PROFESSIONAL SUMMARY:

• SAS Programmer with 6+ years of professional experience in Clinical Trial projects and SAS Programming in teh CROs, Healthcare and Pharmaceutical industries.
• Experience in analyzing and coordinating clinical data, generating detail summary reports and data validation using FDA regulation procedures.
• Extensively involved in clinical data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries and Graphs according to teh Standard Operating Procedures (SOPs).
• Good experience in SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, and SAS/ODS, SAS/QC, SAS/AF and SAS/ETS on Windows and UNIX environment.
• Proficient in Macro Facility, SAS Procedures, SAS formats, SAS functions, SAS statements, SAS Informats, Merging SAS Data sets, preparing data, producing reports, storing and managing data in SAS.
• Good in modifying existing SAS programs and creating new programs using SAS macro variables to improve ease and speed of modification as well as consistency of results.
• Working with large volume data warehouses and data access tools (Windows, UNIX, etc.).
• Validating, testing, debugging SAS code to determine quality, completeness, and accuracy per specifications.
• Creating appropriate (business/technical) documentation for all teh programs developed.
• Exposed to health claim coding systems.
• Analyzed data sources for integrity, precision, and accuracy.
• Proficient in working with different clinical trials data like Demographic, Adverse Events (AE), Laboratory, Vital Signs etc.
• Involved in teh process of generating TLG’s (Tables, Listings and Graphs) for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
• Proven skills in data cleaning, data archival, data migration, ad - hoc reporting and coding using SAS on various environments.
• Good in performing CRF - Annotation with respect to various database designs.
• Experience in Compliance Reports including IND submissions and NDA Documentation, developed as per QC/QA protocols and FDA guidelines.
• Knowledge in conducting, documenting and reporting computer validation inspections in compliance with 21CFR Part 11 (21 Code of Federal Regulations) for clinical trial systems.
• Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM), Operational Data Model (ODM) and Case Report Tabulation Data Definition Specification (Define.xml).
• Has excellent analytical, problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels of teh organization and contributing to project success in multi-tasking, fast paced environment.

TECHNICAL SKILLS:

SAS TOOLS: SAS9., SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/SQL, SAS/QC

SAS PROCEDURES: SORT, CONTENTS,TRANSPOSE,GPLOT, GCHART, FREQ, MEANS, SQL, REPORT, TABULATE, PRINT, PRINTTO, GLM, SUMMARY, REG, CORR, UNIVARIATE, CDISC,LIFETEST, PHREG

Programming: SQL,RDBMS

Operating system: Windows98/2000/XP, Unix

Database: MS Access, SQL Server 7.0,oracle 9i

PROFESSIONAL EXPERIENCE

Confidential

Sr.SAS Clinical Programmer

Responsibilities:

• Extracted data from flat files, MS Excel, and Oracle Clinical database, created SAS data sets using different SAS procedures and SAS/SQL “Pass through facility”.
• Prepared new datasets from raw data files using import techniques and modified existing datasets using Set, Merge, and Sort, Update and other procedures and functions.
• Created clinical data tables like demography summary tables, Adverse TEMPEffects (AE), Serious Adverse TEMPEffects (SAE), Quality of Life (QOL) tables.
• Developed, validated and documented programs to create TLG’s (Tables, Listings and Graphs) as per Statistical Analysis Plan (SAP) using SAS reporting procedures like PROC REPORT, PROC TABULATE, graphic procedures like PROC GPLOT, PROC LIFETEST and analysis procedures like PROC MEANS, PROC UNIVARIATE and PROC FREQ.
• Developed and used SAS Macros programs to generate reports, tables and listings for clinical and bio-statistical review.
• Performed CRF-Annotation with respect to SAS variable names to aid programming.
• Generated Ad-Hoc reports for further analysis using SAS tools.
• Created SAS reports using teh Data Null technique and PROC REPORT for NDA submission as per FDA regulations and company standards.
• Used PROC COMPARE to conduct quality control checks on files, tables and listing.
• Created transport files for FDA submissions.
• Developed HTML, RTF and PDF reports using SAS ODS.

Environment: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH, SAS/ACCESS, SAS/STAT, SAS/CONNECT, Excel, Access, Oracle Clinical, SQL, PL/SQL, UNIX and Windows XP.

