SUMMARY

• Over 8 years of strong experience as SAS Programmer in Clinical research industry
• Experience inClinicalData Interchange Standards Consortium (CDISC) process related to data standards including Study Data Tabulation Model (SDTM) and Analysis Dataset Models (ADaM).
• Preparing SDTM datasets and analysis reports following the ADaM format for integrated summary of safety and effectiveness.
• Implementing CDISC standards to clinical trial data through converting raw datasets to SDTM datasets with reference of mapping documents prepared by following SDTMIG.
• Created several domains inCDISCi.e., both SDTM and ADAM datasets on production side as well as validation side using specification.
• Knowledge of CTMS, drug discovery and development, bioinformatics, ICH - GCP, drug protocol development, clinical trials,CDISC, SDTM, ADaM, clinical data management, CRF Design, EDC and Pharmacovigilance.
• Case report form annotation,SDTMstart and end date and dataset implementation.
• SDTMdata management and migration approval from review and metadata document review.
• Good experience in Clinical Trials, Clinical Data Analysis, Clinical Data Migration, generating Statistical Analysis files, Tables, Listings, Graphs, Validations, Documentation.
• Clinical trial data analysis, metadata document creation including trial arm, trial visit trial inclusion and exclusion, trial element and trial summary.
• Strong experience in Base SAS, SAS/MACROS, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STAT, and SAS/SQL in windows environment.
• Expertise in creation of user defined MACROS.
• Creation of new datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Update, and Conditional statements.
• Expert in using PROC SQL, DATA, MERGE, SORT to generate adhoc and customized reports
• Extensive programming experience with procedures like SQL, SORT, Regression, REPORT, FORMAT, FREQ, MEANS, TABULATE, TRANSPOSE etc.
• Experienced in generating reports (outputs) with report procedure and data null .
• Experienced in producing RTF, HTML and PDF formatted files using SAS/ODS.

TECHNICAL SKILLS

Statistical Software: SASV9.1.3, SAS 9.2, SAS 9.3 Base SAS, SAS/SQL, SAS/MACROS, SAS DM, SAS/STAT, SAS/GRAPH, SAS/ODSSAS/ACCESS, SAS/CONNECT

Reporting Tools: MS Excel, MS Word.

Databases: Oracle, MS-Access

Operating systems: Windows, UNIX.

PROFESSIONAL EXPERIENCE

Confidential, Lake Mary, Florida

Clinical SAS Programmer

Responsibilities:

• Understanding the study related documents such as Protocol and SAP.
• Generating the SDTM datasets from raw datasets as per CDISC SDTM 3.1.2.
• Worked with clinical research staff and study group to provide SAS programming support for Clinical Trial projects.
• Assisted with analysis planning including review of table and listing mock ups as well as dataset analysis as per requirements.
• Validated programming output with other programmers output and mock ups in Statistical Analysis Plan using PROC COMPARE.
• Used DATA step to derive analysis dataset from raw dataset using define feature in SAP and Clinical Report Forms (CRF’s).
• Used various procedures like PROC FREQ, PROC MEANS, PROC TABULATE, PROC SUMMARY and PROC REPORT to generate various data tables, patient data listings and reports according to Statistical Analysis Plan (SAP).
• Contributed to Integrated Summary of Safety (ISS) analysis.
• Created tables, graphs and listings (TGL’s) for inclusion in clinical study reports and regulatory submissions and also maintained existing ones by using SAS MACROS.
• Ensured that analysis data and programming codes met the regulatory and company standards and were consistently structured to permit efficient programming and reporting.
• Prepared detailed analysis plan from study protocols with other biostatisticians.
• Wrote Customized Safety and Efficacy Reports directing SAS output to RTF and HTML files using Output Delivery System (ODS) facility.

Environment: SAS/ODS, SAS/MACROS, Windows, UNIX, SQL Server, MS Access, SAS 9.3.

Confidential, Princeton, NJ

Clinical SAS Programmer/Analyst

Responsibilities:

• Conceptualized Clinical trials phase II and III through SAS programming by providing statistical support to Statisticians and Biostatisticians.
• Tables, Listings and Graphs were created successfully using Proc Report, Proc Tabulate, Data Null, Proc Plot and Proc GPlot.
• Existing datasets relating to multiple studies was modified using SAS Macros.
• Created CRT (Case Report Tabulations) datasets using ODM model of CDISC standards for FDA Submission.
• Developed Tables, Listings and Graphs from Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Processed Quality control by creating SAS codes using various statistical procedures such as Proc Freq, Proc Means, Proc Univariate, Proc Summary, Proc Transpose, Proc SQL and Proc Print.
• Successfully validated TLG’s and CRT’s through independent validation using Proc Compare and standard Macros.
• Maintained appropriate study application documentation.
• Program documentation on all programs, files and variables was performed for accurate historical record and also for future reference.
• Optimized performance of Clinical trial data using data cleaning and data validation.

