SUMMARY

• 7+ years of work experience in SAS Programming, Clinical Trials (Phases II and III), Reporting Tools, Oracle, PL/SQL and UNIX and FTP.
• Strong experience in Base SAS, SAS/MACROS, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STAT, SAS/ODS and SAS/SQL in Windows and UNIX environments.
• Experience in Data manipulation and producing reports employing various SAS procedures likePROC SQL, PROC REPORT, PROC TABULATE, PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC SUMMARY, and PROC CONTENTS, PROC TRANSPOSE, PROC SUMMARY, PROC GLM.
• Experience in producing RTF, PDF, HTML files using SAS ODS facility.
• Experience in Data Cleansing, Data Archival, and Data Migration, ad - hoc reporting and coding utilizing SAS on both UNIX and Windows Environments.
• Experienced in preparation of SAS datasets, Tables, Listings, and Graphs.
• Expertise in analyzing and reporting various phases (Phase me-IV) Of Clinical Trials using tools like BaseSAS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/MACRO, SAS/ACCESS and SAS/ODSin UNIX and Windows environment.
• Working noledge ofGeneral linear models, Categorical data analysis, Survival analysis, Multivariate analysis,Design of experiments, longitudinal data analysis, randomized trial designs and survey design and analysis.
• Experience in providing statistical support for clinical studies, includingdesign of studies,selection of appropriate statistical methodologies and tests,sample size and power calculations, randomization,statistical analyses, and interpretation of results.
• Experience indebugging and testing SAS programsto check and process data, generate graphs, tables and listings in analysis system.
• Individually capable of developing new SAS Programs and/or enhancing existing SAS programs from protocols and SAP’s.
• Proficient in Statistical Methods and procedures.
• Working noledge with CDISC SDTM, Preparation of Integrated Safety (ISS), integrated Summary Efficacy (ISE), Electronic Common Technical Document (e-CTD).
• Trained in Good Clinical Practice (GCP), Regulatory Compliance and FDA Guidelines.
• Proficient in understanding of Study Protocols, SAP (Statistical analysis plan), and CRF.
• Excellent ability in problem solving, data analysis, complex reports generation.
• Extracted and manipulated data from Oracle data base using SQL Pass through facility.
• Quick learner and excellent team player consistently meet deadlines and can work under pressure.
• Highly organized and dedicated with a positive attitude and self motivated. Good written, oral, and interpersonal communication skills.

TECHNICAL SKILLS

Operating Systems: Windows 95/98/00/NT, MVS, UNIX

Editors: Exceed, NEdit, Vi, Emacs, Hessling Editor.

SAS Skills: Base SAS, SAS/MACRO, SAS/Connect, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/Access, SAS Enterprise Guide 4.0.

Databases: Oracle 10g, MS Access, MS Excel, SQL Server 2005, DB2

Programming Languages: C, PL/SQL

Mainframe Tools: MVS

Web Technologies: HTML, Cognos

SAS Procedures: Print, Transpose, Contents, Means, Chart, Plot, Tabulate, Univariate, Summary, Sort, Reg, SQL, Copy, Freq, Forms, Upload, Download, Formats.

Statistical Packages: SPSS

PROFESSIONAL EXPERIENCE

Confidential, Wallingford, CT

SAS Programmer

Responsibilities:

• Responsible for providing Clinical SAS programming and analysis support for clinical studies across multiple protocols for the submissions like CSR and Safety.
• Extensively created Analysis Datasets, Summary Tables, Listings and Plots according to the specifications of the study based on statistical analysis Plan.
• Modified Tables and Datasets in Phase II-III study according to the requirements of the statisticians.
• Produced Ad hoc reports of various kinds like Listings, Tables, and Figures (TLGs/TLFs) using Proc Report, Proc Tabulate, Data Null technique, Proc Gplot etc.
• Validated analysis data sets and SAS outputs with other programmers’ outputs and mockups in SAP using PROC COMPARE, PROC CONTENTS, and PROC FREQ. Created formats for the coded data and used PROC SQL for data validation.
• SAS macros were successfully used to create new programs and modified existing SAS programs to make them portable as well as for consistency of results.
• Extensively used procedures like PROC SUMMARY, PROC UNIVARIATE, PROC MEANS, PROC TABULATE, PROC GPLOT, PROC FREQ, PROC COMPARE, PROC REPORT and PROC TRANSPOSE and other statistical procedures like PROC ANOVA, PROC GLM AND PROC REG, PROC PHREG, PROC CORR, and PROC LIFETEST.
• Imported external files like Excel files, text files, and Database files into SAS data sets using INFILE, LIBNAME, PROC IMPORT, SAS/Macros, and SAS/Connect, etc.
• Worked on different clinical trials data like Patient Demography and Characteristics, Medical History, Vital signs, Adverse Event (AE), Physical examination, Laboratory data, Dosing, Concomitant medication, Survival Analysis.
• Validation of datasets and TLGs and peer reviewing of the fellow programmers’ code.
• Developed and validated standard and custom data listing, datasets, summary tables, and Graphs as per requirement and standard protocols and involved in study designs.
• Contributed to Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE) and Reports for clinical Studies.
• Involved in problem solving, data analysis, and complex report generations.
• Developed various forms of out puts, RTF, PDF, HTML files using SAS ODS facility.
• Extracted data from Oracle data base using SQL Pass through facility.
• Developed programs using Base SAS & SAS/Macros to extract data from oracle tables.
• Reviewed data from clinical trials and developed a strategy for how to present results to FDA.
• Created analysis datasets based on the guidelines provided in the Data Definition Tables (DDT) following the CDISC standard. Used SDTM model (3.1.1)/ ADAM for domain creation and CDISC compliant analysis datasets.
• Used Proc CDISC for verifying compliance of datasets with CDISC standards and electronic submissions.
• Efficient in maintaining working relationships with clients and internal project members, including data managers, research scientists, and other statistical programmers.
• Ability to work on multiple projects simultaneously and meet the deadlines as and when required.

