At Catalyst, we are laser-focused on advancing clinical development programs with the provision of flexible, fit-for-purpose solutions that meet our customer’s unique needs and distinct study requirements:* Global Resourcing (from one person to an entire team)* Functional Service Provider (clinical, biometrics and safety/medical)* Full Service Managed Studies (with a focus on oncology therapeutics) As our depth and breadth of our functional and geographic reach has broadened, we continue to hold true to our core tenets by which we’ve been known: Integrity, Transparency, Flexibility, Responsiveness and Customer Service.

Responsibilities included systems development of Gilead bespoke CDISC metadata systems. Building Version 2 Define XML/HTML files using Gilead CDISC standards and using SAS's Clinical Standards Toolkit (CST)macros. Wrote system to convert Gilead's Version 1 Define files to Version 2 Define files using CST macros. Creating metadata data sets/ Excel files for Pinnacle 21 Enterprise consumption to create and validate version 2 Define file creation. Worked with the Data Standards (DS) to create bespoke set of CDISC checks of their published CDISC SDTM/ADaM standards.Also worked with Data Standards to generate a SDTM study based metadata repository collecting data from a large number of Gilead’s study specific specifications. Developed tools to generate CDISC metadata and report the comparison of a study’s specific SDTM standards with Gilead’s published standards. Developed CDISC utilities and reports to work with SDTM SAS logs, SDTM define files (version 1 and 2), and auto-generation of individual SDTM domain programs based on a study’s specific SDTM specifications file. Built a web based “dashboard” set of reports providing quick access to points of interest in the metadata repository.

Similar role as GSK work

Project manager for GSK’s OpenCDISC Validator (OCV) implementation and support including delivery to the Linux validated environment, training and demos. Developed integration of GSK’s SDTM standards and GSK’s coded terminology (extensible and sponsor). Additionally, perform quarterly updates of CDISC CT. Worked with GSK’s Data Standards in the development of a “GSK version” of the SDTM interpreted rules and GSK enhanced coded terminology OCV metadata files. Answered user questions from OCV reports using OCV’s forum (Pinnacle 21).Developed an Excel “SDTM Study Specifications” report using SAS and GSK’s SDTM metadata repository DB for purposes of transforming studies started with GSK’s internal standards (IDSL) to SDTM study standards. Report outlines IDSL study datasets/variables, transformation steps to the study’s SDTM domains/variables, incl GSK bespoke domains for study specific and therapeutic domainsDeveloped clinical reference data/dictionaries system used with IDSL studies and SDTM study conversions at GSK. Data includes: clinical trials SAS format catalog, GSK Drug, MedDRA, etc. Involved with the creation of new reference data repository database in the role of database developer. Responsible for the data migration scripts to new repository, package procedures development, and database enhancements.Responsible for creating transfer utility of global data to GSK’s SDTM conversion partner Accenture’s sFTP site.Created and support the TRANUTIL utility used by GSK’s Data Management leads. Used to package IDSL clinical trials data, study specifications, code / decode lists sent to/from CROsDatabase administrator for Mapping Specification Application (MSA) system which governed the rule sets for converting between GSK’s IDSL standard and CDISC. Developed all Oracle packages for user interface and maintained themResponsible for Oracle database development migrate global and study specific data to new unique database schema and read-only user access

IT Technical Lead for the NOAEL project. Responsibilities for this project including taking the vendor proposed system through approval process including the GSK's Gate 2 committee and technical assessment for the integration of the proposed system into the GSK computing environment.Technical IT lead for Safety SAS macros. Responsibilities included delivery of multiple macros using out sourced resources. Additional responsibilities were for the unit specification documentation, source code review, and macro unit test case documentation, testing and test results.Developed GSK's ETL SAS Spectre system. Data Management system that used a multi-tab web based UI to extracted Oracle ClinTrial raw data and transformed into GSK's IDSL (internal) standards. Wrote code to loaded and validated incoming CRO data (CSV, XPT files) reporting load results to study team via emails. Also programmed the system's data cleaning tests, generating 14 different RTF reports sent to study teams via email system. UNIX based system was developed to "wake up"​, look for scheduled jobs, execute all outstanding jobs, reporting results to study team and save job results in an Oracle schema accessible by the UI. System was built to handle any unexpected SAS errors by creating individual sub task SAS jobs and capturing that job's status results. Developed test cases, lined up user testers, and handle all problems found during validation testing for this system. Responsible for version control of code, documentation, and change requests in a validated environment.Project leader for the World Wide Epidemiology (Epi) department’s computer systems including management of project team and their resource requirements/allocations. Responsibilities include project leader for development and implementation of system that used the UK Outcomes Research General Practice Research Database (GPRD) System project and NCHS database system.

Member of Information Services providing end-user applications and support. Provided automated Quality Control charts, tables, and reports for all BASF laboratories, distributed ad-hoc data analysis applications linking Oracle databases with VAX-based statistical routines. In addition, end-user support and training was provided across the division, as required.

Responsible for designing and developing a multinodal network system simulation model including post-processing of model-generated databases under VAX/VMS using Fortran, SAS, and Disspla. Determined design requirements of a database system, received commendation award from client. Contributed to a national exercise as a data manager. Participated in software development for the Joint Maritime Information Element project. Developed forms and message generation software using C, Pascal, and dBase III plus. (Top Secret / SBI clearance required)