PharmaSUG 2019 Interactive Schedule Grid

Welcome to the PharmaSUG 2019 Interactive Schedule Grid. Use the links below to jump to a portion of the schedule, then click on a paper title to view the abstract and other details!

(Revised June 12, 2019)

Monday AM Early

Monday AM Late

Monday PM Early

Monday PM Late

Tuesday AM Early

Tuesday AM Late

Tuesday PM Early

Tuesday PM Late

Wednesday AM Early

Wednesday AM Late



Monday AM Early

Section 8:00 AM 8:15 AM 8:30 AM 8:45 AM 9:00 AM 9:15 AM 9:30 AM 9:45 AM
Application Development Automate the Process to Ensure the Compliance with FDA Business Rules in SDTM Programming for FDA Submission Statistical application in Image Processing by Integrating C and SAS Learning SAS® GTL Basics with Practical Examples
Data Standards Using CDISC Standards with an MDR for EDC to Submission Traceability Streamlining the Metadata Management Process Using SAS® Life Science Analytics Framework Metadata Repository V1.0 - A Case Study in Standards Governance
Hands-on Training Developing Custom SAS Studio Tasks for Clinical Trial Graphs
Real World Evidence Stratified COX Regression: Five-year follow-up of attrition risk among HIV positive adults, Bamako Artificial Intelligence and Real World Evidence - it takes two to tango Real-world data as real-world evidence: Establishing the meaning of data as a prerequisite to determining secondary-use value
Reporting and Data Visualization Order, Order! Four Ways To Reorder Variables with SAS®, Ranked by Elegance and Efficiency. Back to the Future: Heckbert's Labeling Algorithm Applying an Experimental GTL Feature to CONSORT Diagrams Free Duplicates Here! Get Your Free Duplicates!
Strategic Implementation, Business Administration, Support Resources Avoiding Disaster: Manager's Guide on How to Rescue a Failing Outsourced Project Using freelancers in the programming world - Challenges and opportunities Vendor's Guide to Consistent, Reliable, and Timely CDISC Deliverables
Submission Standards Designing Flexible Data Standards Models The Anatomy of Clinical Trials Data: A Beginner's Guide

Monday AM Late

Section 10:00 AM 10:15 AM 10:30 AM 10:45 AM 11:00 AM 11:15 AM 11:30 AM 11:45 AM 12:00 PM
Application Development %LOGBINAUTO: A SAS 9.4 Macro for Automated Forward Selection of Log-Binomial Models Extending the umbrella of compliance: LSAF with R Distributed Computing An Application of Supervised Machine Learning Models on Natural Language Processing: Classifying QC Comments into Categories A SAS and VBScript cyborg to send emails effectively. Generating Color Coded Patient ID Spreadsheet (PID list) To Make It Easier for the Reviewers.
Data Standards Incremental Changes: ADaMIG v1.2 Update Updates on validation of ADaM data Pacemaker Guy: De-Mystifying a Business Use Case for SDTM Standard and Medical Device Domains Homogenizing Unique and Complex data into Standard SDTM Domains with TAUGs
Hands-on Training The Shape of SAS® Code
Posters Badge in Batch with Honeybadger: Generating Conference Badges with Quick Response (QR) Codes Containing Virtual Contact Cards (vCards) for Automatic Smart Phone Contact List Upload
Posters Raw data sets tracker: Time and project management based on the volume of available clinical data using SAS® software
Posters Using Pinnacle 21 Enterprise for define.xml Creation: Tips and Tricks from a CRO Perspective.
Posters In the Style Of David Letterman's "Top Ten" Lists, Our "Top Ten" PROC SQL Statements To Use in Your SAS Program
Posters Joining the SDTM and the SUPPxx Datasets
Posters A Macro to Expand Encrypted Zip Files on the SAS LSAF Environment
Real World Evidence Using Real-World Evidence to Affect the Opioid Crisis Innovative Technologies utilization in 21st Novel Clinical Research programs towards Generation of Real World Data. Patterns of risk factors and drug treatments among Hypertension patients Applications and Their Limitations of Real-World Data in Gene Therapy Trials
Reporting and Data Visualization An Innovative Efficacy Table Programming to Automate Its Figure Generation to Ensure Both High Quality and Efficiency With a Trace: Making Procedural Output and ODS Output Objects Work For You Heat Map and Map Chart using TIBCO Spotfire®
Strategic Implementation, Business Administration, Support Resources Embedded Processes - evolving face of QUALITY in the world of Robotic Process Automation (RPA). ISS Challenges and Solutions for a Compound with Multiple Submissions in Parallel Get to the Meat on Machine Learning Lessons Learned from Teaching 250+ Life Science Analytics (LSAF) Classes to Our Colleagues at Janssen Research and Development.
Submission Standards Clinical Development Standards for FDA Bioresearch Monitoring (BIMO) Submissions Sponsor Considerations for Building a Reviewer's Guide to Facilitate BIMO (Bioresearch Monitoring) Review Framework for German Dossier Submissions China NMPA (National Medical Products Administration) reform and new regulations/guidelines/requirements

