Career Portfolio provided by Beyond.com

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1 Career Portfolio provided by Beyond.com Senior SAS Programmer Coventry, RI Member Number: Portfolio: Professional Information Job Function: Science & Biotech, Healthcare & Medical, Information Technology Education: 4-Year College Degree Experience: 21+ Years Employment: Any Position Type, 1099 Contractor, W-2 Contractor Salary: $ k Security Clearance: None Citizenship: U.S. Citizen Resume QUALIFICATION SUMMARY Over twenty years of IT and management experience as a Customer Engagement Manager, Technical Team Lead, and SAS Software Developer within the Pharmaceutical Industry and Public Health with a proven track record of delivery and customer service. I am currently seeking opportunities that can leverage my knowledge of the Pharmaceutical Industry and experience in Clinical Regulatory Reporting and SAS Programming. &#***; *** years programming in SAS &#***; Generic code development that can be applied across clinical trial designs &#***; Parameter and data driven macro procedures &#***; Familiar working with Oracle Clinical Tables, Views and RXA_DES meta-data files &#***; Over *** years of processing clinical data using Pfizer Data Standards which is based on the CDISC/STDM Industry Standard &#***; Clinical Medical Dictionaries: MedDRA, ICD9, Whodrug &#***; Developed applications and reporting system that are *** CFR Part *** compliant &#***; Regulatory reporting of Clinical Safety and Protocol Registry data &#***; Clinical AR, CSR, IB, NDA Reporting Types &#***; Integrated Summary of Safety (ISS) &#***; Enterprise Life Cycle Experience &#***; Customer Engagement Manager / Technical Team Lead / People Manager

2 CLINICAL DATA EXPERIENCE: &#***; Inclusion/Exclusion &#***; Adverse Events &#***; Demographics &#***; Drug Treatment &#***; Subject Summary &#***; Primary Diagnosis &#***; Concomitant Medications &#***; Medical History &#***; ECG &#***; Vitals &#***; Laboratory &#***; Protocol Registry &#***; MedDRA &#***; ICD9 &#***; WHODRUG &#***; Pharmacogenomics &#***; Clinical Biomarker Data PROFESSIONAL EXPERIENCE Pfizer Inc., New London Connecticut (*** Present) Pfizer Inc Senior SAS Software Developer / Technical Lead supporting Clinical Data Visualization/Monitoring and Safety & Risk Management Regulatory Reporting (*** Present) Clinical Data Visualization utilizing SAS, Oracle, and Spotfire Developed repeatable extraction and optimized translation routines of Oracle Clinical Safety Data using SAS that enhances the ability to surface data to clinical project teams through the use of Tibco Spotfire Data is managed within the Pfizer Data Standard which is based on the CDISC/SDTM Industry Standard with the exception of additional Safety and Efficacy measurements not currently supported out of CDISC Data is also reloaded back into Oracle tables allowing for the global access and visualization off of Spotfire Documented utilities and processes to ensure future support of process and procedures Responsible for the re-engineering and delivery of the Safety and Risk Management (SRM) Periodic Safety Update and Annual Study Reporting (PSUR/ASR) off of the newly deployed Oracle/Siebel Clinical Trial Relationship Management (CTRM) system. Business Analysis Documented business requirements including the virtual data model, clinical algorithms, and annotated tables and listings

