Duties Involved:• Facilitate communication between Gilead and vendors• Work with Vendor Outsourcing to manage SP and Biostatistics contracts• Work with vendors on vendor relationship issues• Work with statistical programming teams to define vendor oversight processes for multiple statistical programming functions• On occasion take SP Lead role for outsourced studies to support operations• Work with Vendor Outsource Contracts team to maintain, develop, and innovate contracting models• Work with manager to support the Latest Estimate (LE) for annual budgeting• Work with Finance to implement SP Le budget and to monitor and support budget alignment activities• Work with SP Leadership team to manage budget and ensure alignment with budget goals• Support Contingent Workforce Program (CWP)o Define FieldGlass (FG) work order structure and work with CWP team for implementationo Review monthly FG reports to ensure workers are assigned to appropriate managers and cost centerso Support on-boarding and off-boarding of contingent workers (CW)o Point of contact for CWP team• Support SP and Biostatistics compliance to Gilead Contingent Workforce Policy• Draft End-Client Letter re H-1B Beneficiary for Vendor Employees, move through approval, signature, and applying document security• Member of SP Leadership Team• Member of Operational Management Team for vendor relations management• Chair Functional Management Team meetings with vendors

Gilead: Associate Director Statistical Programming February 2016Gilead: Senior Manager Statistical Programming August 2013 – January 2016Duties involve resource management project management, vendor management and management of eNDA and sNDA materials. Provide programming and support for the Clinical Operations, Clinical Science, and the Data Management and Statistical departments in their efforts to produce quality data and reports for use in regulatory submissions to the FDA.Accountable for successful completion of all projects and studies within the Oncology Therapeutic Area (Oncology TA) including but not limited to regulatory filings and regulatory requests for information. Apply innovative thinking to the development of new programming procedures to improve efficiency and consistency across studies.Identify and lead strategic initiatives for the Oncology programming group.Demonstrate ability to work collaboratively with other functional areas and counterpart from other sites.Manages a team of statistical programmers.Oversees all programming activities within a therapeutic area or equivalent.Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across a therapeutic area or equivalent. Excellent verbal and written communication skills and interpersonal skillsHas understanding of the business beyond the functional area.Capable of recommending new operating procedures as appropriate and determining if the analysis infrastructure needs changes to improve efficiency and minimize errors.Has the proven ability to directly supervise personnel.

Duties involve resource management, infrastructure management, project management, vendor management and management of eNDA materials. Provide programming and support for the Clinical Group, the Data Management and Statistical departments in their efforts to produce quality data and reports for use in regulatory submissions to the FDA.• Promoted to Associate Director effective July 1, 2012• Lead programmer for Phase 1, Phase 2, and Phase 3 trials• Production of Patient Profiles for Independent Review Committee (IRC)• Development of datasets and documentation for use in Carfizomib Submission• Management of Resourceso Manage FTE programmerso Management of Contractorso Screening and interviewing of contractors and FTE employeeso Working with, vendors, HR, Legal, Finance, and IT to initiate contactor start-upo Generate new job descriptions for statistical programmers based on Radford Scaleo Budgeting of Resources• Management of Infrastructureo Work with IT to efficiently run SAS Servero Work with IT to scale SAS programming capabilitieso Review Vendor products and technology that will increase efficiencies and quality• Management of Projectso Work with cross functional Project Teams to complete project deliverables on-time and deliver a quality product.o Investigator Initiated Trials (IIT) – management of resources and timelineso Budgeting of Projects • Management of Vendors o Work with Legal/Contracts Group to setup Master Service Agreements and Work Orders o Work with vendors to workout project specifications, identify timelines and mange vendor in order to meet timelines and provide a quality product.• Management of eNDA Materialso Division of Scientific Investigations (DSI) Materialso Work with Regulatory Publishing to deliver dataset documentation and other electronic data needed for eNDA

Validation of analysis datasets and development programming using SAS.• Validation of analysis datasets using independent programming methodology.• Development of a SAS process to check adherence of clinical data to XenoPort Data Standards.• Development of a SAS ODS process to generate standard appended tables and listings in RTF format using proportional fonsts (eg. Ariel and Time New Roman) based on XenoPort defined standards.• Development of a an Excel table driven methodology to perform WebSTDM checks on STDM data using SAS.• Development of a macro process to facilitate the generation of Data Management Review Listings

Duties involve programming and support for the Clinical Group, the Data Management and Statistical departments in their efforts to produce quality data and reports for use in regulatory submissions to the FDA.• Serve as lead programmer for Phase I trial.• Manage programming teams assigned to complete clinical trials.• Prepare STDM and analysis datasets based on CDISC specifications, CVT Standards, and specifications defined by statistician in the Statistical Analysis Plan (SAP)..• Program Graphical displays using SAS based on specifications provided by Statistician in SAP and TLF specs.