Environment: SAS 9.2 Windows, SAS/BASE, SAS/MACROS SAS/ODS, SAS GRAPH, SAS STAT and MS-Excel.

Confidential, Raleigh, NC

Senior SAS Programmer/Analyst

Responsibilities:

• Responsible for Business analysis and requirements gathering of SAS reporting new and existing codes.
• Gathering requirements and documentation for unit test case development and defining and documenting the integration testing of new applications.
• Maintained performance reports, creation of reports for online and batch application of various servers and involved in preparing executive Dashboards for senior level management.
• Designedand developedtheexperimental setupwith a wind tunneland analyzedthe performance of vertical axiswind turbine.
• Simulatedwind turbineusingANSYSand validated with the experimental result
• Used SAS, SAS/Macros, Procedures like SQL, Freq, Summary, Means, Transpose, Arrays, Tabulate and Sort to extract data, Prepare integrated data base and its analysis.
• Construct campaigns using a combination of Unica campaign, SQL based on inputs from the campaign owners
• Extracted data sets from server using Proc Import and created datasets in SAS libraries, Coding SAS Programs with the use of SAS/Base and SAS/Macros for ad hoc jobs.
• Developed programs to created daily HTML reports using ODS and CSV reports using Proc Export.
• Worked with SQL, Macro and DI Studio ETL processes, extracted transformed and loaded data, mapped, scheduled and submitted job to Unix and Oracle environment.
• Created views on Oracle tables and indexes on SAS datasets to enhance the speed and performance of the SAS programs.
• Created shell scripts which would take arguments from the command line and create subdirectories to store the listing files, output files and graph files.
• Developed web-based reports, scorecards, and dashboards using SAS Information Delivery Portal, Web Report Studio, BI Dashboard, Stored Processes, and SAS Server pages.
• Create OLAP cubes using SAS OLAP tools for the creation of dashboards and drill-through web based reporting.
• Developed methods to streamline analysis and present business critical information through a combination of SAS BI dashboards and web-based reporting.
• Assist with the creation, support and scheduling of SAS programs within the reporting infrastructure.

Environment: SAS 9.1.3, SAS/BI, SAS/DI Studio, Olap cube, Information Map Studio, SAS/Base SAS/Macros, SAS/Access, SAS/Connect, SAS/SQL, SAS/Enterprise Guide, Oracle, DB2, Windows and Linux, Unix-AIX 6.1

Confidential, MN

Clinical SAS Programming Consultant

Responsibilities:

• Worked in Phases of clinical trials for heart diseases and diabetes.
• Designed and implemented statistical reporting processes for clinical data analysis.
• Extensively used SAS/Macro facility to provide reusable programs that can be conveniently used time to time and created tables, listing and graphical reports.
• Generated output files in text format, HTML & PDF format using SAS ODS.
• Created SAS transport (.xpt) files and converted the Transport files into SAS Data Sets.
• Used SAS/ACCESS to extract data from Oracle and other relational databases for analysis.
• Developed reports using PROC REPORT, PROC TABULATE and DATA NULL .
• Designed flow charts indicating the input datasets and the techniques that would be used (sort, merge, append) to get the desired output.
• Data Analysis and graphical presentation for various summary reports using Base SAS and SAS/Graph facility.
• Developed SAS programs for listing of tables for data review and presentation including adhoc reports, CRTs as per CDISC, patients listing mapping of safety database and safety tables.
• Created CRT (Case Report Tabulations) datasets using CDISC standards for submissions to the FDA.
• Performed data validation on the data sets and deleted repeated values using conditional data steps such as @@, if-then statements.
• Good working knowledge of Clinical Trials data like Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data (Lab data), Physical and Vital Signs and Audit trials.
• Established and maintained a sound working relationship and effective communication within (worked with) Bio-Statistics and Statistical Reporting and Clinical Research and Database personnel.

Environment: Windows, SAS 9.1, SAS/BASE, SAS/STAT, SAS/MACROS.

Confidential

Clinical SAS Programming Consultant

Responsibilities:

• Used SAS Base procedures like PROC FREQ and PROC UNIVARIATE to generate Safety tables (Adverse Events, Demographic listing) and quality tables for clinical study reports and regulatory submissions.
• Developed SAS macros for data cleaning and Reporting.
• Generated statistical analysis files, tables, listings, and graphs for clinical trial studies
• Involved in delivering output using SAS/ODS.
• Extracted data from databases and also flat files.
• Created html and PDF output files by using SAS ODS AND PROC REPORT, PROC TABULATE, DATA NULL AND PROC SQL to customize the reports
• Enhanced reports through the use of labels, SAS formats, user-defined formats, titles, footnotes and SAS system reporting options.
• Integrate Data from wide range of sources including in-house clinical data management systems, labs and contract research organizations and perform data cleaning with data steps using DLM, DSM, TRUNCOVER, MISSOVER etc.

Environment: SAS/ODS, SAS/SQL, SAS/REPORT, SAS/GRAPH, SAS/BASE, SAS/MACRO, MS EXCEL, MS ACCESS.