Over 6 years of extensive industry experience in analysis, design, development of Statistical data models including data extraction and manipulation, writing macros and reporting on various projects, for Financial, Insurance, Pharmaceutical, Medical and Healthcare industries.

SUMMARY:

• Experience in SAS/BASE, SAS/SQL, SAS/MACROS, SAS/ODS, SAS/STAT, SAS/ACCESS, SAS/CONNECT.
• Comprehensive skills in working with Base SAS, SAS/MACRO in Windows environments.
• Skilled in SAS Programming, merging SAS Data Sets, Macro Facility, Preparing Data, PROC, Producing Reports, Validating Reports, SAS Formats, Storing and Managing Data in SAS Files.
• Well versed with creating HTML Reports for financial data using SAS ODS facility, Proc Report and SQL pass through facility.
• Successfully increased portability of existing SAS programs and created new programs using SAS Macro variables to improve efficiency and consistency of results.
• Extensive experience in Clinical Data Validation
• Knowledge of complete new drug & device release process from IND submission to FDA approval, which includes Clinical Trials (Phases I-III), preparation of IND, NDA, safety reviews, adverse event report reviews, risk factor, integrated safety and efficacy summary (ISS & ISE) for FDA submission
• Thorough experience in data extraction and sorting from various databases like Oracle, DB2 and MS Access etc., using SQL Pass through facility, library reference statements, etc
• Solid understanding of statistical concepts and proficient use of various statistical and stored procedures like proc SQL, proc report, proc freq, proc means, proc tabulate, proc transpose, proc plot, proc chart, proc contents, proc dataset, proc format, proc import, proc export, proc print, proc sort, proc ANOVA, drop ,keep, retain, date manipulations, formats, in formats and SAS/STAT procedures

TECHNICAL SKILLS:

• SAS Tools : SAS/BASE, SAS/GRAPH, SAS/ODS, SAS/ACCESS, SAS/STAT, SAS/MACROS, SAS/SQL
• Programming Languages : C, SQL, and HTML
• Platforms : UNIX/AIX, Windows (95, 98, 2000, XP, Vista), MSDOS
• Database : MS ACCESS, SQL
• Microsoft Tools : MS Office, MS Excel

Confidential, Durham,NC Dec 2009 – Till Date
Sr. SAS Programmer
Provided technical expertise for the conduct of clinical trials, acted as an internal subject matter expert in specific areas providing technical support and expert advice, and worked independently to support various programming activities related to clinical systems,analysis,reporting, the applications/systems within eClinical technologies.

• Developed macros from scratch and updated pre-written macros.
• Extensively used SAS STAT procedures for generating reports.
• Performed Quality Gate check
• Assisted in the production and QC of analysis plans, TLF mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents.
• Used efficient programming techniques to produce and/or QC derived datasets, tables, figures and data listings.
• Coordinated project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
• Coordinated the programming team to successful completion of a study within given timelines . Provided technical support and advice to the internal team.
• Ensure quality control (QC) on all process and technical activities related to trial set-up and maintenance.
• Proactively participated in process/quality improvement initiatives.
• Developed wider knowledge of areas of Safety Reporting, SAS, SQL, and other programming language usage and processes within the biostatistics, and medical arenas.
• Assisted project teams in the resolution of problems encountered in the conduct of their daily work.
• Performed medium size to complex ad-hoc programming tasks.
• Generated tables, listings, and graphs for FDA submissions as per 21 CFR Part 11 guidelines.
• Worked on multiple projects simultaneously
• Created analysis datasets using ADaM standards
• Reviewed study SAPs and Protocols.
• Created Tables, listings and graphs in RTF formats.

Environment: UNIX,SAS/SQL, SAS/ETL, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/STAT, MS-EXCEL.

Confidential, PA.March 2009 – Dec 2009 
SAS programmer Analyst II
Confidential with the headquarters based in Dublin, Ireland is the fourth largest CRO and constantly expanding in the clinical research market. Currently working with the DIS group, which acts as a liaison between the Data management and Biometrics. Involved in extracting data, performing data transfers and preparing SAS datasets according to CDISC SDTMv3.1.1 for studies build in Oracle clinical, Inform and Rave.

• Troubleshoot, diagnose and provide timely resolution of issues raised by data management.
• Carry out Annotations of CRFs based on CDISC SDTMv3.1.1 and prepare the related transfer specifications.
• Extract, format and transfer data according to project specifications. Involved in preparation of SDTM compliant SAS datasets.
• Program and validate edit checks and listings as specified.
• Provide input in terms of process improvement and further standardization of work practices and procedures.
• Provide technical support for ad hoc programming requests.
• Assist in the design and maintenance of clinical databases, program edit checks per specifications and provide relevant technical support on or off site as required.
• Attend client/project meetings and communicate with client, as required.
• Create and maintain study documentation, as required, in accordance with SOPs.

