11, FDA, ICH, and GCP guidelines.
• Program documentation on all programs, files and variables for accurate historical record and for futurereference.
• Convert MS-Word documents, MS-Excel, sql tables into data sets.
• Extensively used SAS/ Macro facility to provide reusable programs dat can be conveniently used time totime.
• Explained teh purpose and functions of complicated SAS programs to non-statistical personnel, and wasresponsible for ensuring teh validity and accuracy of data analysis.
• Conducted statistical modeling for both continuous and categorical data, including linear regression,nonlinear regression, ANOVA, GLM model, repeated measure.
• Produced quality customized reports by using PROC TABULATE, REPORT, SUMMARY and alsoprovided descriptive statistics using PROC Means, Frequency, Univariate.
• Involved in writing of clinical trial reports (phase 4), analyzing, and presenting trial results.
• Formatted HTML and RTF reports, using SAS - output delivery system ODS

Environment: SAS/Base 9.0, SAS/Macros, SAS/Stat, SAS/Graph, SAS/ODS, SAS/SQL, SAS/Connect, SAS/Access, MS-Excel, MS-PowerPoint, UNIX and Windows NT.

Confidential

SASProgrammer

Responsibilities:

• Worked in Phase I & II ofclinicaltrials for studies in teh Cardio-Vascular therapeutic area.
• Integrate Data from wide range of sources including in-houseclinicaldata management systems, labs and contract research organizations and perform data cleaning with data steps using DLM, DSM, and COMMA9. TRUNCOVER, MISSOVER etc.
• Performed data validation on teh data sets and deleted repeated values using conditional data steps such as @@, if-tan statements.
• Designed statistical tables, graphs, and data listings.
• DevelopedSASmacros for data cleaning and reporting and to support routing processing.
• Performed Data Analysis on teh data sets using PROC ANNOVA, PROC MEAN, PROC UNIVARIATE,
• Developed reports using PROC REPORT, PROC TABULATE and DATA NULL .
• Generated output files in text format, HTML & PDF format usingSASODS.

Environment:SASBASE,SAS/STAT, SAS/SQL,SASMacro,SAS/ACCESS, and UNIX