Summary:

• Overall 6+ Years of industrial experience with 4+ Years of experience in SAS analysis in pharmaceutical companies

• Experience in Analysis, Design, Development and Validation of applications.
• Expertise in analyzing and coordinating clinical trial data, generating reports, tables, listings and graphs using SAS in accordance with the Statistical Analysis Plan(SAP),Standard Operating Procedures(SOPs) and departmental guidelines.
• Strong knowledge involving all phases (I-IV) of clinical trials.
• Trained in Good Clinical Practice (GCP), Regulatory Compliance and FDA Guidelines.
• Strong experience on Base SAS, SAS/Stat, SAS/Access, SAS/Graphs and SAS/Macros, SAS/ODS and SAS/SQL in Windows Environment.
• Optimized performance using Data Validation and Data cleansing on Clinical Trial data using Statistical procedures like PROC FREQ, PROC MEANS, and PROC UNIVARIATE.
• Generate reports using PROC REPORT, DATA_NULL_ and PROC TABULATE for customized report writing.
• Expertise in Data archival and Data migration, ad-hoc reporting and code utilizing SAS on UNIX and Windows Environments.
• Expertise in producing RTF, PDF, HTML files using SAS ODS facility.
• Experience in extracting, manipulating data, and creating Data Sets from various sources like Excel, flat files, Oracle database, Access database using PROC IMPORT techniques and SQL pass through facility.
• Excellent ability in problem solving, data analysis, complex reports generation.
• Good knowledge of using SAS Enterprise Guide.
• Proficiency in understanding of Study Protocols, SAP (Statistical Analysis Plan), and CRF.
• Quick learner and excellent team player, consistently meeting deadlines and can work under pressure.
• Highly motivated individual with excellent organizational and interpersonal skills.

• Bachelor’s degree

Technical Skills:

SAS Tools: SASV8, V9, SAS/BASE, SAS/ACCESS, SAS/SQL,
SAS/MACROS, SAS/GRAPH, SAS/STAT, SAS/REPORT, SAS/ODS.
Databases: Clinic-Trial, SQL server.
Operating Systems: Windows98/2000/XP
Languages: SAS, SAS Enterprise Guide.
Office Tools: MS-OFFICE, Word, Excel, PowerPoint, HTML.
Core Competencies: Statistical programming, Clinical Trials, Data Analysis, Reports Development.

Professional Experience:

Confidential, NJ Apr’11 – Mar’12
Statistical Programmer/Analyst
Merck is one of the largest pharmaceutical companies in the world and has a global influence. It is a research-driven company that discovers, develops and markets innovative products for healthcare all over the world. As a statistical programmer, I was involved in two clinical trial projects that were in Phase II and Phase III stages. The projects primarily required developing and validating tables and analysis datasets.

Responsibilities:

• Understanding the requirements of the Application
• Created and edit check programs to find data discrepancies in raw datasets provided by Data Management Group.
• Worked with the Statisticians, Data Managers to provide SAS programming in analyzing Clinical Trial Data.
• Generated final study reports, tables, listings and graphs by using PROC Tabulate, PROC Sql, and PROC GChart.
• Validating the datasets and comparing the results to that of source programmers output.
• Reviewed data from clinical trials and developed a strategy for how to present results to FDA.
• Generated CRT (Case Report Tabulation) datasets using CDISC standards for FDA regulatory submissions.
• Preparation of Integrated Safety (ISS), Integrated Summary Efficacy (ISE), Electronic Common Technical Document (e-CTD) and packages and DEFINE.PDF for the analysis of datasets using the Annotated CRF’s.
• Worked on the summary of clinical data like Demographic, Adverse Events, Serious Adverse Events, and Related Adverse Events leading to Discontinuation.
• Developed various forms of outputs like RTF, HTML, PDF files using SAS ODS facility.
• Provided reports with minimum risk and optimum result.
• Participated in project meetings, presentations and updating research findings.

Confidential, San Diego, CA Feb ‘10 – Mar’11
Statistical Programmer/Analyst
Biogen Idec creates new standards of care in oncology, neurology and immunology. It is a global leader in the development, manufacturing and commercialization of novel therapies. Biogen Idec transforms scientific discoveries into advances in human healthcare. As a SAS programmer, Involved in Phase II and III clinical data Analysis and generated Tables, Listings and Graphs. Idec’s goal was to develop two major commercial Drugs- one in certain B-cell non-Hodgkin’s lymphomas, the other in autoimmune and inflammatory diseases. As a SAS programmer, Involved in Phase II and III clinical data Analysis and generated Tables, Listings and Graphs.

Responsibilities:

• Understanding the requirements of the Application
• Created Analysis Datasets, Summary Tables, Listings and Plots according to the specification of the study for statistical analysis
• Modified the datasets according to the requirements of the statistician.
• Data validation and quality control check of the displays and datasets according to the different QC levels.
• Investigate, prepare, analyze, and validate data for down streaming Modeling and Analysis.
• Trained in Good Clinical Practice (GCP), Regulatory Compliance and FDA Guidelines.
• Extracted data from Oracle database using Pass through Facility.
• Extensively worked on PROC REPORT and PROC TABULATE to produce reports for the purpose of validation.
• Involved in writing code using data step programming and macros to extract, clean and validate date from external source.
• Extensively worked with complex and huge datasets, and generated reports in various formats such as PDF, RTF, HTML and list files using SAS ODS facility.
• Validating the datasets and comparing the results to that of source programmers output.
• Attended project team meetings, interacted with Bio –Statisticians, Data Managers, and Clinical Research Managers.

Confidential, Hawthorne, NY Aug ‘08 – Jan ’10
SAS Programmer Consultant
Acorda is a Contract Research Organization (CRO) whose mission offers a full range of clinical research services for Phase I-IV for different pharmaceutical companies.

• Review and acquired knowledge about documents related clinical trials like clinical protocol, SAP, Clinical Study Report and aCRF (Annotated CRF).
• Worked with Clinical Data Management team for creating annotated CRF.
• 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.
• Participated in Weekly Meeting with Team Lead, Co-workers to discuss about the work progress and queries regarding Project.

Confidential, Ahmadabad, INDIA Oct ‘06 – Jul ‘08
SAS Programmer

• Designed reports for key health care modules like administration IP billing OP billing and pharmacy as per the requirements of the higher authorities.
• Created reports for finding out the load balance of the patients for particular time intervals for analysis of business.
• Tested and debugged SAS programs against the test data.
• Processed the data in SAS for the given requirement using SAS programming concepts.
• Imported and Exported data files to and from SAS using Proc Import and Proc Export from Excel and various delimited text based data files such as .TXT (tab delimited) and .CSV (comma delimited) files into SAS datasets for analysis.
• Used statistical analysis procedures in the generation of reports periodically for analyzing the business using SAS STAT procedures such as Regression Univariate, Correlation.
• In Data Transformation and Manipulation process, extensively used procedures like SQL, Transpose, Tabulate, Copy, Sort, Datasets etc.

Note: Professional and personal references are available on request.