Data Analyst Clinical Trials
Resume:
John R Gerlach, B.A.
SAS / CDISC Analyst
*************@*****.***
EDUCATION
University of Texas at Austin
Austin, TX
**** ********: Chinese Mandarin, Italian
Defense Language Institute
Monterey, CA
PROFESSIONAL EXPERIENCE
Oct 2012 to Present SAS / CDISC Analyst
Rinascimento, LLC
Raleigh, NC
• Clients: Currently, Navitas Life Sciences (Sanofi) CSG; Planet Pharma; Syneoshealth, Merck, UCB, BMS
Work on numerous clinical trials across many therapeutic areas for client pharmaceutical companies.
Create and validate SDTM domains and ADaM data sets.
Develop applications for creating and validating SDTM domains.
Generate and validate Tables, Listings, and Figures for Phases I-IV, and ISS studies.
Re-engineer a Data Checks application for large patient registries.
Write SAS macros to facilitate clinical programming.
Develop SAS application to simulate a Phase III cardiovascular study for Adaptive Clinical Trials.
Write and review specifications for projects.
Implement creative, well-documented solutions intended to enhance and standardize existing processes using a deep knowledge of the SAS Macro Language, as well as XML and SQL.
Oct 2011 to Oct 2012 SAS / CDISC Analyst
TAKE Solutions, Inc.
Princeton, NJ
Re-engineered SAS application for CDISC conversion projects
Wrote macros to facilitate CDISC implementation.
Wrote White Papers on SAS and CDISC.
Mar 2007 to Oct 2011 SAS Analyst / Developer & Project Manager MaxisIT, Inc.
Edison, NJ
Subject Matter Expert on SAS, CDISC, and OpenCDISC.
Managed SAS application projects and CDISC conversion projects.
Wrote a SAS application for validating SDTM domains.
Wrote a SAS application for generating the Case Report Tabulation Data Definition Specificaiton (CRT-DDS) document (Define-XML).
Wrote white papers on SAS and CDISC.
Apr 2004 to Mar 2007 SAS Data Analyst
JRG Consulting, LLC
Hamilton, NJ
Developed SAS applications at various companies for the pharmaceutical and finance industries.
Wrote and presented SAS papers.
Taught SAS.
Oct 2003 to Apr 2004 SAS Data Analyst
Aetna Insurance
Blue Bell, PA
Implemented marketing / statistical methodologies using claims data doing patient-level longitudinal analysis for the pharmaceutical industry. Jan 2003 to Sep 2003 SAS Clinical Programmer
PRA International
Horsham, PA
Worked on several large clinical trials involving cardiovascular and gastroenterology studies.
Produced custom reports for the DSMB.
Generated analysis data sets for reporting.
Performed validation.
Apr 2001 to Jan 2003 SAS Data Analyst
NDC Health
Yardley, PA
Developed new applications and re-designed existing applications related to patient-level studies.
Developed methodologies for new products and services. Oct 2003 to Apr 2004 SAS Data Analyst
IMS Health
Blue Bell, PA
Led successful initiative to reverse-engineer a Risk Analysis system consisting of over 30,000 lines of SAS code. Re-designed and implemented a new system consisting of 10,000 lines of code, quadrupling its functionality.
ADDITIONAL INFORMATION
• Self-motivated thinker able to provide and explain creative solutions, always having a
‘Can-do’ attitude.
• Author of over 45 papers presented at SAS, PhUSE, CDISC conferences.
• Won Best Paper Award at the SAS Global Forum Conference, 2012: A Standard SAS Program for Corroborating OpenCDISC Error Messages.
• Paper, Solving Kenken Puzzles -- By Not Playing, published in the semi-annual PhUSE journal, "Pharmaceutical Programming" December, 2010
• Invited paper at the first SAS Global Forum Conference, 2007: Sudoku Puzzles -- Using a Cube to Solve the Square.
• Won Best Paper Award at the SUGI 24 Conference, 1999: User-Specified Text Flow Inside the Report Procedure.
