SUMMARY:

• Experienced SAS Programmer with over 7 years of experience in working with SAS and SAS tools emphasizing on analysis, design, developing, testing and implementation of various projects for pharmaceutical and biotech industries on Windows and Unix environment.
• Good Knowledge in Clinical SAS Programming using SAS 9.2 in Pharmaceutical industry.
• Extensive experience in BASE SAS, SAS/GRAPH, SAS/SQL, SAS/MACROS, SAS/ODS.
• Experienced in Base SAS procedures such as Proc Freq, Means, Summary, Univariate, Format, Import, Export, Report, Tabulate, Transpose, Datasets, Copy and Print.
• Skilled in SAS programming, merging SAS datasets, preparing data, producing and validating reports, SAS formats, and managing data.
• Experience in using SAS to read, write, import and export to another data file formats, including delimited files, Spread sheet, Microsoft Excel and Access tables.
• Expert in using the ODS facility to create HTML, RTF, XML and PDF files.
• Hands on experience in Phase I, II, and III clinical data: analysing clinical data, creating tables, listing and generating reports and graphs.
• Worked with statisticians and clinical data managers to provide SAS programming in analysing the data, generated reports, tables, listings and graphs.
• Good working knowledge of clinical trials data like Demographic, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory Data (LAB Data).
• Familiar with ICH, GCP, FDA guidelines and Knowledge of industry practices with CDISC standards, electronic submissions standards and Models including SDTM, ADaM data models.
• Developed tables, graphs and listings for Clinical Study Reports by conducting, documenting and reporting in compliance with 21 Code of Federal Regulations (21CFR) Part 11, FDA and other regulatory compliances.
• Strong working knowledge of FDA regulations, ICH Guidelines and GCP requirements.
• Exceptional problem solving skills for delivering useful and prudent solutions.
• A quick learner with an eye for detail and excellent analytical and quantitative skills.
• Excellent written and communication skills, self-starter and a good team player.
• Knowledge inICH- GCP & IRB
• Knowledge in Ethical Regulations and Federal regulations.
• Review the respective study protocol/CRF.Setup of Databases.
• Good knowledge in Oracle Clinica and Informa tool.
• Preparation and validation of data validation & STDM mapping programs.
• Prepare and review Data Transfer Agreements.
• Reconciliation of external data.

TECHNICAL SKILLS:

SAS Tools : SAS V9.1.3, Base SAS, SAS/SQL, SAS/MACROS, SAS/STAT,
SAS/GRAPH, SAS/ODS, SAS/BASE, SAS/ACCESS
Operating Systems : Windows 2003 Server, Windows NT/2000/XP, UNIX.
Databases : Oracle, MS SQL SERVER & MS ACCESS.
SAS Skills : SAS (BASE, MACROS, CONNECT, GRAPH, SQL, ODS)
SAS Procedures : SORT, CONTENTS, TRANSPOSE, GPLOT, GCHART, FREQ, MEANS, SQL,
REPORT, TABULATE, PRINT, SUMMARY, CORR, UNIVARIATE
Database : MS Access, Oracle PL/SQL, SAS/SQL.
Operating Systems : Windows, UNIX Environments

PROFESSIONAL EXPERIENCE:

Confidential, Dallas, TX Aug2010 – Present
Sr. SAS Programmer
Description:

Responsibilities:

• Analysed the Clinical data for Phase II and Phase III studies.
• Generated Tables, Listings and Graphs using various procedures like Proc Freq, Proc Report, Proc Tabulate, Proc Univariate, Data _null, and Proc Gplot.
• Experienced in validating programs and in writing competing codes to re-check the statistical values of tables.
• Developed routine SAS macros to create tables, and listings for inclusion in Clinical study reports and regulatory submissions.
• Successfully designed and implemented statistical reporting processes.
• Performed Data Validation and Data cleaning by Peer-Reviewing.
• Performed Program Documentation on all programs, files and variables for accurate historical record and for future reference.
• Produced Tables, Listings and Graphs for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Created SAS Macros and SAS Graphs. Used Proc REPORT to generate reports.
• Review the Protocol, Case Report Forms (CRFs), and Statistical Analysis Plan (SAP) and Develop programs to create TLG's as per the SAP shell.
• Perform Validation on Derived datasets, Tables and Listings following the SOPs and document the same.
• Create Transport files using PROC COPY, CPORT etc and create the Define .pdf files for CRT's.
• Created derived dataset's Specification files for safety and efficacy data.
• Create Ad-hoc reports as per client requirements.
• Create and modify existing macros to meet the client needs.
• Database Creation and Table Programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Performing statistical analyses using various SAS/STAT procedures (MIXED, GLM, ANOVA, REG, CORR, FREQ, UNIVARIATE, MEANS etc) according to SAP and requirement of studies.
• Generated reports through ODS either in HTML, PDF or RTF formats according to the client specifications and good knowledge of CDISC standards.
• Created CDISC SDTM domain data sets from existing clinical trial data to provide Case Report Tabulation (CRT) data to a regulatory agency, such as the FDA and ADaM for describing the full protocol of a clinical trial
• Extensive use of PROC SQL to perform queries and join tables.

