SUMMARY

• Certified SAS Programmer with over 14 years of experience providing statistical programming support for multiple clinical research projects in Pharmaceutical and Biotechnology industries.
• Advanced SAS programming experience with Version 9: SAS/BASE, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS/CONNECT, SAS/ASSIST, SAS/MACRO, SAS/SQL and SAS/ODS in Windows, Mainframes and UNIX environments.
• Possess extensive knowledge of developing, modifying and maintaining SAS program suites.
• SAS programming experience with selection of appropriate statistical methodology, data analysis, summarization, reporting and submission for all four phases of Clinical Trials: Phase I, Phase II, Phase III and Phase IV (Post - market study).
• Strong understanding of FDA regulations such as CDISC, MedDRA, ICH and GCP guidelines and other Regulatory Submissions (NDA, including an ISS).
• Prepared SDTM Version-3. 1 and AdaM-Version 2.0 data sets as per CDISC standards.
• Customized SAS reports using the Data Null technique and Proc Report for NDA submission as per FDA regulations according to the company guidelines.
• Worked with Clinical Trials data like Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), laboratory data (lab data), physical and vital signs, PK data and Audit Trials. Generated ad-hoc reports as necessary for studying specific trend/ causal effects. Created CRT's (Case Report Tabulations) using CDISC standards for submissions to the FDA. Used XML for data formatting that fits the FDA's strategies for electronic submissions.
• Good understanding of CDISC Standards.
• Knowledge of AERS safety reporting system
• Working experience Health Plan Administration such as PowerMHS.
• Excellent organizational and time management skills
• Possess good analytical and problem solving skills
• Excellent team player with high level of personal initiatives
• Ability to handle multiple tasks simultaneously
• Good Knowledge of Oracle Clinical (OC) and Clintrial.
• Proficient in operating tools like Windows XP/NT, Unix, Linux and MVS

TECHNICAL SKILLS

SAS Tools: Base SAS, SQL, Macro, STAT, Graph, Connect, Access etc.

ETL Tools: Informatica 7.x., Cognos Decision Stream, Data Stage

Data Modeling Tools: Erwin 4.x

Languages: C, PL/SQL, Java 2.0, Shell Scripts, PERL.

GUI/Tools: Developer 2000, SQL*Plus, VB 6.0

RDBMS: Oracle 7.x/8i/10g, MS Access, DB2, SQL-Server 2005, Teradata

OS: Windows 95, 98/NT, MS DOS, Unix, OS/390

Internet Tools: JavaScript, Visual Interdev, HTML,VB Script

Other Tools: Cognos, TOAD 8.x/9.x, SQL Navigator 5.5 and SQL Plus (Database tool)

PROFESSIONAL EXPERIENCE

Confidential, Durham, NC

Senior Statistical Programmer

Responsibilities:

• Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
• Create CDISC ADaM files and SAS export files to use for Electronic Submission from the data received in non-standard form from various sources.
• Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
• Interact with Statisticians and other clinical team, perform ad-hoc analysis and generate outputs according to the requirements.
• Recognizes inconsistencies and initiates resolution of data problems.
• Acts independently to determine methods and procedures on new assignments.
• May provide guidance to other lower level personnel.
• Support lead programmer in generation of analysis datasets, generation of TLFs (Tables, Listings, and Figures), validation of aforementioned data and reports, and maintenance of study documentation.
• Generate and QC summary tables, data listings and figures for in-house analyses of study data or publications using SAS standard coding practices.
• Maintain complete and auditable documentation of all programming activities
• Create SAS standard macros and applications to improve the efficiency of the department.
• Projects: Tables, Listings, and Figures (TLFs’) and SDTM and ADaM programming

Environment: SAS 9.2, 9.3 version, SAS/BASE, SAS/MACRO, SQL, UNIX, MS-Office, WIN-NT etc.

Confidential, Hopewell, NJ

SAS Designer/Developer/Programmer

Responsibilities:

• Designed and developed ADaM domains in compliance to CDISC standards.
• 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, and Listings according to the specifications of the study based on statistical analysis Plan.
• Modified Tables and Datasets in Phase I-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 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.
• 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.
• 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.