• Clinical Trial Experience (Therapeutic Areas)
o Cardiovascular, Gastroenterology, Oncology, Endocrinology.
• Veteran, US Air Force.
PUBLICATIONS / PRESENTATIONS (Partial List)
• The Knight’s Tour in 3-Dimensional Chess.
Invited paper, SAS Global Forum 2019. PharmaSUG and SESUG 2019.
• Patient-Level Longitudinal Analysis Plots Showing Adverse Event Timelines and Dose Titration Levels.
PharmaSUG, SCSUG, and SESUG 2018.
• Generating Homeomorphically Irreducible Trees (Solving the Blackboard Problem in the Movie “Good Will Hunting”).
PharmaSUG 2017.
• Creating Viable SAS Data Sets from Survey Monkey Transport Files. WUSS, SESUG 2016.
• The Knight’s Tour in Chess – Implementing a Heuristic Solution. SAS Global Forum, PharmaSUG, WUSS, and Analytics 2015.
• Statistical Analyses across Overlapping Time Intervals Based on Person Years PharmaSUG 2015.
• Common and Comparative Incidence Indicators of Adverse Events for Well-Defined Study Pools.
PharmaSUG 2014.
• Imputing Dose Levels for Adverse Events.
• Solving Samurai Sudoku Puzzles – A First Attempt. PharmaSUG 2013.
• A Standard SAS Program for Corroborating OpenCDISC Error Messages.
• Generating SUPPQUAL Domains from SDTM Domains.
SAS Global Forum 2012. (First paper won Best Paper award).
• Resolving OpenCDISC Error Messages Using SAS.
PharmaSUG 2011.
• Validating Controlled Terminology in SDTM Domains. CDISC Interchange 2011.
• Facilitating Data Integration for Regulatory Submissions. SESUG 2010.
• Solving Kenken Puzzles – By Not Playing.
PhUSE 2010.
• A Relational Understanding of the BRIDG Model and the Roadmap to Achieve a Semantically Interoperable System.
CDISC Interchange 2009.
• A Programming Methodology for Creating CDISC Domains. SESUG 2008.
• A Scalable Platform for Clinical Trials – Interoperability and Automation in a Web-Based Environment.
Invited paper for PharmaSUG 2007.
• SAS and Sudoku – A Roundtable Discussion.
SAS Global Forum 2007.
• Sudoku Puzzles – Using a Cube to Solve the Square.
• A Relational Understanding of SDTM Tables.
SESUG 2006.
• Imputing ISO8601 Dates From Character Variables Containing Partial Dates. PharmaSUG 2006.
• A Better Perspective of SASHELP Views.
• Validating Data Using SAS Formats as a Programming Tool. PharmaSUG 2005.
• Generating N-Shell Programs for N-Reports in a Clinical Trial. PharmaSUG 2004.
• A Partitioning Method for Processing Large Data Files.
• Maintaining and Assigning Rates Dependent on Two Quantitative Variables. NESUG 2003.
• Selecting Balanced Cohorts for Comparison in Observational Research. PharmaSUG 2003.
• The Heuristic Program.
• Splitting Large Data Files.
SUGI 2002.
• A Meta-Data Approach to Problem Solving.
SUGI 2001.
• A SAS Software Toolkit for Reverse Engineering Large Projects.
• Creating Meta-Data to Solve a Problem.
NESUG 2000.
• Those Missing Values in Questionnaires.
• A Cross-reference for SAS Data Libraries.
SESUG 1999.
• User-Specified Text Flow Inside the Report Procedure. SUGI 1999. Won Best Paper Award.
• Formats As A Programming Tool.
Invited paper for SESUG 1998.
• Creating Numeric Formats Based on Precision, Not Magnitude.
• A Comprehensive Codebook Generator.
SUGI 1998.
• Validating Data Using a Format Library.
• The Six Ampersand Solution.
NESUG 1997.
• A Codebook Generator for the SAS System.
Invited paper for SUGI 1994.
• Macro Quoting Resolved.
SESUG 1993.
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