POSITION

Programmer/Analyst for systems developed using SAS. Specialties include in-house monthly SAS Technical bulletin; building utilities for the standardization of aspects such as LOG checkers, combining documents and macros to simplify basic continuous, categorical and occurrence statistics; developing and generating the CRT section of an E-Sub (NDA) to regulatory agencies; building Data Analysis datasets (including CDISC SDTM and ADaM datasets); and Reporting and Data Management applications independent of operating system.

OVERVIEW

David has been developing SAS applications since 1986, and since 1990 mainly pharmaceutical clients using micro and mini computer platforms. His task assignments include: Assisting in developing standard procedures and utilities to create common development tools (this included introducing a in-house product to the team gain significant saving in development and maintainability of programs); Running an in-house SAS Technical bulletin; Generating E-Subs (NDAs) for Regulatory Review; Analysis and Reporting; Analysis and Reporting; Creation of CDISC SDTM and ADaM datasets from raw eCRF/CRF datasets; Specialist development, including in-house CRT, Narrative Header generator, and CDISC/Warehouse applications; and Data Validation and Clinical Data Management.

PUBLISHED

Numerous papers at various national, regional and local events since 1997 including, but not limited to: PharmaSUG 2021 titled "Mashing Two Datasets Together", "Thwarting Nasties" and "Generating the Demographics and Adverse Event Tables Using Excel and VBA".

SAS PROJECTS

February 2021 - Present, Everest Clinical Research, Little Falls, NJ, USA
Title: Principal Statisticial Programmmer
Lead, Primary and QC SAS Programmer in numerous studies working on tasks not limited to ADaM specification design; ADaM analysis datasets, tables, listings and figures for safety and efficacy analysis. Additionally involved in beta-testing new login and programming environment with a customer and working with a team developing graphic (figures) output standards and templates.

August 2013 - January 2021, IQVIA (formally Quintiles Outcome), Cambridge, MA, USA
Primary and QC SAS Programmer, mainly building derived analysis datasets, tables, listings and figures for safety and efficacy analysis on a number of studies that were in trouble with timelines and had quality issues. Also assisted in answering adhoc requests where required. Started an internal SAS User Group monthly newsletter that went out around the company with SAS related articles that are of interest, and proposed action plans, including a mentoring program, to improve quality. Was part of team leading standardization of processes and creating tools for enhancement of work practices, including tools and macros to check SAS LOGs, combining TLFs, macros for generating output for standard TLFs, macros for calculating statistics if a standard form for easy maintainability, and bringing to the group an in-house programming environment for producing output in a standard form with the ability to bring sections of code from one study to another.

December 1991 - August 2013, Consultant
Primary or QC SAS Programmer for reporting of numerous clinical studies (tables, listings and figures as well as adhoc requests from Clinicians, FDA, etc.) to requested specifications; developed multiple ISS databases and reported in the form of tables and figures for clinical submission to regulatory authorities; writing text for the CRT section of many successful regulatory submissions; and Annual Reports to the FDA. Output has been ODS LISTING, ODS PDF and ODS RTF. Developed many applications that included generation of the CRT section of an E-Sub (NDA) to regulatory agencies (included PDF links and bookmarks to required standards - replaced an off-the-shelf application); development of programs that generate Patient Narratives; solutions of adding text for PDF bookmarks in ODS RTF generated tables, listings and figures so output can go directly into MDoc; and applications that included generation of Dynamic Listings of the data for review (has the facility for the reviewer to subset the listings at the patient level - this uses SAS to generate the Excel application and workbook with VBA macros, and the reviewers use this Excel workbook to review the data replaced paper By Patient Listings). Mentored junior and senior programmers and gave numerous technical talks on topics including SAS (e.g. how to, and how SAS calculates various statistics), Word/Excel (usage and VBA related) and DOS (batch programming). Worked on teams developing a standards for CDISC SDTM and ADaM structures, and worked on number of studies where the data was converted from raw study datasets to SDTM datasets, and then SDTM datasets to ADaM datasets for analysis. Recognized a number of times for high-impact contribution to clients. Companies have included (abreviated) ArQule, Woburn, MA, USA; Novartis Vaccines, Cambridge, MA, USA; Millennium Pharmaceuticals, Cambridge, MA, USA; H. Lundbeck A/S, Copenhagen, Denmark; Pfizer, Kent, UK.