Summary:

• Professional experience of 5+ years working with SAS tools to provide solutions for pharmaceutical industries on clinical research trails (Phase I- IV).
• Working experience in different therapeutic areas (Diabetic study, Leukemia, Pain and Neurology).
• Good working knowledge on safety and efficacy data as well as SDTM and ADAM models.
• Worked with statisticians to analyze clinical data and generated TLG’s as per the requirements.
• Familiar with Code of Federal Regulations (21 CFR Part11).
• Familiar with ICH guidelines, CDISC standards and electronic submission standards for FDA.
• Experience in adherence of SAS programs to Standard Operating Procedures (SOP) and Statistical Analysis Plan (SAP).
• Experience in writing macros and modifying company macros as per the specifications.
• Have worked closely with statisticians/data managers in analyzing the clinical trial data and generating the Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) tables, listings and graphs.
• Generated tables and listings for Adhoc requests.
• Generated output files in PDF, RTF and HTML format using SAS ODS.
• Strong working knowledge of Base SAS, SAS Macros, SAS/ACCESS, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/SQL in Windows and UNIX environments.
• Experience in producing customized reports using Proc Report.
• Experience in data validation, data manipulation, data processing and data cleaning.
• Expert in using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Highly motivated and quick learner with willingness to assume responsibility.
• Excellent communication skills, analytical, interpersonal, presentation, problem solving skills and ability to work in a team or independently.

Technical Skills:

• Operating systems: Windows, UNIX
• Office Tools: MS Word, Excel and Power Point.
• Databases: Oracle, SQL Server and MS-Access.
• SAS Procedures: Report, Univariate, Correlation, Regression, Anova, Gplot, Lifetest, Format, Freq, Compare, Contents, summary, Transpose, Import and Export.
• SAS Tools: SAS 9.0/8.0 (SAS/ Base, SAS/Macros, SAS/Graph, SAS/SQL, SAS/ access, SAS/Stat, SAS/ODS, SAS/Connect.

Education:

• Bachelor’s in Computer Science.

Professional Experience:

Confidential, Dallas, TX (Jan 2011 - Present)
Clinical SAS Programmer

Role & Responsibilities:

• Generated statistical analysis files, tables, listings and graphs on Phase I-IVof clinical trials in therapeutic areas like Diabetic study, Leukemia, Pain and Neurology.
• Extracted the raw data from Oriclinical database using SQL queries and created SAS datasets required for project.
• Generated analysis datasets as per ADAM standards and created Tables, Listings and Graphs for the assigned project.
• Well knowledge on SDTM and ADAM models.
• Performed data cleaning using edit check programs for removing invalid data from the database.
• Created safety analysis datasets related to Demographics, Concomitant medication, Lab, Vital signs, Medical history and Adverse events.
• Working experience with Pharmacokinetics Data.
• Well knowledge in using statistical procedures like Proc Summary, Proc Freq, Proc GLM, Proc Logistics, Proc Mixed and Proc Corr.
• SAS/GRAPH procedures like Proc Gplot and Proc Lifetest used for generating reports as per the project requirement.
• Validated tables, listings, graphs and datasets using double programming and QC check.
• Extracted data from flat files (text files and excel spread sheets).
• Created PDF, RTF and HTML reports by using SAS ODS system.
• Created Scatter plots, Kaplan-Meier plots and line charts.
• Used company macros for generating customized graphs and reports.
• Generated Descriptive Statistics (N, Mean, Median, Range, Mode, Stddev, Min and Max) and Inferential Statistics (P-value, LS Means).
• Generated ISS/ISE Tables and listings.
• Created the datasets and developed reports as per the statistician requirements.
• Produced tables, listings and graphs for report submission.
• Experience in merging datasets using Data step and Proc SQL (inner and outer Joins).
• Exported transport files using Proc Copy.
• Developed SAS macros within the programs.
• Experience in annotating the blank CRF manually and writing specifications using CRF and SAP.
• Developed SAS programs for statistical analyses and data displays.
• Assisted in writing analysis plans including specifications for tables and listings.
• Maintained appropriate study application documentation.
• Developed SAS macros within the programs.

Environment: WINDOWS, UNIX, ORACLE,BASE SAS, SAS/STAT, SAS/GRAPH, PROC SQL, SAS MACROS and SAS/ODS.

Confidential, Houston, TX (Jan 2009- Dec 2010)
Clinical SAS Programmer

Role & Responsibilities:

• Performed programming and analysis for Phase I and II of clinical trial data related to therapeutic areas Pain and Diabetic study.
• Produced customized reports using Proc Report.
• Written table and listing specifications.
• Checking, editing and writing macros.
• Generated the datasets and developed reports as per the SAP.
• Extracted raw data from Oriclinical database and excel using SAS/SQL and Proc Import Wizard.
• Involved in the data analysis of safety and efficacy data.
• Developed reports according to 21 CFR part 11 requirements for FDA submissions.
• Expertise in applying mapping logic and creation of CDISC domain datasets.
• Worked on adhoc analyses as per user’s guidelines and requests.
• Validated tables, listings, graphs and datasets using double programming.
• Involved in creating analysis datasets for different data and statistical analysis.
• Wrote programming specs and validation specs for junior programmers.
• Well experience in writing new macros and modifying the company macros as per the specifications.
• Experience in windowing the data to determine the planned visits and calculate missing data using LOCF approach.
• Standard company Macros used for generating Graphs and Listings.
• Conducted ANOVA and Regression analysis.
• Debugged the macros by using mlogic, mprint and symbolgen options.
• Produced various graphs using Proc Gplot and Proc Lifetest.
• Demographic reports are generated for different groups of patients.
• Good working knowledge on SAS functions, arrays, formats, delimiters and labels.
• Import procedure used to generate temporary and permanent SAS datasets from txt, csv and excel files.

Environment: WINDOWS, UNIX, ORACLE,BASE SAS, SAS/STAT, SAS/GRAPH, PROC SQL, SAS MACROS, SAS/ODS and SAS/ACCESS.

Confidential, Houston, TX (Jul 2007- Oct 2008)
SAS Programmer

Role & Responsibilities:

• Experience in production of functional tables, listings and figures that are related to Phase I and II of clinical trial data.
• Used Proc Report to create customized reports.
• Generated tables, listings and graphs for report submission.
• Effectively used SAS functions, arrays and formats for generating Tables.
• Created the datasets and developed reports as per the statistician requirements.
• SAS ODS used to create PDF, RTF and HTML reports.
• Proc Means, Univariate, Reg, Logistic, Anova and Glm used extensively for various analyses.
• Produced statistical tables and listings for report submission.
• Generated Kaplan-Meier survival plots using Proc Lifetest and Proc Gplot.
• Produced reports according to 21 CFR part 11.
• Experience in grouping the clinical sites for analysis purpose.
• Validated tables, listings and graphs using double programming.
• Helped in data cleaning, data validation and identification of bad data.
• Used company macros effectively and modified the macros for annotation process.

Environment:BASE SAS, SAS/STAT, SAS/GRAPH, PROC SQL, SAS MACROS, SAS/ODS, WINDOWS and MS EXCEL.