SUMMARY

• 7 years of experience as SAS programmer with strong emphasis in data analysis, Clinical trials and Health Care data.
• Experience in Base SAS, SAS/Macros, SAS/SQL, SAS/Assist, SAS/Connect, SAS/STAT, SAS/Access, SAS/GRAPH, SAS/ETS, SAS ETL and SAS/ODS.
• Strong expertise in design, development, analysis, testing and implementation of various SAS applications with in Clinical and Health care domains.
• Posses excellent skills with PROC SQL, SAS DDE, SAS Arrays, SAS Base procedures, summary procedures and especially Data Step programming and reporting.
• Good at creating, reviewing, retrieving, validating Datasets and to read, write, import and export to another data file formats.
• Extraction and creation of data tables using SAS/Access, SAS/SQL from large scale databases.
• Worked extensively on various SDTM domains such as Interventions - Exposure (EX), Comments (CM), Substance use (SU), Events - Adverse Events (AE), Medical History (MH), Disposition (DS), Clinical Events (CE), Protocol Deviation (DV), Findings - (EG), LB, IE, Vital signs (VS), Physical Examination (PE), Subject Characteristics (SC), PC, PP, Drug Accountability (DA).
• Worked on Special Purpose Domains like Demographics (DM), Subject Elements (SE), Subject Visits (SV), Comments (CO) & their SUPPQUAL datasets.
• Created summarize safety and efficacy (ISS/ISE) tables for FDA submission.
• Preparing FDA E-submission ready reporting documentation including creating DDT’s, Transport files (XPORT format files).
• 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.
• Experienced in data management and reporting.
• Experience in producing external files and reports employing various SAS statements and procedures, such as null, ODS, Proc Print, Proc Report, Proc Tabulate in Clinical Trials.
• Ability to work well within a team and with all levels of professionals.
• Experience on SDTM Annotated CRF and Define.xml.
• Experience in implementing CDISC SDTM for intervention, event and findings domain models and ADaM standards, knowledge of SDTM terminologies.

TECHNICAL SKILLS

SAS Tools: SAS V9.1.3, SAS V9.2, SAS V8.1 Base SAS, SAS/SQL, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/ACCESS

Operating Systems: Windows 2003 Server, Windows NT/2000/XP, UNIX, Solaris

Databases: Oracle, MS SQL SERVER & MS ACCESS

Internet Technologies: HTML, XML

Microsoft tools: MS office toolset(Word, Excel, Power point, Access)

Core Competencies: Statistical Programming, Clinical Trials, Data Analysis, Reports Development.

Other: Lotus notes, ORIGIN Software

PROFESSIONAL EXPERIENCE

Confidential, Canton, Michigan

Clinical SAS Programmer

Responsibilities:

• Analyzed the Phase I, II, and III clinical trials data.
• Created and performed QC check for SDTM annotations.
• Created analysis data sets and performed statistical analysis on raw data to achieve safety and efficacy objectives of the study using SAS procedures.
• Generated, modified and used departmental Macros as per requirement.
• Produced Tables, Listings and Graphs for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Performed validation on Tables, Listings, and Analysis Datasets through double programming using SAS Procedures like Proc Compare.
• Used SAS ODS to create HTML, RTF and PDF outputs files in the process of producing reports.
• Involved in validating data domains for SDTM which complies with CDISC SDTM standards.
• Developed programs to create SDTM domains, reviewed programs for quality check and used Proc Compare for QC check of the SDTM domains.
• The programming, testing, and documentation of statistical programs for use in creating statistical tables and listing summaries.
• The programming of analysis databases (derived datasets) and transfers of data for internal and external clients and the programming of database quality control checks.
• Generate the required SAS datasets from large database using Sorting and Merging techniques.
• Proc SQL, Proc Import, Proc Export was used to retrieve data from Excel.

Environment: SAS 9.2, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, Windows NT/ 2000, UNIX.

Confidential, New Jersey

SAS Programmer

Responsibilities:

• Analyzed the Phase I II, III clinical trials data.
• Created analysis data sets and performed statistical analysis on raw data to achieve safety and efficacy objectives of the study using SAS procedures.
• Generated, modified and used departmental Macros as per requirement.
• Produced Tables, Listings and Graphs for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Performed validation on Tables, Listings, and Analysis Datasets through double programming using SAS Procedures like Proc Compare.
• Used SAS ODS to create HTML, RTF and PDF outputs files in the process of producing reports.
• Involved in validating data domains for SDTM which complies with CDISC SDTM standards.
• Developed programs to create SDTM domains, reviewed programs for quality check and used Proc Compare for QC check of the SDTM domains.
• The programming, testing, and documentation of statistical programs for use in creating statistical tables and listing summaries.
• The programming of analysis databases (derived datasets) and transfers of data for internal and external clients and the programming of database quality control checks.
• Performed survival analysis by using Proc Lifetest, generated Kaplan- Meier plots.
• Develop and plan programming documentation including plans and specifications, as appropriate.
• Perform and plan the development, implementation and validation of new process technologies, macros and applications.
• Received different SAS transport files from Data managers. Used SAS program to convert SAS transport file to current platform.
• Generate the required SAS datasets from large database using Sorting and Merging techniques.
• 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.

Environment: SAS 9.2, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, Oracle8, Windows NT/ 2000.