Monday PM Early

Section 1:30 PM 1:45 PM 2:00 PM 2:15 PM 2:30 PM 2:45 PM 3:00 PM 3:15 PM
Advanced Programming One Macro to Produce Descriptive Statistic Summary Tables with P-Values Ensuring Programming Integrity with Python: Dynamic Code Plagiarism Detection Creating In-line Style Macro Functions Excel in SAS
Application Development ADME Study PK SDTM/ADaM And Graph A Simple SAS Utility to Combine Existing RTF Tables/Figures and Create a Multi-level Bookmark Hierarchy and a Hyperlinked TOC The Application of SAS-Excel Handshake in DDT Time Since Last Dose-Anatomy of a SQL Query
Data Standards What's New in the SDTMIG v3.3 and the SDTM v1.7 Forewarned is forearmed or how to deal with ADSL issues Leveraging Intermediate Data Sets to Achieve ADaM Traceability
Hands-on Training Interactive Graphs
Programming Techniques Programmatically mapping source variables to output SDTM variables based upon entries in a standard specifications Excel file Reducing the space requirements of SAS® data sets without sacrificing any variables or observations It's All About the Base-Procedures
Reporting and Data Visualization Effective Graphical Representation of Tumor Data How to Build a Complicated Patient Profile Graph by Using Graph Template Language: Turn Mystery to a LEGO Game Figure it out! Using significant figures from reported lab data to format TLF output Not That Dummy Data
Strategic Implementation, Business Administration, Support Resources Dataset Specifications: Recipes for Efficiency and Quality Integrating programming workflow into computing environments: A closer look SHIONOGI Global SAS System Renewal Project - How to Improve Statistical Programming Platform
Submission Standards Next Innovation in Pharma - CDISC data and Machine Learning An Automated, Metadata Approach to Electronic Dataset Submissions Exploring Common CDISC ADaM Conformance Findings A Practical Guide to the Issues Summary in the Data Conformance Summary of Reviewer's Guides

Monday PM Late

Section 3:30 PM 3:45 PM 4:00 PM 4:15 PM 4:30 PM 4:45 PM 5:00 PM 5:15 PM 5:30 PM
Advanced Programming Ushering SAS Emergency Medicine into the 21st Century: Toward Exception Handling Objectives, Actions, Outcomes, and Comms Where Is the Information We Are Looking For? Excel with MS Excel and X Commands: SAS® Programmers' Quick Tips Guide to Useful Advanced Excel Functions and X Commands. Automation of Review Process Quick Tips and Tricks: Perl Regular Expressions in SAS
Application Development Text Analysis of QC/Issue Tracker Using Natural Language Processing (NLP) Tools Automated Dynamic Data Exchange (DDE) Replacement Solution for SAS® GRID Auto-generation of Clinical Laboratory Unit Conversions Define-XML with ARM Creating a DOS Batch File to Run SAS® Programs
Data Standards 7 Habits of Highly Effective (Validation Issue) Managers Best Practices in Data Standards Governance More Traceability: Clarity in ADaM Metadata and Beyond
Future Forum Panel Discussion: Future Forum
Hands-on Training Integrating SAS and Microsoft Excel: Exploring the Many Options Available to You
Posters Advanced Project Management beyond Microsoft Project, Using PROC CPM, PROC GANTT, and Advanced Graphics
Posters A Practical SAS® Macro for Converting RTF to PDF Files
Posters Developing Analysis & Reporting Standards For Pharmaco-Epidemiology Observational Studies
Posters Put on the SAS® Sorting Hat and Discover Which Sort is Best for You!
Programming Techniques The Power of PROC FORMAT Proc Sort Revisited Performing Analytics on Free-Text Data Fields: A Programer's Wurst Nitemare
Reporting and Data Visualization The Power of Data Visualization in R Power Up Your Reporting Using the SAS® Output Delivery System
Strategic Implementation, Business Administration, Support Resources Begin with the End of Validation: Adapting QbD Approach in Statistical Programming to Achieve Quality and Compliance Excellence Throw Away the Key: Blockchain-ed Healthcare Data Don't Just Rely on Processes; Support Local Subject Matter Expertise Sponsor oversight: Proof is in the documents
Submission Standards Practical Guidance for ADaM Dataset Specifications and Define.xml Progression-Free Survival (PFS) Analysis in Solid Tumor Clinical Studies Enforcing Standards in an Organization: A Practical 6 Step-Approach

