SUMMARY SAS CDISC/SDTM Programmer Analyst with experience in the pharmaceutical industry in both Sponsors and CRO settings. Core strengths include: Up-to-date knowledge of FDA and ICH regulations and guidelines regarding electronic submissions eSubs Expertise in eSubs Support Services Knowledge of industry standards e. g. CDISC and up-to-date understanding of FDA submission requirements Expertise in technology for electronic submission Proficiency in generating TLGs, creating SAS datasets, updating macros, validating other programmers' output Therapeutic areas: Antiviral HIV, and Hepatitis C

TECHNICAL SKILLS PLATFORMS: Windows XP/2000/NT, and SUN/Solaris, UNIX LANGUAGES, OS SOFTWARE : SAS 9.3/9.2/8.2, SAS 6.12 on UNIX and Windows for Legacy Systems BASE SAS, Macros, SQL, ODS, GRAPH , SAS-JMP, SQL, SAS via Citrix with Exceed, Unix Shell Scripting, Sed Scripting, MS Office 2000, Excel, Access, Word, Project, PowerPoint TOOLS UTILITIES: UNIX/vi/emacs editors, Sql Plus, Sql Loader, Toad, SQL Navigator OTHER SOFTWARE TOOLS: SAS Clinical Standards Toolkit 'CST' v 1.2, v1.3, v1.4 for validation of CDISC/SDTM/AdAM datasets and Generating DEFINE.XML for FDA submissions

EXPERIENCE Confidential Statistical Programmer Validated listings, reports and value added level2 SAS datasets in support of HCV Hepatitis C projects. Participated in the QA and review of Tables and Listings 20 from Vendor for Interim Analysis. Ensured all validations of datasets and reports follow the SDLC process. Confidential Manager, Electronic Submission/Legacy/PDS/CDISC-SDTM Support SAS Programmer Provided Electronic Submission 'eSub' support to project teams and colleagues, supported the CDARS e-Sub process of PDS Pfizer Data Standards datasets for many key compounds Developed Pfizer's overall strategy with respect to how to resource the eSub work with project teams, and Pfizer's CDISC strategy and participation on the FDA/JANUS pilot project. Contributed and supported the mapping of Pfizer Data Standards PDS datatype domains into the CDISC/SDTM standard in collaboration with GCDS colleagues Implemented the new FDA requirements and guidelines for CDISC/SDTM submission Created and maintained documentation using the 'Pfizer-LiveLink' reference area for CDISC trainings materials to help educate pCRO and CPW POCs Participated at FDA-eData team with the e-Submission-group to research the issue of CDISC/SDTM large datasets size export files . Volunteered to test a study and achieved 65 improvement in size reduction of the transport files. New CDISC/FDA guidelines were communicated at the end of 2011 and became part of CDISC/SDTM 1.3 'Amendment Confidential Senior Analyst - SAS Programmer, Analyst - SAS Programmer, Supported the safety programming of several key Antiviral protocols and maintained the monthly safety edit checks reports Lead the safety and efficacy programming for several Antiviral studies, and produced all supplemental safety tables and appendices and the integrated studies Supported and delivered all Antiviral eSubs to the FDA Received many achievements awards for successful submission of several key compounds to FDA Confidential Statistical SAS Programmer II, Statistical SAS Programmer I, Clinical SAS Programmer, Assisted with the development of statistical tables for Phase II study report using the Pfizer Clinical Data Analysis and Reporting System CDARS . Contributed to the analysis of fraud detection using the Azithromycin Protocol 192 data. Developed graphical tools using SAS GRAPH, and Univariate and Multivariate techniques to detect sites with odd data situations, which could lead to further investigation, possibly fraud related. Produced data mapping routines to transform Kendle database into Client required formats. Processed data from sponsors, including data transfer, data cleaning, computer file management, reporting and documentation. Confidential SAS Programmer Conducted statistical programming, generated Clinical Trial Report CRT tables, Data Listings and Appendices, Data Analysis Reporting, Implementation, support and consulting. Participated in the eSub Process Development and Implementation, scanning, document conversion to PDF for publishing. Created SAS edit checks programs to ensure that the data collected by the investigators on the Case Report Forms CRF are within acceptable range. CLINICAL TRAINING CDISC's Training: CDISC SDTM v1.3 and SDTMIG v3.1.3, Octagon Now Part of Accenture, March 2013 CDISC The Analysis Data Model ADaM ADaM v2.1 and ADaMIG v1.0, Octagon March 2013 CDISC/SDTM SAS-Toolkit Workshop organized by d-Wise Technologies, Pfizer - Groton, CT January 2012 Clinical Data Interchange Standards Consortium, Inc., CDISC , SDTM 3.1.2 Theory and Application, CDISC - Baltimore, Maryland, November 2009 CDISC Legacy Data Conversion workshop, learned the methods and tools used to convert legacy data to one or more CDISC/SDTM standards, CDISC - Baltimore, Maryland, November 2009 SAS's Training: SAS Programming II: Manipulating Data with the Data Step, SAS Institute, June 2004 SQL Processing with the SAS System, SAS Institute, December 2003 SAS Macro Language: Advanced Topics, SAS Institute, November 2003 SAS Macro Language, Introduction, SAS Institute, September 2003 Kendle College's Training: Design and Analysis for PK/BE/PD Studies, Kendle In-house, April 2001 Imputation and Analysis of Missing Data, Kendle In-house, February 2001 Get-To-Know Clinical Quality Assurance CQA , Kendle In-house, January 2001 Introduction to Advanced Good Clinical Practices, Kendle College, November 2000 Introduction to Clinical Data Management 5.0 CEU , Kendle College, February 2000 Introduction to Clinical Trial Process 4.1 CEU , Kendle College, January 2000 PERFORMANCE AWARDS Pfizer's Awards: Successful completion of Bosutinib multiple submissions, October 2011 Successful completion of Apixaban CDISC/SDTM submission in a short time, study sponsored and submitted jointly with Bristol-Myers Squibb, December 2010 Awards In appreciation of the Entecavir resistance label electronic submission, December 2006 In appreciation of the collaboration and driving performance in achieving the database lock, December 2004 In appreciation of the support for the creation of the summary reports for the Atazanavir European Union EU Type II naive subject variation, July 2004 In appreciation of work performed to ensure a successful submission of the AI266-006 submission. April 2004 In appreciation of the exceptional results obtained from the production of tables and appendices in support of several key study reports for the Atazanavir NDA, December 2002 In appreciation of the exceptional results in preparing, in one afternoon for submission to FDA, an executive summary, supporting tables and electronic datasets for Atazanavir AI424045 Week 24 analysis, April 2002