SUMMARY

• Worked with Statisticians in analyzing the Clinical Trial Data, generated reports, tables, listings and graphs.
• Experience in extracting data and creating SAS datasets from various sources like Oracle database, Access database, Excel and flat files using Import techniques.
• Strong knowledge involving all phases (I-IV) of clinical trials.
• Worked on SAS/Base, SAS/Stat, SAS/Access, SAS/Graphs and SAS/Macro.
• Experience in developing Macros using SAS procedures.
• Generated reports using PROC REPORT, DATA _NULL_ and PROC TABULATE for customized report writing.
• Experience in developing, validating and implementing SAS programs and produce derived datasets for analysis and generating & documenting tables, listings and graphs for clinical study reports.
• Used ODS to display outputs in HTML, CSV or other file formats.
• Experience in PROC SQL joins and PROC SQL set operators to combine tables horizontally and vertically.
• Optimized performance using Data Validation and Data cleaning on Clinical Trial data using Statistical procedures like PROC FREQ, PROC MEANS, and PROC UNIVARIATE.
• Involved in writing and updating Standard operating procedures (SOP) for reviews and approvals.
• Experience in Ad-hoc programming for clinical and data management departments.
• Knowledge of Programming languages such as C and UNIX SHELL.
• Good understanding of Clinical Trial Phases, clinical protocols/ CRF’s/Annotated CRF’s, ICH and GCP guidelines, NDA, IND, CDISC, MedDRA, 21 CFR PART 11. Familiar with Electronic submission guidelines to FDA.
• Highly motivated individual with excellent organizational and interpersonal skills.
• Possess strong ability to quickly adapt to new applications and platforms.
• Good team leader with strong analytical and communication skills.

Technical Skills

SAS Tools: SASV8, V9, SAS/BASE, SAS/ACCESS, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/STAT, SAS/ODS.
Databases: Oracle Clinical, SQL server, Oracle7x/8x.
Operating Systems: UNIX, Linux, Windows98/2000/NT/XP.
Languages: C/C++, Java, HTML, Java Script.
Application Severs: Web Sphere5.1, Weblogic8.1, Apache Tomcat5.0, JBoss4.0.1.

EDUCATIONAL QUALIFICATIONS
Bachelor’s Of Technology (B.Tech).
Post Graduate Diploma in Computer Applications.

PROFESSIONAL EXPERIENCE

Client:Confidential, SFO, CA May’11 – Sep’11.
Role: Lead SAS Programmer

Responsibilities:

• Developed SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs.
• Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets.
• Extracted data from Oracle using SQL Pass through facility and generated reports.
• Prepared new Datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, and Update, Formats, Functions and conditional statements.
• Involved in writing code using BASE SAS and SAS/Macros to extract clean and validate data from oracle tables. Tested and debugged existing macros.
• The accuracy and integrity of data were verified by performing validation checks written in SAS and
checked for data related errors, outliers, and missing values.
• Performed Data Analysis on the data sets using PROC MEAN, PROC UNIVARIATE, PROC FREQ and PROC TRANSPOSE.
• 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.
• Attended project team meetings, worked with Data Managers, and account Managers as appropriate. Reviewed and provided feedback for Data Integrity Plans.

Environment: SASBASE, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, ORACLE, WINDOWS.

Client:Confidential, Southfield, MI Apr’10 – Apr’11.
Role: SAS Programmer

Responsibilities:

• Generating output files in the form of listing, HTML, RTF and PDF formats using SAS ODS.
• Worked and helped other team members with archiving all the electronic and non- electronic study related documents, data etc., into the clients’ online repository.
• Performed QC (Quality Check) extensively on tasks performed by other team members.
• Extensively used company standard macros.
• Generating Graphs, listings, PDF and RTF files using various Base SAS Procedures.
• Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/ Base and SAS/ Macro facility.
• Analyzing various tables using Data manipulation techniques like merging, appending, concatenating and sorting.
• Extracting data from various databases and creating datasets by modifying pre-defined system level macros and using extracting techniques.
• Good team player and experience with working offsite.

Environment: SAS/Base, SAS/Stat, SAS/ODS, SAS/SQL, SAS/Macros, SAS/ Access, MS-Excel.