Tuesday AM Early

Section 8:00 AM 8:15 AM 8:30 AM 8:45 AM 9:00 AM 9:15 AM 9:30 AM 9:45 AM
Advanced Programming Auto-Annotate Case Report Forms with SAS® and SAS XML Mapper PROC SORT (then and) NOW The Art of Defensive Programming: Coping with Unseen Data
Application Development Automate the Mundane: Using Python for Text Mining Why we should learn Python Create Interactive Data Visualizations for Clinical Data Review Using Base SAS® and Javascript
Data Standards Timing is Everything: Defining ADaM Period, Subperiod and Phase Raising the Bar: CDASH implementation in a biometrics CRO Strategy to Evaluate the Quality of Clinical Data from CROs Implementing CDISC Standards for Device-Drug Studies
Hands-on Training Creating & Sharing Shiny Apps & Gadgets
Leadership and Career Development It's a wonderful day in this neighbourhood - Managing a large virtual programming team Attracting and Retaining the Best! Statistical Programming Roles - Time to Reevaluate Job Profiles & Career Ladders Time to COMPARE Programmer to Analyst: Examine the Differences and Decide Best Path Forward
Programming Techniques Useful SAS techniques in Efficacy Analysis for Oncology studies ADaM 1.1 Compliant ADEVENT and ADTTE development in a Cardiovascular Study Implementing Laboratory Toxicity Grading for CTCAE Version 5 Code Generators: Friend or Foe
Statistics and Analytics Logistic and Linear Regression Assumptions: Violation Recognition and Control Jump Start your Oncology knowledge Comparing SAS® Viya® and SAS® 9.4: How Their Features Complement Each Other
Submission Standards Multiple Studies BIMO Submission Package - A Programmer's Perspective Non-Clinical (SEND) Reference Guide for Clinical (SDTM) Programmers Have You Met Define.xml 2.0? How to use SUPPQUAL for specifying natural key variables in define.xml?

Tuesday AM Late

Section 10:00 AM 10:15 AM 10:30 AM 10:45 AM 11:00 AM 11:15 AM 11:30 AM 11:45 AM
Advanced Programming Unleash the Power of Less Well Known but Useful SAS(r) DATA Step Functions Practices in CDISC End-to-End Streamlined Data Processing Tidyverse for Clinical Data Wrangling
Application Development Validating Hyperlinks in SDTM define.xml Using Python Use of SAS Merge in Adverse Events Reporting for DSUR Camouflage your Clinical Trial with Machine Learning and AI Reimagining Statistical Reports with R Shiny
Data Standards Practical Guide for Creating ADaM Datasets in Cross-over Studies
Data Standards Findings About: De-mystifying the When and How Considerations when Representing Multiple Subject Enrollments in SDTM Panel Discussion: Medical Devices - Implementation Through Submission
Hands-on Training Hands-on Training for Machine Learning Programming
Leadership and Career Development Improving the Relationship between Statisticians and Programmers in Clinical Trial Studies Pains and Gains in software development - from PoC to Market Working from a Home Office Versus Working On-Site Schoveing Series 4: Inspirational Leadership: Grow Yourself into a Class Act and an Unforgettable Leader!
Posters Bayesian Methods for Treatment Design in Rare Diseases
Posters A Cloud-based Framework for Exploring Medical Study Data
Posters When biomarker drives primary endpoint: An oncology case study of SDTM design using multiple myeloma.
Posters Why waiting longer to check log file when SAS program in Execution? Lets Find bugs Early!!
Posters Merging Sensor Data with Patient Records in Clinical Trials - Systems and Benefits
Programming Techniques A SAS® Macro to Provide Survival Functions along with Cox Regression Model Efficiently Patient Profile with Color-Coded Track Changes Since Last Review The Knight's Tour in 3-Dimensional Chess
Statistics and Analytics Equivalence, Superiority and Non-inferiority with Classical Statistical Tests: Implementation and Interpretation A macro of evaluating the performance of the log-rank test using different weight for enrichment studies SAS ® V9.4 MNAR statement for multiple imputations for missing not at random in longitudinal clinical trials Application of R Functions in SAS to Estimate Dose Limiting Toxicity Rates for Early Oncology Dose Finding
Submission Standards The Need for Therapeutic Area User Guide Implementation Considerations in Effectively Generating PK Analysis Input Datasets Pharmacokinetic Parameters for Sparse and Intensive Sampling - Nonclinical and Clinical Studies