Environment: SAS 9.1 (SAS/Base, SAS/SQL, Macros), SQL, InForm and Windows NT 

Confidential, Charlottesville, VA August 2008 - February 2009
Position: Analysis Programmer (SAS) 
Responsibilities:

• Involved in SAS programming with Clinical Trials data for Phase I-III Clinical Trials in Oncology.
• Developed dynamic SAS programs using SAS Tools like SAS/Base, SAS/Macros.
• Programmed edit checks and analysis for clinical studies.
• Developed new SAS programs and modified existing SAS programs.
• SAS Macros were used extensively in analysis of standard clinical data and generated reports, graphs, listings, summaries and tables.
• Developed, maintained and utilized standard SAS naming conventions for macro library supporting consistency and reusability of programs.
• Proc SQL is being used extensively.
• Developed procedures to standardize analysis programs, including a macro library.
• Developed Tables, Listings and Figures for various on-going studies.
• SAS Macros were used extensively in analysis of standard clinical data and generated reports, graphs, listings, summaries and tables.
• Involved with the QC and Validation of SAS programs.

Confidential, San Antonio, TX January 2007 – July 2008 
SAS Programmer 
The Project involved a detailed study on patients suffering from Breast cancer. The Primary objective of this project was to study the effect of various compounds on patients suffering from advanced stages of Breast cancer. It is a study of randomized, placebo controlled, and double-blinded to provide the most convincing evidence for the safety and efficacy of the drug.
Responsibilities:

• Processed data using different statements like set, sort, merge and update to prepare final analysis dataset.
• Produced data listings, summary tables and graphics for interim and final analysis and publications.
• Provided data in SAS transport files, and other appropriate deliverables and documentation for regulatory submissions.
• Participated in maintenance of software applications. Identifying enhancements and new features. Participated in requirement reviews. Took raw data and creating data sets for all programmers.
• Performed validation programming on clinical trial data using SAS MACROS.
• Created base macros to run reports. Creating standard reports to use across studies and creating base programs to set up data.
• Extensive use of Data _Null_, Univariate, Summary, Means, Freq, and Chart procedures Ascertaining quality and standards for the code changes made.
• Tested and debugged against the test data.
• Responsible for locating appropriate databases for projects.
• Responsible for implementing and monitoring clinical research trials, tracking study progress, and ensuring data integrity.
• Successfully handled multiple projects at a time.

Environment: SAS/Base, SAS/STAT, SAS/GRAPH, SAS/Access, PL/SQL
Confidential, San Carlos, CA October 2005 - December 2006 
Clinical SAS Programmer 
Confidential is involved in discovery, development and commercialization of novel drugs for acute cardiovascular and cancer therapy. The company’s aim is to develop secreted proteins as bio-therapeutic drugs and antibodies for targeting cancer and immune related disorders.

Job Responsibilities:

• Provided SAS programming for Clinical trials.
• Maintained SAS Datasets that are extracted from an Oracle Database.
• Converted CSV and Excel tables into SAS data sets
• Used SAS macros for data cleaning and reporting
• Created SAS Macros and Graphs and produced reports using Proc Report
• Created RTF, PDF and HTML listings, tables and Reports using SAS/ODS
• Created Summary and Tabular Reports using Proc Report.
• Created automated annotated-case report form (a-CRF) from CRFs provided by clinical Data Management using SAS and medical references dictionaries such as MedRA, WHODrug
• Used routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintaining existing ones.
• Generated listings, tables and figures for study reports and NDA applications in FDA submissions.

Environment: Windows 2000 Server, SAS BASE, SAS MACROS, SAS ODS, SAS SQL, SAS Access, SAS GRAPH, SAS STAT, Excel, Access, Oracle 9i

Confidential, Hawthorne, NY Oct 2003 – Aug 2004
SAS Programmer 
Confidential is a biotechnology company focused in the development of therapies to restore neurological function in people with spinal cord injuries.
Responsibilities:

• Worked on Phases II and III of clinical trials for Spinal Cord Injuries (SCI) and Multiple Sclerosis (MS).
• Generated tables, listings, and graphs for FDA submissions as per 21 CFR Part 11 guidelines.
• Extracted data from Oracle using SQL procedure’s pass-through facility.
• Created intermediate datasets with the required formats and created the study format catalog.
• Developed validation programs for Clinical data.
• Managed macros for initialization and statistical analysis and for generating multiple graphs per page and output as word document.
• Used Macro libraries routinely in many SAS programs.
• Imported and exported data from other data sources such as Excel, Access.
• Performed data validation, quality review of programs coded by other programmers and checked for data consistency.
• Worked with Case Report Forms (CRFs) during database design.
• Created reports using ODS in various file formats such as RTF, PDF and HTML.
• Developed reports using MEANS, FREQ, REPORT, UNIVARIATE and SQL.

Environment: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/ACCESS, SAS/ODS, SAS/SQL and UNIX, MS Office.

B.Tech in Mechanical Engineering
Confidential University