Environment: SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS/ACCESS, SAS/ODS, UNIX MS Access, Excel.

Confidential, Pennington, NJ

Clinical SAS Developer

Responsibilities:

• Provided SAS Programming and analysis support for phase me and III (oncology) clinical trials
• Co-worked with Statisticians as a primary SAS programmer to analyze initial data sets and create tables, listings and figures (TLFs) for clinical trials.
• Created tables, graph to generate clinical study reports for the collected requirement from the statisticians referring to the Statistical Analysis Plan (SAP).
• Extracted data from ORACLE database and involved in cleaning the data (data cleansing) using various edit check techniques.
• Used procedures like PROC TRANSPOSE, PROC SORT, etc in Data transformation and Manipulation processes.
• Extensively used Proc SQL, Proc Transpose, Proc Format, Proc Means, Proc Univariate, Proc Freq, Proc Printto and Proc Compare for checking the assumptions and conducting Statistical Analysis.
• TEMPEffectively developed SAS code for modeling data and implemented SAS/STAT procedures such as Proc Lifetest, Proc lifereg, Proc Phreg, proc reg and Proc Glm for Survival analysis, logistic regression analysis and other statistical analyses.
• Produced Ad hoc reports of various kinds like Listings, Tables, and Figures (TLGs/TLFs) using Proc Report, Proc Tabulate, Data Null technique, Proc Gplot etc.
• Used SAS ODS to report outputs in different formats like RTF, PDF, and HTML
• Validated analysis data sets and SAS outputs with other programmers’ outputs and mockups in SAP using PROC COMPARE, PROC CONTENTS, and PROC FREQ. Created formats for the coded data and used PROC SQL for data validation.
• SAS macros were successfully used to create new programs and modified existing SAS programs to make them portable as well as for consistency of results.
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.

Environment: Windows XP, Oracle 9i, SASV9.1.3, Base/SAS, SAS/Access, SAS/Macro, SAS/STAT

Confidential, Austin, TX

SAS Developer

Responsibilities:

• Migrated SAS programs and the data from Mainframe to UNIX Environment.
• Involved in coding, testing and enhancing the change of requests and work requests to the General Ledger system.
• Utilize SAS database management, querying, reporting, and analysis techniques to store, organize, and manipulate data in efficient manners.
• Extract data from SQL reporting and production database.
• Investigate, prepare, analyze, and validate data for downstream Modeling and Analysis.
• Extensively worked with complex and huge datasets, generated reports in various formats such as PDF, RTF, HTML, CSV and list files.
• Extensively worked on quality checking of SAS programs and the data transferred from mainframe to Unix, Mostly by using proc compare and Editpadpro6 compare
• Extensively created Batch jobs to run the sequential programs and Developed macro programs to automate the batch jobs
• Extensively worked on refreshing the data on mainframe, UNIX and oracle schemas as needed for testing.
• Highly involved in oracle data base design and implementation as the data base is converted from mainframe VSAM to Oracle database.
• Developed SAS code to connect the Oracle by using Proc SQL to create, modify and update oracle tables.
• Developed SAS code to Read, Write, and Update and Delete the oracle tables and views for testing the data flow
• Run the PL /SQL scripts to refresh the schemas and update the oracle tables and create views for testing.
• Data reviewed and validated the oracle tables once the data in the tables are updated.
• Work experience in updating or creating documentation of code and high level systems documentation.
• Attended regular team meetings and contributed valuable ideas to implement the project successfully.
• Awarded with Certificate of Excellency by CEO for the successful completion of the project.

Environment: SAS, UNIX, Oracle, DB2, MVS, Windows NT, Cognos.

Confidential, San Diego, CA 

Clinical SAS Programmer

Responsibilities:

• Create Analysis Datasets, Summary Tables, Listings and Plots according to the specifications of the study for statistical analysis.
• Modify Tables and Datasets in Phase II-III study according to the requirements of the statisticians.
• Data validation and quality control check of the displays and datasets according to the different QC levels.
• Responsible for providing SAS programming and analysis support for Phase II and Phase III clinical study.
• Worked extensively to generate SAS Analysis data sets, listings, safety reports for cross-functional teams for Phase II to III Data.
• Worked on the summary of clinical data like Demographic, Adverse Events (AE), Serious Adverse Events (SAE), Adverse Events by System Organ Class and Preferred Term, Related Adverse Events and Adverse Events Leading to Discontinuation.
• Extensively worked on PROC REPORT to produce reports for the purpose of validation.
• Evaluated and provided input on SAP for individual and pooled clinical data sets.
• Involved in problem solving, data analysis, and complex report generations.
• Developed various forms of out puts, RTF, PDF, HTML files using SAS ODS facility.
• Extracted data from Oracle data base using SQL Pass through facility.
• Experienced in SAS Edit checks with Automated Quarry generation and validate clinical datasets.
• Used statistical procedures like PROC MEANS, PROC UNIVARIATE, PROC FREQ and PROC PHREG for analysis.
• Generated tables, listings and graphs according to Protocol and Statistical Analysis Plan (SAP) using PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC REPORT, PROC GCHART and PROC GPLOT Procedures.
• Created SAS Customized Reports using the Data Null technique.
• SAS/STAT procedures such as UNIVARIATE, FREQ, and MEANS were used to carry out analyses and the SAS REPORT procedure is generally used to display results.
• Used SAS ODS to produce HTML, PDF and RTF format files.
• Involved in generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) analysis Datasets, Tables, Listing and Graphs for multiple trials.

Environment: SAS/BASE, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/MACRO, Windows