Confidential, Northbrook, Illinois

Sr. SAS Application Developer

Responsibilities:

• Worked extensively with business users on requirements gathering, analysis and documentation.
• Used SAS (Base SAS, Data Step, and PROC SQL) and SAS macro language with processing files of at least 5 million records of healthcare claims data.
• Extracted claims data from various databases like Oracle, DB2, SQL server, etc. using SQL Pass through Facility.
• Provided insight to teh sales/retail organization as to appropriate sales strategies and tactics using information and research findings.
• Identified growth opportunities to increase reach and circulation.
• Provided demographic analysis of telemarketing campaigns using Unix SAS for call list target market and call center TEMPeffectiveness determinations.
• Worked on data cleaning, merging data from multiple files (e.g. medical, pharmacy), applying project-specific inclusion/exclusion criteria, coding project-specific variables and producing participant/member-level datasets.
• Designed and tested prescription, over teh counter and retail evaluation programs/mailings.

Environment: BASE SAS, SAS/MACROS, SAS SQL, SAS/STAT, SAS/GRAPH, SAS ODS, SAS/ACCESS, SAS/CONNECT, SAS EG, Windows and UNIX.

Confidential, NJ

SAS Programmer (Clinical)

Responsibilities:

• Coordinate with clinical data management team and generated safety and efficacy tables (demography, pharmacokinetics, vital signs, and lab).
• Based on teh SAP, manipulated different variables in teh datasets.
• Used different statistical procedures to bring up an inference on different occasions.
• Develop MACROS for various routines depending upon teh necessity.
• Support for monitor and quality assurance of data from clinical trials.
• Computed ad-hoc reports for various statisticians’ requirements.
• Studied teh protocol and CRF validate teh data and check for data entry errors.
• Involved in teh development of flow charts for teh SAS programs with teh details of SAS datasets used and how they were used and worked accordingly.
• Developed close working relationships with other members of teh Statistics team.
• Review teh protocol, case report forms (CRFs), statistical analysis plan (SAP) for Clinical trials.

Environment: SAS 8.2, SAS/MACROS, SAS/SQL, SAS/Graph, Oracle 9, PL/SQL, SAS/STAT, Oracle Clinical, MS Office, UNIX and Windows NT.

Confidential

SAS Programmer

Responsibilities:

• Analyzed three phases (me-III) of teh Clinical Trials in different therapeutics areas.
• Developed SAS programs using SAS/BASE, SAS/SQL, SAS/MACROS, SAS/STAT and SAS/GRAPH and for statistical analysis and data displays.
• Experience with creating all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE.
• Contributed to ongoing preparation of SAS datasets for statistical analyses and demonstrations.
• Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.
• In-depth noledge of programming and reporting with Base SAS, SAS/STAT, SAS Language, SAS/ODS and Graph.
• Macros were written at various instances for automating listings and graphing of clinical data for analysis.
• Participated in edit check program development, testing and implementation when required by in house data management system.
• Generate reports either in HTML, PDF or RTF formats according to teh client specifications.

Environment: SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, Oracle, Windows.

SAS Trainee/Programmer

Responsibilities:

• Experience in utilizing SAS Procedures and other SAS applications for data updates, data cleansing and reporting.
• Identify and correct data step syntax and programming logic errors.
• Efficient in using data step programming to solve complex programs.
• Experienced inImportandExportof clinical data across a variety of applications to and from SAS.
• Experienced in validation of programs and processes to extract data from Clinical data management systems, to prepare data listings, summary tables and reports using SAS.
• Provided data verification and problem resolution as and when required.
• Proficient inSAS/BASE, SAS/ODS, SAS/SQLand experience in producing external files and reports employing various SAS procedures likePROCPRINT, PROC REPORT, PROC SUMMARY.
• UsedSASdata step functions, formats, statements and procedures like PROC FORMAT and to map teh variables to teh customer’s needs. Involved in writing code using BASESASandSAS/Macros to extract clean and validate data from oracle tables.

Environment:SASV8, SAS/BASE, SAS/SQL, SAS/ODS, Windows 98, Excel/Access 2000.