Duties involved programming and support for the Clinical Group, the Development Group, the Regulatory Group, the Data Management and Statistical departments in their efforts to produce quality data and reports for use in regulatory submissions to the FDA.• Serve as lead programmer for 510K, PMA, and e-BLA submissions.• Manage programming teams assigned to complete clinical trials.• Validation support for other clinical trials.• Preparation of CRT datasets, Annotated CRFs, and Define.pdf documents for Item 11 of eBLA and for hardcopy submissions.• Work with Medical writing and consulting Statisticians to publish appended tables, listings, and graphs for inclusion in Clinical Study Reports included in Item 8 of e-BLA.• Development of SAS based tools for PDF conversion of clinical reports, internal backups of clinical data, scheduling of complete runs of SAS programs, and ODS processes for generation of Excel reports. • Generate Biometrics department guidelines and SOPs; work with members of Medical Writing, QA, Statisticians, Programmers, and Data Management personnel for review and approval of aforementioned documents.• Work with IT on implementation of new SAS server. Generate user requirements, IQ-OQ validation documents, and PQ documents. Work with members of QA, Statisticians, Programmers, and Data Management personnel for review and approval of aforementioned documents.• Clinical systems support in the review, specifications, validation, implementation, and on-going support for clinical systems in the Biometrics Department.• Support clinical teams in analysis and cleanup of clinical trial data.• Support other departments in ad-hoc analysis of clinical trial and QC data.• Support Clinical teams in development of work instructions for site.

Duties involved programming and support for both the Data Management and Statistical departments in their efforts to submit an NDA.• Preparation of transport datasets and data definition tables for the Item 11 of an NDA.• Preparation of integrated analysis files for ISE.• Documentation of process used to create Item 11 information.

Duties involved programming and technical support for multiple departments, programming for NDA, programming and management of an Events Review Committee, Lead Analyst, development and management of technological infrastructure, management of departmental software, development of departmental processes, development of company and departmental validation documents, practices, and standard operating procedures, application evaluation and integration of electronic reporting processes used for E-NDAs.• Development of analysis datasets, tables, listings, and graphs for neurological analysis of co-primary end point of phase III study based upon the SAP. • Development of analysis datasets, TLG, worksheets, and CRF for the assessment of a subject's neurologic status by an independent committee (End Point Review Committee) at study termination.• Management of monthly data package generation, validation, and documentation associated with the End Point Review Committee process.• Lead Analysis for phase I and phase II projects, responsible for the management of resources, timelines, and report generation.• Development and implementation of a work process to convert all study materials to PDF format.• Installation, configuration, validation, implementation, maintenance and support of the SAS software on PC and NT servers.• Member of committees responsible for development of departmental procedures and practices. Includes standard analysis file structure based on CDISC model, departmental directory structure, and all phases associated with the development and archiving of regulated submission materials.• Member of committees to develop corporate validation policy. Includes corporate policy, Master Validation Plan (MVP), and General Standard Operating Procedures (GSOPs).• Member of committees to develop departmental validation policy and documentation. Included departmental Quality Assurance Plan (SQAP), SOPs, and validation templates.

Duties involved the development and implementation of validation protocols, supporting statisticians in the generation, modification, and integration of SAS programs used for clinical analysis, and support of the applications development team. Projects included the following:• Modification of SAS programs used to generate study reports.• Develop SAS programs that generate SAS Analysis Datasets.• Develop SAS programs that generate study reports.• Integration of study programs and the Clinos programming environment. • Assist application developers in the design, modification, debugging, and validation of internally developed software.• Design and implementation of validation protocols needed to validate NT Servers, Vendor supplied software, internally developed software/tools, and study programs.• SAS/IntrNet installation on an NT Server.

Duties revolved around application development using the SAS System, Oracle, and the Web. Projects included the following:• Design and development of a customized GUI application, which helped to automate certain manual tasks performed by the company’s Payroll and Human Resource department. Application utilized SAS/AF, SAS/SCL, SAS/BASE, SAS/MACROS, SAS/DDE, MS EXCEL, and REPORT SMITH.• Development of a Time Tracking and Billing Application used internally for billing of a pharmaceutical client. Application utilized SAS/AF, SAS/SCL, SAS/BASE, SAS/ACCESS, TimeLogger, MS EXCEL and MS WORD.• Support the team responsible for the development of a GUI application commissioned by a major pharmaceutical company. Help the team leader develop SQL statements, which query the companies Oracle database via SAS/CONNECT.• System documentation, generate a data dictionary, and recommendations for system enhancements of a forecasting application used by a major mail order music company to forecast inventory needs. Project utilized SAS/BASE, MS WORD, and ADOBE ACROBAT READER, EXCHANGE, and DISTILLER.• Develop the Advanced Solution Group Intranet site and serve as webmaster following completion. Web site development utilized Microsoft FrontPage, HTML, JAVA, and PERL.• Team member involved in a COBOL to SAS Legacy Conversion project for a major medical insurance company. Duties involved the creation of SAS DATA STEP commands needed to read in the COBOL data stored as flat files into SAS Datasets. Project utilized SAS/BASE.• Perform quality assurance tests on a customized SAS application used by a major telecommunications company to determine customer values. Testing utilized SAS/BASE and SAS/CONNECT.