PROFESSIONAL EXPERIENCE:

• SAS Programmer with pharmaceutical clinical trials Industry experience.
• Experience in Phase I, II, III and IV clinical data analysis. Program, modify and analyze clinical trial data.
• Provided programming for Clinical Study Report creation of analysis data sets, provided programming for ISS in support of New Drug applications, including creation of ISS Analysis Data Sets, programming ISS in-text tables and appendices.
• Provided support for e-submissions, in terms of preparing the statistical review aid package, datasets programs and related documents.
• Developed databases for Ad-hoc report creation, interim analysis, responsible for creating mockup table and listing, generated Safety and Efficacy tables and listings, cleaned the database and developed specification & performed edit/quality checks.
• Participated in all stages of clinical trial study team review meetings including statistical review, presentation, publication and SOP trainings .

TECHNICAL SKILLS:

SAS Tools: SAS V9.1.3, SAS V9.2, Base SAS, SAS/SQL, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/ACCESS SAS/Connect, SAS/Share SAS Enterprise Guide, SAS JMP, SAS Enterprise Miner, SAS Text Miner, SAS Sentiment Analysis Studio, SAS Content Categorization

Operating Systems: Unix, Linux, Windows 7, Windows XP,

Databases: Oracle, Teradata, MS SQL SERVER & MS ACCESS

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

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

Business Intelligence Tools: Tableau, IBM SPSS Modeler, IBM Cognos, Microstrategy

PROFESSIONAL EXPERIENCE:

Title : Statistical Programmer

Organization : Confidential, Fort Worth, TX

Environment : SAS 9.0, SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT, Windows 2000

As statistical programmer, designed and developed statistical and analytical databases for the Clinical Operations Division working on analysis of phase II studies on drugs. Used Base SAS, SAS/STAT, and SAS/Macros to analyze and generate Safety reports for Phases II through Phase III indications

Responsibilities

• Develop programming specifications for derived data sets, listing tables and summary tables, develop and participate in programming and validation efforts; take part in data review and perform other non-statistical ad hoc requests, patient profiles, QA edit checks, including review of data for adherence to protocol.
• Ensure programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting.
• Prepare, document and test required programs and procedure data displays in an efficient manner for inclusion in ISS/ISE, statistical reports and other similar reports.
• Involved in NDA submissions. Generated various reports in accordance with FDA guidelines.
• Provide Clinical Data programming support in the production of analyses, tabulations, graphics, and listings from clinical trial data.
• Perform quality assurance procedures on work performed by others.
• Creating Macros for generating graphs, reports, analysis datasets
• Testing Macros create test plans and user guides.
• Ad-hoc Report Creation, generating tables, listings for statistical analysis
• Performed chi-square test to determine whether the two treatment groups were same with respect to 90-day survival rates

Title : SAS Programmer

Organization : Confidential, Dallas, TX

Environment : SAS 8.2, SAS 9.1.1, Windows NT/2000, SQL, SAS/Macro, SAS/Base, SAS/Access, SAS/SQL, SAS/Connect, CDISC

Responsibilities

• Participated in preparing electronic submissions of FDA.
• Modified/Created SAS programs to generate ISS listings and tables.
• Assisted project manager in cleaning raw data using Proc FREQ.
• Created SAS program for Edit Check dataset.
• Defined variables, merged datasets, created derived datasets, and validated data before processing intensive base SAS programming.
• Reviewed and analyzed data to identify potential data problems, created derived data sets.
• Developed SAS macros for Efficacy studies based on CDISC metadata model.
• Performed analyses on clinical trial data, generating listings, tables, graphs according to SAP.
• Validated output of tables, listings and graphs.
• Used FTP method to pull raw data files into SAS.
• Used functions like Call-SYMPUT, Call SYMGET and Data null for macro variable generation.
• Analyzed data according to Clinical Trials protocol and guideline, using SAS statistical procedures such as MEANS, GLM, REG and created output datasets.
• Used functions trim, scan, substr, day, year month etc.
• Produced HTML, RTF, PDF outputs with ODS.

Title : SAS Programmer

Organization : Confidential

Environment : SAS 8, SAS/BASE, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/EXCEL, ORACLE 8, WINDOWS.

Responsibilities

• Generated datasets, tables, listings, graphs and reports from analysis datasets using SAS tools like BASE SAS, MACROs, GRAPH and STAT.
• Integrated data from various different sources to generate reports and tables for Integrated Summaries of Safety (ISS).
• Improved company efficiency by increasing SAS compilation performance through utilization of the SAS/Macros.
• Implemented documentation and validation practices related to SAS programming per SOP’s.
• Produced quality reports by using procedures like PROC TABULATE, REPORT, and SUMMARY and also provided various statistics using PROC Means, PROC FREQ, PROC UNIVARIATE.
• Involved in NDA submissions. Generated various reports in accordance with FDA guidelines.
• Designed and implemented SAS programs to capture statistics/graphs for statistics concerning regression.
• While using SAS was involved in censoring, survival curves, Kaplan-Meier estimation, Cox regression models and regression analysis.

Title : SAS Programmer

Organization : Confidential

Environment : BASE SAS V8, SAS/MACRO, SAS/STAT, SAS/GRAPH, Windows 98, 2000.

Responsibilities

• Worked on the Clinical Data Analysis Reports extensively using SAS/base, SAS/Macros, SAS/Graphs
• Preliminary data validation (clinical data check), sorting, merging, summarization and tabulation of the data sets are performed to promote further data analysis.
• Generation of summary report of clinical studies, which include risk and odds ratios, and other significant factors.
• Developed numerous ad hoc SAS programs to create summaries and listings.
• Developed SAS jobs for creating graphs, charts and listings using SAS/Graph