PROFESSIONAL SUMMARY:

• Base SAS Programmer with Eight Plus yearsofSASprogramming experience inStatistical analysis, Validation and Statistical report generation of HealthcareandClinical trial data.
• Extensive experience in the application of SAS tools such as SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/MACROS, SAS/SQL, SAS/ENTERPRISE GUIDE and SAS/ODS.
• Extensive experience in creating external files and customized reports using SAS procedures such as Proc Report, Proc Tabulate, Proc Means, Proc Freq, Proc Univariate, Data Null, Proc Summary.
• Experience in validating Tables, listings and CRTs manually and using Proc Compare as well as with departmental standard macros.
• Solid knowledge of ADS creation, CRT dataset creation, CDISC and MedDra for regulatory submissions.
• Extensive knowledge of CDISC, SDTM and ADAM models.
• Strong understanding of Clinical Trials (Phases I - IV), FDA guidelines, and GXPs (Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice).
• Solid knowledge in clinical trial data like Demographic data, Adverse Events data, Subject listings, Concomitant medications, Vital Signs data, Laboratory data etc.
• Proficiency in writing maintainable, supportable, and well-documented SAS codes.
• Experienced in Data management, data extraction, manipulation, validation, purification and analyzing large sized data.
• Experience in generating RTF, HTML and PDF formatted files using SAS/ODS.
• Experience in developing SAS Macros, applications for data cleaning and reporting and involved in preparing documentation.
• Worked on statistical parametric analysis methods such as Correlation, Regression, Analysis of variance and general linear models using SAS STAT procedures such as PROC ANOVA, PROC GLM, PROC CORR, PROC REG.
• Maintained and enhanced existing SAS REPORTING PROGRAMS for FDA Submissions.
• Good understanding of study related STATISTICAL ANALYSIS PLAN (SAP) and produced Tables, Listings and Graphs based on the specifications in SAP.

TECHNICAL SKILLS:

SAS Skills: SAS v9, v9.1, v9.2 SAS/BASE, SAS/MACRO, SAS/SQL, SAS/ STAT

Office Tools: MS Office, Excel, Power Point and Word.

Operating Systems: Windows and UNIX

Databases: Oracle Clinical, SQL Server.

Languages: C, SAS, and SQL

PROFESSIONAL EXPERIENCE:

Confidential, Waukesha, WI

Statistical Programmer

Responsibilities:

• Developed SAS programs with the use of Base SAS and SAS/Macros for ad hoc jobs.
• Modified the existing programs according to the new business rules.
• Extensively used SAS procedures like Print, Sort, SQL, Means, Summary, Freq etc.
• Ran the monthly and quarterly maintenance jobs on the mainframe.
• Documented the run instructions for two different processes in a project.
• Prepared new Datasets and modified existing datasets using Set, Merge, Sort, Update, Formats and Functions and created Tables and Listings for the same.
• Participated in designing, coding, testing, debugging and documenting SAS Programs
• Statistical analysis included coding the data sets, calculating simple percentage distributions, graphs, comparison of rates by Agency’s t-test and chi-square test, multiple tables and reports developed using SAS/STAT
• Tuned complex Teradata queries to meet performance level agreements using Statistics, Indices, and Partitioning Techniques.
• Created RTF, PDF, HTML, LISTING, etc using Output Delivery System (ODS)
• Extensively used various SAS Data Step functions, SAS procedures, and SQL to write reports logics for SAS Stored Processes
• Converting existing Cognos reports to SAS web reports by creating SAS Information Maps and using those maps for creating SAS web reports using SAS Web Report Studio.
• Created SAS Customized Reports using the Data Null technique for FDA evaluations.
• Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provided descriptive statistics using PROC Means, Frequency, and Univariate.
• Created survival graphs in MS-Excel by transporting SAS data sets into Excel spreadsheets.
• Formatted HTML and RTF reports, using SAS - output delivery system ODS.
• Used the SAS Macro facility to produce weekly and monthly reports.
• Developed new reporting and maintained existing reporting related to billing operations in Business intelligence.
• Developed Flat files from Teradata using fast export, Bteq to disseminate to downstream dependent systems.
• Validated programs and databases.
• Created SAS programs usingProc Report, Proc Summaryto generate reports on patients who deviate from protocol specifications.

Environment: Base SAS, SAS MACRO, SAS/SQL, SAS/STAT, SAS/GRAPH, Teradata V2R6/12 and Windows 2000

Confidential, San Francisco, CA

Statistical Programmer

Responsibilities:

• Responsible for providing SAS programming and analysis support for phase III clinical study.
• Extracted raw data from excel and created SAS data sets that were required for the project analysis.
• Modified existing SAS programs and created new programs using SAS macro variables to improve ease and speed of modification as well as to obtain consistency in results.
• Generate Tables, listings and graphs, including Patient Demography and Characteristics, Adverse Events, Laboratory etc.
• Designed dashboard with website’s key events and goals for each departments, and schedule the email report distribution, and custom alerts for monitoring purposes on Business Intelligence.
• Reviewed data from clinical trials and developed plans to presenting results to FDA.
• Based on the mapping specification document created CDISC-SDTM SAS datasets which were compliant to all CDISC standards.
• Validated SDTM SAS datasets using SAS QC Macros, finally converting them into Transport files.
• Loading Data to the Teradata Data Warehouse Tables from multiple data sources using Teradata utilities Fastload, Mload, TPT, BTEQ, and Tpump.
• Reviewed protocol and Case Report Forms to identify irregular data entry errors of clinical trial data. Created safety and efficacy customized reports for FDA regulatory submissions.
• Involved in writing SDTM QC Macros that validates the SDTM datasets against FDA guidelines.
• Involved in creating transport files for electronic submissions to the FDA.
• Created and validated various specifications for SDTM and ADAM transfer purposes.