Environment: SAS/Base, SAS/STAT, SAS/GRAPH, SAS/Access, PL/SQL, Oracle 8, Clin trial, Excel, WinNT, Sun Solaris

Confidential, Baltimore, MD Feb2008 - Aug2010
Clinical SAS Programmer

Responsibilities:

• Produced data listings, summary tables and graphics for interim and final analysis and publications.
• Provided data in SAS transport files, and other appropriate deliverables and documentation for regulatory submissions.
• Participated in maintenance of software applications. Identifying enhancements and new features. Participated in requirement reviews. Took raw data and creating data sets for all programmers.
• Performed validation programming on clinical trial data using SAS MACROS.
• Created base macros to run reports. Creating standard reports to use across studies and creating base programs to set up data.
• Performed Data entry and conversions, data validation and corrections, uploading/ downloading data from/to a PC.
• Extensive use of PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC TRANSPOSE, PROC MIXED, PROC REPORT, PROC TABULATE, Data _Null_, and Chart procedures Ascertaining quality and standards for the code changes made.
• Tested and debugged against the test data.
• Developed programs for creating new variables and Transforming horizontal CRF data into Vertical dataset according to CDISC guidelines.
• Used SAS for pre-processing data, data analysis, generating reports, statistical analysis, and graphs.
• Responsible for locating appropriate databases for projects.
• Responsible for implementing and monitoring clinical research trials, tracking study progress, and ensuring data integrity.

Environment: SAS 9.1, SAS/BASE, SAS/MACROS, MS ACCESS 98/2000, Windows NT, UNIX.

Confidential, PA July2006 – Jan 2008
Clinical SAS Programmer

Responsibilities:

• Converted the clinical trial data, subject records entered in the database files to SAS data sets using SAS/Access.
• Optimized performance using Data Validation and Data Cleaning on Clinical Trial Data.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs usingSAS Tools – SAS/Base, SAS/Macros and SAS/SQL.
• Created SAS datasets from Microsoft Excel files using Proc Import and Import Wizard.
• Generated Tables, Listings and Graphs using various procedures like PROC FREQ, Proc Report, Proc Tabulate PROC UNIVARIATE, Data _null_, Proc Plot, and Proc Gplot SUMMARY and also provided descriptive statistics using PROC Means,
• Retrieved tables from Oracle Clinical databases with PROC SQL using
• 'Pass through Facility'.
• Created CRT (Case Report Tabulations) datasets using CDISC standards for submissions to the FDA.
• Extensively used Dynamic Data Exchange (DDE) for importing data in Excel sheets into SAS.
• Produced RTF, MSWORD and HTML formatted files using SAS/ODS to
• Produce ADHOC reports for presentation and further analysis.
• Performed quality controls (QC) on SAS programs.
• Documented all project data flows and programs.

Environment: SAS/Base, SAS/STAT, SAS/GRAPH, SAS/Access, PL/SQL, Oracle 8, Excel, WinNT, Sun Solaris.

Confidential, Connecticut June2005 – June2006
Clinical SAS Programmer

• Created new analysis datasets from raw datasets for clinical trials.
• Extensively involved in creating safety and efficacy tables, listing and figures.
• Performed Quality Checks on the existing table, listing and figures.
• Extensively used company standard macros for effective and efficient outputs for clinical trials. Created study specific macros for better performance.
• Developed programs for creating new variables and Transforming horizontal CRF data into Vertical dataset according to CDISC guidelines.
• Generated reports using Proc Tabulate, Proc Report, Data Null, SAS arrays, Proc SQL, and SAS Macros.
• Participated in Weekly Meeting with Team Lead, Co-workers to discuss about the work progress and queries regarding Project.

Environment: SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/SQL, SAS/WINDOWS.