Client Name: Confidential, Rahway, NJ Jan’09– Mar’10
Role: SAS Statistical Programmer

Responsibilities:

• Created Analysis Datasets, Summary Tables, Listings and Plots according to the specifications of the study for statistical analysis.
• Modified Tables and Datasets in Phase II-III study according to the requirements of the statisticians.
• Preparation of Electronic Common Technical Document (e-CTD) and Case Report Tabulation (CRT), Packages and DEFINE.PDF for the analysis datasets using the Annotated CRF’s.
• 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.
• Ability to work on multiple projects simultaneously and meet the deadlines as and when required.
• Perform validation on derived datasets and following the standard operating procedures during the validation process.
• Extensively worked on PROC REPORT to produce reports for the purpose of validation.
• Involved in problem solving, data analysis, and complex report generations.
• Used statistical procedures like PROC MEANS, PROC UNIVARIATE, PROC FREQ and PROC PHREG for analysis.
• Extracted data from Oracle data base using SQL Pass through facility.
• Ability to deliver the TLG’s to the clients in the absence of the lead programmer and participating in off-site meetings.
• Active participation in monthly departmental meetings and providing the necessary inputs on how to improve the standards.
• Worked closely with Statisticians, Data managers.
• Extensive experience in working with people across other sites when required.

Environment: SAS/Base, Oracle, SAS/Graph, SAS/SQL, SAS/Macros, SAS/ Access, MS-Excel.

Client: Confidential, San Diego, CA Jan‘08–Dec’08
Role: SAS Programmer

Responsibilities:

• Responsible f or providing SAS programming and analysis support for Phase II and Phase III clinical study.
• Generate tables, listings and graphs, including Patient Demography and Characteristics, Adverse Events and Laboratory data etc.
• Experience in SAS Edit checks with Automated Quarry generation
• 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.
• 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.
• Generated summary reports for ISS and ISE analyses of clinical study for FDA regulatory submissions and publications.
• Preparation of Integrated Safety (ISS), integrated Summary Efficacy (ISE), Electronic Common Technical Document (e-CTD) and Case Report Tabulation (CRT).
• Supported e Submission group in creating Define. PDF, Define. XML files and validate XLM schema and spread sheets.
• Trained in Good Clinical Practice (GCP), Regulatory Compliance, FDA Guidelines, Data interpretation, supporting statistical methodologies and review SAP.
• Proficient in understanding of Study Protocols, SAP (Statistical analysis plan), and CRF.
• Excellent ability in problem solving, data analysis, complex reports generation.
• Attended project team meetings, interacted with Bio-Statisticians, Data Managers, and Clinical Research Managers.
• Extensively worked on Korn-Shell scripts for running SAS programs in batch mode on UNIX.
• Worked with statisticians in generating SAS analysis datasets, data listings, summary tables, and statistical analyses.
• Extensively used Proc Report and Proc Tabulate to create reports.
Environment: SAS/Base, SAS/Stat, SAS/ODS, SAS/SQL, SAS/Macros, SAS/ Access, Perl, UNIX MS `Access, Excel.

Responsibilities:

• Creating OLAP Cubes.
• Scheduling the DI Studio Jobs.
• Created SAS Macros and modified the existing ones relating to multiple studies.
• Maintained appropriate study application documentation.
• Created reports in the style format using ODS statements and PROC TEMPLATE.
• Provided SAS programming and statistical support to clinical studies group on projects.
• Performed Data Validation and Data Cleaning by Peer-Reviewing.
• Experienced in validating programs and in writing competing codes to re-check the statistical values of tables.
• Used SAS Data Integration Studio extensively to develop SAS ETL and summary jobs.
• Proficient in indicating the input data sets, setting, sorting and merging techniques
• Generated Ad-hoc reports and browser viewable reports using SAS/ODS.
• Successfully handled multi-projects/tasks at a time.
• Involved in extensive communication with manager, data management and statisticians.

Environment: SAS/Base, SAS/Stat, SAS/ODS, SAS/SQL, SAS/Macros, SAS/ Access, MS-Excel.

Client: Confidential, India May’03– Jun’05
Role: SAS Programmer

Responsibilities:

• Extensively worked to generate SAS data sets, statistical reports, monthly reports, listings, safety reports for cross-functional teams for Phase I and II of Cardio-Vascular Clinical Trial Data.
• Worked with the Statisticians, Data managers to provide SAS programming in analyzing Clinical Trial Data, generating final study reports, tables, listings and graphs.
• Created and edit check programs to find data discrepancies in raw datasets provided by Data Management Group.
• 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.
• Used SAS/STAT procedures such as UNIVARIATE, FREQ, and MEANS were used to carry out analysis .
• Generating the Repots through SAS Enterprise Guide.
• 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 phase II to phase III trials.

Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros, UNIX.