SUMMARY

• Certified SAS programmer with over 6 years of SAS programming experience providing statistical programming support for multiple clinical research projects in pharmaceutical and healthcare industries.
• Experienced and Sound knowledge of working with Health Claims Data.
• Knowledge of Medical codes i.e. ICD10, HCPCS, CPT and Medical Claims Processing systems.
• Experience with version 9: Base SAS, SAS/Macros, SAS/SQL, SAS/STAT, SAS/Access, SAS/GRAPH, SAS/STAT and SAS/ODS in Windows and UNIX.
• Conducting, documenting and reporting computer validation inspections in compliance with 21 CFR Part 11, data transmission and integrity check for the existing and in - house Clinical Trial Systems.
• 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).
• Created CRT’s (Case Report Tabulations) and annotating Case Report Form (CRF’s) using CDISC standards for submissions to the FDA. Used XML for data formatting that fits the FDA’s strategies for electronic submissions.
• Good working knowledge of data summarization such as demographics, adverse events, laboratory data, physical, ECG, Vital signs etc., and efficacy endpoint analysis.
• Hands-on experience in using SAS/ODS to generate different files including XML, RTF, MS Excel, PDF and HTML.
• Wrote CDISC standard dataset specifications and follow specifications to create SDTM version 3.1 and AdaM Version 2.0 datasets.
• Used SAS extensively to analyze clinical data from CRF’s, creating SAS data sets for the purpose of analysis and report writing for clinical trials (Pre-clinical through Phases IV), generating efficacy and safety reports, creating datasets and generating reports using PROC Tabulate, PROC Report, Data Null, SAS arrays, PROC SQL and Macros, and verified and documented programs.
• Generated ADAM specifications under the guidance of project statistician.
• Good Experience in understanding the PROTOCOLS and CDISC Process (SDTM and ADAM Models).
• Provide statistical programming expertise from Phase I to Phase IV therapeutic studies to conduct statistical analysis in order to confirm the safe dosing frequency, safety and efficacy.
• Worked on Data mapping from Existing Raw data to CDISC SDTM Standards, data mapping from SDTM to AdaM Domains.
• Expert in using PROC SQL, PROC REPORT, PROC ACCESS, PROC GPLOT, PROC GCHART, PROC FORMAT, PROC TABULATE, DATA MERGE, SORT to generate reports.

TECHNICAL SKILLS

Clinical Trials: Phases I, II, III &IV, NDA Submissions and FDA Approvals

SAS: SAS v8, v9.1, 9.2. Base SAS, SAS/Macro, SAS/Access, SAS/SQL, SAS/STAT, SAS/Connect, SAS/GRAPH.

Languages: C, C++, MS Visual Basic5.0/6.0, SQL

Database Platforms: Oracle 8/9/10g, PL/SQL, MS SQL Server, DB2, DB2/400 and MS Access

OS: UNIX, LINUX, IBM AS/400, MS Windows 95/98/NT/2000, SCO UNIX, Sun Solaris

Others: MS Office, UNIX shell scripting.

SAS Skills: Base SAS programming (Windows and UNIX) - Advanced, SAS/MICRO- Advanced, SAS/STAT- Advanced, SAS/GRAPH- Advanced, SAS/ACCESS- Advanced, SAS/ODS- Advanced, SAS SQL- Advanced, SAS/STAT procedures- Advanced Clinical Trials- Advanced FDA Regulations, ICH Guidelines and GCP Requirements- Advanced CRA- Intermediate

PROFESSIONAL EXPERIENCE

Confidential, Charlotte, NC

SAS developer

Responsibilities:

• Implemented waterfall method of Software Development Life Cycle (SDLC) methodology for design, development, and implementation and testing of various SAS modules.
• Performed Impact Analysis on various Enterprise Data Management related SAS programs.
• Designed Technical Specification Documents (TSD) for impacted SAS processes.
• Involved in Remediation/Development of multiple SAS Programs impacted by ICD10.
• Performed enhancements to PL/SQL packages/procedures.
• Hands on experience using Enterprise Guide, X-Win 32 2012, SAS 9.3 for LINUX and UNIX platforms to execute various SAS modules.
• Proficient in using PL/SQL, SQL Developer, Toad for Oracle/db2 tools to perform data analysis.
• Preparation of test data and verification of test results in QA/UAT environment.
• Involved in creating regulatory reports supporting Medicare and Medicaid plans for various states.
• Sound understanding of Industry standard diagnosis and procedures codes like HCPCS, CPT, and ICD9/ICD10.
• Worked with multiple IT stakeholders to understand the specific functionalities associated with each impacted process/application.
• Worked with numerous business departments and third party vendors to validate the remediated files/processes.

Confidential, Roseland, NJ

SAS developer

Responsibilities:

• 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.
• 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.
• Helped Statistician in creating graphs using G-Plot.
• Performed Data entry and conversions, data validation and corrections, uploading/ downloading data from/to a PC.
• Extensive use of PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC MIXED, PROC REPORT, PROC TABULATE.
• Tested and debugged against the test data.
• Used SAS for pre-processing data, data analysis, generating reports, statistical analysis, and graphs.
• Responsible for locating appropriate databases for projects.
• Responsible for implementing and monitoring clinical research trials, tracking study progress, and ensuring data integrity.