Confidential, North Carolina

SAS Programmer

Responsibilities:

• Developed and maintained existing SAS programs that were used for creating various reports, lists, etc. for regulatory submissions.
• Created analysis data sets and performed statistical analysis on raw data to achieve safety and efficacy objectives of the study using SAS procedures.
• Generated Tables and Listings using various procedures like Proc Freq, Proc Univariate, Proc Means, Proc Summary, and Proc Report as per table shell.
• Applied different SAS procedures and macros for data cleaning, conversion and integration.
• Generated, modified and used departmental Macros as per requirement.
• Produced Tables, Listings and Graphs for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Performed validation on Tables, Listings, and Analysis Datasets through double programming using SAS Procedures like Proc Compare.
• Generated statistical significance values using various statistical procedures like Proc GLM, Proc Phreg.
• The programming, testing, and documentation of statistical programs for use in creating statistical tables and listing summaries.
• The programming of analysis databases (derived datasets) and transfers of data for internal and external clients and the programming of database quality control checks.
• Program the integration of databases from multiple studies or sources.
• Develop and plan programming documentation including plans and specifications, as appropriate.
• Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and the Statistical Programming department.
• Perform and plan the development, implementation and validation of new process technologies, macros and applications.
• Received different SAS transport files from Data managers. Used SAS program to convert SAS transport file to current platform.
• 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.
• Used FILENAME fileref in a SAS procedure to output analysis (Number of records, Patients, Visits, etc.) of text file to another file.
• 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.

Environment: SAS 9.1.3, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, Oracle8, Windows NT/ 2000.

Confidential, South Carolina

Statistical Analyst

Responsibilities:

• Created intricate set of SQL tables to hold user login and user access information with constraints and access errors were logged in to error tables.
• Acquired financial raw data from Oracle, Teradata and DB2 tables and loaded the data into SAS datasets Used Macro routines to convert different types of source file (Excel, Word, and Text) to produce SAS reports and graphs. Used Proc Dbload, Proc SQL, Proc import, Proc export statements to load SAS data sets from and to DB2 and Oracle 9i.
• Provide statistical programming expertise in the production of datasets, analyses, tabulations, graphics, and listings from client’s data.
• Create Information MAPS using the Information Map Studio for Analytics and Business Forecasting Team for creating the Time Series Forecasting Models and also written SAS Stored Processes to Create Efficient Reports and delivering it in the Web Portals using the Information Delivery Portal and SAS Management Console.
• Created edit check programs to find discrepancies in a raw dataset provided by Data Management Group.
• Developed and scheduled SAS jobs using Shell Scripts / UNIX - Crontab Jobs.
• Used SAS Access to ORACLE feature for large data extractions (SQL-Pass thru), PROC DBLOAD.
• Involved in various phases for segmentation and response analysis used for direct marketing campaigns.
• Forecasted impact of direct market campaigns for acquiring, developing and retaining customers using SAS.
• Developed and maintained SAS Web Reports for sales data based on the requirement.
• Implemented data management plans designed to meet project deadlines.

Environment: SAS 9.1 (SAS/Access, SAS/Connect, SAS/Stat, SAS/Graph, SAS/SQL, SAS/ODS), Oracle 9i, Teradata, DB2, MS Excel, Solaris 8, K-Shell.

Confidential

SAS Programmer

Responsibilities:

• Performed various data management activities like pre-processing of data, writing SQL queries, edit check programming, and statistical analysis using Base SAS and various other tools -SAS/SQL, SAS/MACRO, SAS/STAT, SAS/CONNECT, and SAS/ACCESS.
• Developed SAS programs for extracting the Oracle Database into SAS datasets using SQL Pass through facility.
• Used Proc Import and Import Wizard to generate datasets from Excel sheets.
• Conducted analysis on the raw data to achieve the safety and efficacy objectives of the study using various SAS procedures such as FREQ, MEANS, UNIVARIATE, TTEST, CORR, REG etc.
• Developed and validated SAS programs following the information stated in Statistical Analysis Plan (SAP).
• Safety tables included Adverse Events (AE), Vital Signs, Laboratory Values, and Concomitant Medications etc.
• Involved in validating SAS programs developed by other programmers for the efficacy and safety tables.
• Created Tables and Listing for Safety as well as Efficacy analysis for the Study.
• Involved in generating the summary tables required in submission of ISS and ISE as per FDA regulation.
• Generated reports using PROC FREQ, MEANS, PRINT, TABLUATE and REPORT.
• Implemented edit checks utilizing SAS MACROS.
• Created CRT (Case Report Tabulation) for both standard and new domains.
• Contributed to the development of standard operating procedures (SOPs).
• Produced ad-hoc reports as per requests.

Environment: SAS/GRAPH, SAS/CONNECT, SAS/GRAPH, SAS/STAT, Excel, Access, DB2, Oracle 8i.

Confidential

SAS programmer

Responsibilities:

• As a SAS Programmer provided programming support for the data management and reporting of Clinical Trials data.
• Acted as liaison between programming team and data management team to understand analysis data definitions, summary table and listing specifications as related to SAS programming tasks.
• Worked closely with Clinical Data Management to support data integrity checks and adherence to data definition standards.
• Extracted data from various data sources and performed quality checks to create Analysis data sets.
• Generated derived variables for the analysis datasets using various functions and procedures.
• Extensively performed sorting, indexing, merging on the clinical data and generated reports.
• Performed Data analysis and generated reports and listings using SAS procedures such as Proc Means, Proc Tabulate, Proc Freq, Proc Summary, and Proc Report.
• Developed and extensively used existing SAS macros for Validation, Analysis and Report generation.
• Created reports in various other formats like PDF, HTML, RTF using ODS statements and PROC Export.