SUMMARY
5 yearsof professional IT experience in application development and programming, of which three years of experience in clinical trials.

• Certified SAS Programmer with experience in Analysis, development, testing and validating the applications.
• Worked on multiple projects for multiple clients like Novartis, Sanofi Aventis, Schering Plough, Amicus etc. on different therapeutic areas (Respiratory, CNS, Immunology, Gastroenterology etc.)
• Demonstrated experience in SAS/BASE, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/MACRO and SAS/ODS.
• Worked in conjunction with CROs to perform Clinical Data Analysis for Phase I, II and III Protocols and strong experience in CDISC SDTM standards.
• Expertise in analyzing and coordinating clinical trial data, generating reports, tables, listings and graphs.
• Optimized performance using Data Validation and Data Cleaning on Clinical Trial Data using Statistical procedures like Proc Format, Proc Report, Proc Means, Proc Summary, Proc Freq, Proc Univariate, Proc SQL, Proc Import, Proc Tabulate, Proc Mixed and the _NULL_ data step.
• Familiar with various statistical theories and applications such as ANOVA specifically designed for 'analysis of variance' on balanced data, predictive solution models such as General Linear Regression Models & Regression Analysis.
• Familiar with 21 CFR Part 11 compliant Statistical Process Control Systems, International Conference on Harmonization (ICH) guidelines and Good Clinical Practice (GCP) and Coding Dictionaries such as MedDRA.
• Ability to work on multiple projectssimultaneously and meet the deadlines as and when required.
• Possess strong analytical, effective communication, interpersonal, organizational and execution skills, essential for successful liaisons with Business Owners, Technical Teams and Quality Assurance groups, for fulfilling corporate goals and ensuring that customer expectations are met with respect to timeframes, software/data quality and business value.

TECHNICAL SKILLS

SAS Tools : SASV8/V9, SAS/BASE, SAS/SQL, SAS/MACROS,
SAS/GRAPH, SAS/STAT, SAS/ODS.
Databases : Oracle Clinical, SQL server.
Operating Systems : Windows 2000/NT/XP.
Languages : C/C++, Java, ASP.Net, C#
Office Tools : MS-Word, Excel, PowerPoint.

PROFESSIONAL EXPERIENCE

Confidential, Jun 2007 to Till date

117 Campus Drive, University Squire,
Princeton, NJ

SAS Programmer
Advanced Biomedical Research Inc (ABR) provides top quality, solutions-driven, specialized outsourced services for the global healthcare community. ABR is a leading solutions-driven CRO committed to therapeutic focus andoperational expertise to deliver clinical trial services of the highest quality for biopharmaceutical and medical device companies. The team evaluates the unique needs of each client and provides solutions catered to their specific project requirements.

Responsibilities:

• Responsible for manipulation of clinical trials data using SAS in a Windows environment.
• Major work is focused on creating Tables, Listings and Figures, data extraction, cleaning, and derivation of Derived datasets, Validation and documentation of SAS codes.
• Extract and Transform the raw data into analysis dataset in the desired format as per the CDISC standards.
• Review the Protocol, Case Report Forms (CRFs), Statistical Analysis Plan (SAP) and Develop programs to create TLG's as per the SAP shell.
• Created derived dataset's Specification files for safety and efficacy data.
• Perform Validationon Derived datasets, Tables and Listings following the SOPs and document the same.
• Create Transport files using PROC COPY, CPORT etc and create the Define.pdf files for CRTs.
• Create Ad-hoc reports as per client requirements.
• Create and modify existing macros to meet the client needs.
• Database Creation and Table Programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Performing statistical analyses using various SAS/STAT procedures (MIXED, GLM, ANOVA, REG, CORR, FREQ, UNIVARIATE, MEANS etc) according to SAP and requirement of studies.
• Proficient in producing Reports through ODS either in HTML, PDF or RTF formats according to the client specifications and good knowledge of CDISC standards.
• Extensive use of PROC SQLto perform queries and join tables.
• Work closely with Statisticians, Data Management Associates, Oracle Clinical DBA, Medical Writers and other Team Members.

Environment:
SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros, Windows XP, MSOffice.

Confidential, Edison, NJ Nov 2006 to June 2007
SAS Programmer

Worked on in house SAS projects for many Phase I, Randomized Double Blind studies and processed many PK/PC data.

Responsibilities

• Generated SAS Data Sets by converting the raw clinical trial data and subject related records from the CSV, delimited txt files and Excel Work Sheets.
• Created Analysis data sets from the raw data sets of various domains and derived variables.
• Converted / Extracted SAS files into Transport files and vice versa.
• Performed TLG programming, using SAS Procedures such as SUMMARY, MEANS, UNIVARIATE, FREQ, SORT, PRINT, TABULATE, PLOT, CHART and REPORT to compute elementary statistical measures, and produce data listings, tabulations & graphical displays.
• Generated Efficacy and Safety tables (Adverse Events, Patient profile, Demographic listing, Vital Signs, lab Descriptive, Reason for withdrawal by treatment) using SAS Base & Macro facilities, involved in data transformation (sort, merge) utilities, options, functions & formats, used within Macros, PROC steps, DATA steps & ODS statements.
• Proficient in developing VALIDATION programs for analysis datasets using PROC COMPARE.
• Generated output files in RTF, HTML & PDF format using SAS ODS.
• Used various character functions such as SUBSTR, TRIM and SCAN functions, searched for strings using INDEX function and created new formats using PROC FORMAT.

Environment: SAS v8.2, Windows XP, MSOffice.

Confidential, Kannur, India Jan 2005 - July 2005

Analyst Programmer

Actively involved in the development of a full fledged portal for Kaashyap Radiant Systems consisting of different components like Online Registration & SHOPPING CART. It has provision for new user registration, user authentication and paying e-bills through credit cards.

Environment: ASP.NET, C#, SQL Server, Windows XP.

Confidential, Kannur, India March 2003 - Dec 2003

Analyst Programmer

Involved in the development of Computerized Financial Accounting System. This was done for Mascot Handloom Exports, Kannur. This was done by using ASP under MS-Windows Operating System. This package includes preparation of Day Book, Journal, General Ledger & Preparation of Financial Statements.

Environment: ASP, MS-Access, Windows XP.

Education

• Master of Commerce with Statistics as one of the main credit courses
• Post Graduate Diploma in Computer Application (PGDCA)

Certification

• SAS Base Programming from SAS Inc

References: Available up on request.