Environment: SAS V9.1, SAS BASE, SAS MACRO, SAS/STAT, SAS/GRAPH, SAS/ODS, Windows XP/7

Confidential, Madison, WI

SAS programmer

Responsibilities:

• Developed SAS programs using SAS/BASE, SAS/SQL, SAS/STAT and SAS/MACROS for statistical analysis and data display.
• Performed data analysis on the data sets using PROC MEANS, PROC FREQ etc.
• Performed Quality control on SAS programs to ensure data flow in continuous for new data obtained
• Imported workable data into SAS from various data types and formats like metadata, MS Excel and MS Access files, delimited text files, and comma separated values (CSV) files.
• Extensively created summary reports using SAS PROCEDURES like PROC FREQ, PROC UNIVARIATE, PROC SUMMARY, PROC REPORT, PROC MEANS, and PROC TABULATE etc.
• Designed and built the Investor month-to-date Dashboard on the BI system to provide the status of investor performance in real time.
• Writing report to the management explaining above factors and help them making better business priority such as picking the best management/properties to start business negotiations using BI
• Present results in the form of spreadsheets, tabulate, graphics and reports using SAS.
• Manipulated and managed data extracted from flat files in SAS
• Work on Teradata Store procedures for batch deletes.
• Created large datasets by combining individual datasets using various inner and outer joins in SAS/SQL and dataset merging techniques of SAS/BASE
• Performed statistical analyses on various source SAS datasets
• Documented purpose and methods used in each SAS program.
• Used ODS statements and PROC TEMPLATE to create reports in style format.
• Used SAS extensively to create ad hoc reports.
• Used SAS Macros, PROC SQL to extract, sort; match test accounts and ODS to HTML, PDF and RTF.

Environment: SAS V9.1, SAS BASE, SAS MACRO, SAS/STAT, SAS/GRAPH, SAS/ODS, Windows XP/7

Confidential, Exton, PA

SAS Programmer

Responsibilities:

• Wrote edit check programs to ensure data quality
• Performed Data Extraction to generate Ad-Hoc TLs
• Performed output review to validate reports
• Generated safety tables, reports and listings related to demographics, adverse events, lab, study completion and study discontinuation
• Thorough knowledge of Drug Development Process and Clinical Trials
• Performed data analysis, statistical analysis, generated reports, listings using SAS Tools, SAS/MACROS
• Performed sorting and merging techniques on the input data sets for Data Preparation.
• Extensively used SAS/Macro to provide reusable programs that can be conveniently used from time to time
• Performed incorporating SAS Business Intelligence (BI) Platform into organization's reporting function. Developed proof-of-concept reporting and operations manual.
• Produced quality customized reports by using Proc Tabulate, Proc Report, Proc Summary and also provided descriptive statistics using Proc Means, Proc Frequency and Proc Univariate
• Created Statistical tables and listings specifications
• Performing in-depth quantitative analysis and data analysis
• Extensively used procedures like Proc SQL, Proc Print and Proc sort
• Coding SAS programs with the use of SAS/BASE and SAS/MACROS
• Analyzed Specification and production and reporting deliverables
• Performed program documentation on all programs, files and variables for accurate historical record and for future reference by using CDISC
• Designed SAS programs to access, validate and summarize data, including validation of derived variables

Environment: SAS/BASE 9.1, SAS MACROS, Windows XP, SAS/Reports, SAS/STAT, SAS/SQL, SAS/ODS

Confidential

SAS Programmer

Responsibilities:

• Supporting safety and efficacy analysis by generating tables, listings and figures using SAS/Base, SAS/Macros, SAS/STAT and SAS/SQL.
• Writing queries using PL/SQL to transfer data from multiple data sources.
• Supporting the creation of safety and efficacy tables, listing and figures for CSR.
• Developed new reporting and maintained existing reporting related to billing operations in Business intelligence.
• Developed study specific and standard macros using SAS/Macro to compute derive variables by following the rules defined in protocol and SAP.
• Understands the business issues and data challenges of business partner's organization and industry
• Performing QC Tasks to validate and verify outputs in form of (tables, listings, analysis datasets etc.)
• Produced quality customized reports by using PROC TABULATE and SUMMARY and also provided descriptive statistics using PROC MEANS and PROC PRINT.
• Interacting with Statisticians on regular basis to clarify the analysis definition rules.

Environment: SAS/BASE, PL/SQL, SAS/MACRO, SAS/SQL, SAS/STAT, MS Office Package, Windows 2000/XP