3 Developed and implemented a technical assessment instrument which utilized a scale to determine feasibility and success criteria based on business requirements. Assessment included CTRM Analytics, Business Objects Universe, and SAS. The business and technical team agreed that SAS provided the greatest flexibility and confidence of success in developing the data acquisition and reporting software within the allotted time frame Developed a pilot of the reporting utilizing SAS within the Pfizer Clinical Data Analysis and Reporting System (CDARS) Gained cost estimate approval for new development and ongoing support Finalizing functional requirements and design which also includes a detailed physical data model, detailed algorithms, annotated tables and listings, and incremental filtering capabilities Currently developing validated SAS regulatory reporting software and providing oversight of testing to ensure software complies with Pfizer Software Development Lifecycle and Quality Assurance procedures Pfizer Inc Informatics Director Strategic Directory, Customer Engagement Manager, SAS Software Developer supporting Global Clinical Network, Global Statistic, Global Clinical Pharmacology, Molecular and Translational Medicine (*** ***) Developed IT product & service strategies and associated project investment proposals that enable the successful advancement of business strategies within assigned area of responsibility Co-chair of the business and informatics integrated progress team: &#***; Establish and maintain IT Strategy that aligns with Business Strategy &#***; Prioritize investments according to strategy &#***; Portfolio responsibility for New and Sustain IT projects &#***; Developed the Business and IT Governance Model to support the Strategic Initiative, Project Execution, and Operational Support Manage and mentor the professional growth of internal Customer Engagement Managers, Project Managers, Technical Team Leads and Developers Along with managing, I was also personally responsible for Customer Engagement, Project Management, and SAS Software Development in the delivery of IT solutions to my customers &#***; I saved Pfizer over $***K in annual support costs by leveraging SAS to reverse engineer the translational medicines clinical biomarker repository and metrics tool from a J2EE/Oracle application into SharePoint &#***; Managed the evaluation and deployment of Pfizer s first GCP validated Genologics LIMS solution in support of Pharmacogenomics Responsible for ensuring product and service value is achieved via effective uptake and change management. Responsible for a sustain and new development budget portfolio that exceeded $5M annually Nominated by my team for the Pfizer Management Award Pfizer Inc. - Clinical Analysis & Reporting: Strategic Director, Technical Team Lead, SAS Software Developer (*** ***) Clinical Data Analysis and Reporting System (CDARS) is a web based application that manages all of the regulatory clinical reporting requirements at Pfizer within a *** CFR Part *** compliant environment. It was first deployed in *** and is still the primary reporting environment at Pfizer today. I was responsible for managing the development and support of the user interface, all clinical reporting software development, along with the strategic planning and tactical implementation of the application from *** to ***

4 Responsibilities included: In-depth understanding of internal and industry clinical data standards (CDISC), clinical trial reporting processes and regulatory requirements Provided direction and mentoring to the team and incorporated innovative approaches to the development of generic clinical reporting software Reporting software is maintained at the system level and parameter and data driven techniques are used to accommodate the variation in clinical algorithms based on clinical study design Parameter driven sub-setting and by variable processing Ability to manually remap treatment labels for specific reporting purposes Ability to generated standard study level safety and efficacy reports along with Integrated Summary of Safety (ISS) and Efficacy (ISE) is built into all of the reporting software In addition to managing the development team, I was also the subject matter expert responsible for the development and support of all Adverse Events, Demographics, and Subject Final Summary reporting software Rhode Island Department of Health - Statistical Programmer/Systems Analyst, Cancer Registry (*** ***) Involved in the development of analytical tools used to analyze public health survey data Lead developer of the Rhode Island Cancer Registry and Vital Statistics Death Index Freelance Software Developer (*** ***) Provided statistical programming and database development services to physicians and scientists conducting outcome and behavioral research on patients at Rhode Island and Merriam Hospital; Hospitalization data for the Neonatal Research Center in Providence Rhode Island; Development of an inventory and distribution system for a company called Healthcare Automation Brown University - Statistical Programmer (*** ***) Provided statistical programming support using SAS, Spssx, and BMPS for principle investigators researching survey level data on oncology, neonatal, and gerontology studies Technical Skills: Office Productivity: Microsoft Office Suite Programming: SAS, SQL, Perl Collaboration Tools: Livelink, SharePoint, Mind Manager, Enterprise Architect Software Engineering Tools: Source Forge, CVS, Subversion, RCS Database / Tools: Oracle, PIMS, Quest Toad & SQL Navigator, Pipeline-Pilot Operating Systems: Solaris UNIX, Windows XP Visualization Tools: Spotfire Volunteer:

5 Member of the American Health Information Community - Personalized Healthcare Working Group (October *** January ***) Primarily focused on developing standards and nationally influencing legislation to manage personalized genetic information within national Electronic Medical Records (EMR) along with safe guarding patient confidentiality, privacy, and security URL: *** team achieved the Pfizer Colleague Recognition Award for their efforts in the development and support of the Clinical Data Analysis and Reporting System (CDARS) Recipient of the *** SAS Enterprise Award for the integration of robust repeatable SAS reporting modules within the CDARS Web-based application First individual recipient of the Pfizer Colleague Recognition Award for my support of Connecticut Drug Project Teams Nominated by my team for the Pfizer Manager Award Nominated by my customers for the work I led in the deployment of the first GCP compliant Pharmacogenomics LIMS system at Pfizer Nominated by my customers for the continuous improvement effort I led to ensure that visit schedule was consistently populated within our IVRS and Oracle Clinical Database leading to improved downstream integration of data within our Development Information Factory Education: Bachelor of Science, Biology, University of Massachusetts, Amherst, MA