Experience

Hurley Consulting Associates Ltd.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Lead Programmer

  • Jan 2017 - Present

• Lead Programmer

  • Jan 2017 - Present



UBC - An Express Scripts Company

• Statistical Programmer

  • Aug 2012 - Jan 2017

  Provide SAS statistical programming support for Registry studies, Phase I,II and III clinical trials covering therapeutic areas of Oncology, CNS, Respiratory, and Inflammatory diseases. Provide SAS statistical programming support for Registry studies, Phase I,II and III clinical trials covering therapeutic areas of Oncology, CNS, Respiratory, and Inflammatory diseases.



PPD

• United States
• Research Services
• 700 & Above Employee

• Senior Programmer Analyst

  • Feb 2012 - Jul 2012



United BioSource Corporation, Blue Bell, PA

• Senior Clinical Programmer Analyst

  • Sep 2008 - Feb 2012

  • Prepare, write and maintain computer programs for production of databases, tables and appendices for Phase I, II and III clinical trials for FDA submission.• Validation and review of SAS programs according to CFR Part 11 • Prepare/review project documentation/memos for external client communications in conjunction with the Project Manager• Responsible for data transfers, including documentation and correspondence with external vendors• Review Case Report Forms and help in the design of databases • Review Statiscitcal Analysis Plans and provide feedback to the author(s)• Mentor less experienced programmers• Project management tasks in conjunction with the Project Manager• Contribute towards pharmicokinetic process improvement initiative• Act as technical consultant to other departments• Attend client meetings in conjunction with the Project Manager



Bristol-Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Principle Analyst

  • Sep 2001 - Sep 2008

  • Provided SAS programming support for phase II/III clinical trials within the following therapeutic areas; cardiovascular, immunology and virology • Wrote safety/efficacy analysis SAS data set specs based on clinical protocol, CRF, SAP, and data presentation plan requirements• Developed/implemented/validated SAS programs to create SAS data sets, patient summaries/listings for: Demography, Study Status, PEs, Vitals, ECG, Medical History, Risk Factors, Study Medication Exposure, Concomitant Meds, Serious/Non-serious AEs, Lab Abnormalities, Clinical Study Endpoints• Documented and maintained User Acceptance Test plan validation and software development lifecycle according to federal regulation 21 CFR part 11, Good Clinical Practices and International Conference on Harmonization guidance• Wrote Oracle PL/SQL procedures that apply the National Cancer Institute common toxicity criteria to assess clinical laboratory data abnormalities• Designed and Developed SAS programming guidelines and macro programs for Integrated Review (I-Review) software implementation• Wrote SAS code in support of the following reporting deliverables from study startup through to NDA submission; clinical site data queries and cleaning, treatment arm un-blinding, annual IND updates, Data Safety Monitoring Board, Interim Analysis and Clinical Study Reports



E.I. DuPont, Scientific Computing Division

• Senior Analyst

  • Sep 1996 - Sep 2001

  • Scientific database consultant and database administrator• Managed Oracle database instances under Sun Solaris and Windows NT operating systems and provided data modeling services• Administered user licenses, physical database structures, storage, design, security and licensing agreements• Performed usage forecasting and capacity planning, performance tuning and backup and recovery• SAS Programmer/Consultant provided customized data access and analysis solutions• Designed, Developed and Implemented SAS/AF object oriented application GUI interfaces• Wrote procedures in SAS SCL and MACRO languages which dynamically build and execute SAS data steps for data access and manipulation, and statistical procedure steps for analysis of dose response data. Analysis included linear regression and graphical displays of bioassay data• Developed Turnkey solution; including access to Excel, RS/1 and ODBC data sources, graphical presentation export to Microsoft Word and installation and setup through Visual Basic programming• Developed documentation for custom SAS software solution for Agricultural Products divisions; Herbicide, Fungicide and Insecticide• Instructed comparative bioassay analysis training course for Biologists