Environment: Entimice, SAS 9.3 version, SAS/BASE, SAS/MACRO, SQL, SAS/Connect, SAS/Share, MS-Office, WIN-NT, UNIX etc.

Confidential, Woodcliff Lake, NJ

SDTM Developer/Programmer

Responsibilities:

• Developed and ensured implementation of oncology standards in compliance with CDISC.Developed Tumor SDTM domains.
• Developed and reviewed SAS programs and output for the management and reporting of clinical trial data. Utilized SAS based systems to assist and facilitate Clinical Data Management activities.
• Performed routine quality check on datasets, DDDs, aCRF to ensure their accuracy according to the client specifications.
• Created SAS transport (.xpt) files and converted the transport files into SAS Data Sets.
• Created and validated Macros for the study of Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) for FDA regulatory submissions.
• Used Macros to produce Data Definition Documents (DDDs) for NDA submission and annotated Case Report Forms (aCRF) to the dataset.
• Applied CDISC and FDA regulatory requirements, including the Annotated CRF (aCRF) from the metadata.
• Worked on Phase I, Phase II, and Phase III clinical data to generate CDISC compliant datasets.
• Responsible for various clinical data studies to create datasets and associated documents in a timely manner.
• Involved in writing, editing, validating, debugging code and developed new SAS programs and modified existing datasets using Set, Merge, Sort and ProcSql with various SAS functions.

Environment: SAS 9.3 version, SAS/BASE, SAS/MACRO, SQL, SAS/Connect, SAS/Share, MS-Office, WIN-NT, UNIX etc.

Confidential, Groton, CT

Data Analyst, Modeler, ETL Developer, SAS Developer

Responsibilities:

• Responsibilities: Being part of Business/Data analysis and includeGathered and documented business requirements and managed requirements.
• Involved in Data profiling, data cleansing, developing the extraction process of data from different sources using PL/SQL and SAS and performing transformations and finally loading the data into Oracle database for reporting.
• Acted as main POC for Users, Development and Testing teams for all the requirements related issues.
• Development of generic SAS programs for report generation.
• Created context diagrams, Business Process flows, Data flows, and required deliverables as per standards.

Environment: SAS 9 version, TOAD, SQL Navigator, SAS/BASE, SAS/MACRO, SQL, SAS/Connect, SAS/Share, Informatica 9.1, Oracle PL/SQL, MS-Office, WIN-NT etc.

Confidential, Groton, CT

Lead, SAS Programmer

Responsibilities:

• Worked on design, develop, testing and implementation of CDARS application which is web based system for analysis and reporting Phase I- Phase IV clinical trials.
• Design and develop standard SAS macros for generating standard Tables, Listings and Graphs (TLGs).
• Daily coordinating with Off-Shore team as well Business Sponsor and End Users.

Environment: SAS 9 version, Perl, TOAD, SQL Navigator, SAS AF/SCL, SAS/BASE, SAS/MACRO, SQL, SAS/Connect, SAS/Share, Unix, MS-Office, WIN-NT etc.

Confidential, NY

Technical Lead, Analyst, SAS Developer

Responsibilities:

• Analysis, design and Architecture of existing and new functionalities of Confidential SAS based Datawarehousing system.
• Worked on design, develop, testing and implementation of Confidential application which is built completely on SAS.
• Coordinated UAT (User Acceptance Testing) created UAT Plan, Test Cases and UAT summary report as part of the standard Project deliverables documentation.
• Created RTM (Requirement Traceability Matrix) to associate Test Cases and requirements (UAT).
• Projects: Involves major/minor and support of SAS application.
• Extracting data from PowerMHS and other source systems and loading data into SAS Data warehouse. Enhancements or modifications of SAS programs to in corporate changes in line of businesses or new line of businesses.

Environment: SAS 9.1 (Base, Macro, SQL, ACCESS, Share, Connect), SQL Server, PowerMHS, Windows etc.