Tuesday PM Early

Section 1:30 PM 1:45 PM 2:00 PM 2:15 PM 2:30 PM 2:45 PM 3:00 PM 3:15 PM 3:30 PM 3:45 PM
Advanced Programming Six Useful Data Tool Macros Confessions of a SAS PROC SQL Instructor
Application Development Best Practices for ISS/ISE Dataset Development Large-scale TFL Automation for regulated Pharmaceutical trials using CDISC Analysis Results Metatadata (ARM) User-Defined Multithreading with the SAS® DS2 Procedure: Performance Testing DS2 Against Functionally Equivalent DATA Steps
Data Standards Considerations and Updates in the Use of Timing Variables in Submitting SDTM-Compliant Datasets Bidirectionality to LOINC: Handling the Nitty Gritty of Lab Data This Paper focuses on CDISC Questionnaires, Ratings and Scales (QRS) supplements and types of FDA Clinical Outcome Assessments
Hands-on Training Build Popular Clinical Graphs using SAS
Leadership and Career Development Considering Job Changes in an Ever-Changing Environment Project Management Fundamentals for Programmers and Statisticians Something Old, Something New: A little programming management can go a long way Advance Your Career with PROC TM!
Programming Techniques Lit Value Locator: An efficient way to pinpoint data. Running Parts of a Program while Preserving the Entire Program ODS Magic: Using Lesser Known Features of the ODS statement Freq Out - Proc Freq's Quick Answers to Common Questions A Quick Way to Cross Check Listing Outputs Importing EXCEL Data in Different SAS Maintenance Release Version Create publication-ready variable summary table using SAS macro Compare and conquer SDTM coding
Statistics and Analytics Regulation Techniques for Multicollinearity: Lasso, Ridge, and Elastic Nets Experiences in Building CDISC Compliant ADaM Dataset to Support Multiple Imputation Analysis for Clinical Trials
Submission Standards Expediting Drug Approval: Real Time Oncology Review Pilot Program Information Requests During An FDA Review Process optimization for efficient and smooth e-data submissions to both FDA and PMDA Panel Discussion: Recent Submission Experiences around the World

Tuesday PM Late

Section 3:30 PM 3:45 PM 4:00 PM 4:15 PM 4:30 PM 4:45 PM 5:00 PM 5:15 PM
Advanced Programming Get Smart! Eliminate Kaos and Stay in Control - Creating a Complex Directory Structure with the DLCREATEDIR Statement Python-izing the SAS Programmer Minimally Invasive Surgery to Merge Data Generate Customized Table in RTF Format by Using SAS Without ODS RTF - RTF Table File Demystified
Application Development Interactive TLFs - A Smarter Way to Review your Statistical Outputs Tool Development Methods for Implementing and Converting to New Controlled Terminology in SDTM datasets A Utility to Automate Reconciliation of Report Numbers and Titles
Data Standards Achieving Zen: A Journey to ADaM Compliance Common Pinnacle 21 Report Issues: Shall we Document or Fix?
Hands-on Training Value-Level Metadata Done Properly
Leadership and Career Development The human side of programming: Empathetic leaders build better teams. Find Your Story Panel Discussion: Speaking Data Science, Who is Ready to Listen?
Posters F2Plots: Visualizing relative treatment effects in cancer clinical trials
Posters Tame your SHARE with a PYTHON and SAS
Posters SDSP (Study Data Standardization Plan) Case Studies and Considerations
Posters Flagging On-Treatment Events in a Study with Multiple Treatment Periods
Programming Techniques Making the Days Count: Counting Distinct Days in Overlapping or Disjoint Date Intervals From Lesion size to Best Response - Implementing RECIST through programming End of Computing Chores with Automation: SAS© Techniques That Generate SAS© Codes Let Your Log Do the Work for You An Overview of Three New Output Delivery System Procedures in SAS® 9.4: ODSTABLE, ODSLIST and ODSTEXT Using the PRXCHANGE Function to Remove Dictionary Code Values from the Coded Text Terms
Statistics and Analytics Practical Perspective in Sample Size Determination Cluster Analysis - What it is and How to use it Statistical Assurance in SAS: An Introduction and User's Guide
Submission Standards Do-It-Yourself CDISC! A Case Study of Westat's Successful Implementation of CDISC Standards on a Fixed Budget A Standardized Data Sample: Key to Improving the Submission Strategy De-Identification of Data & It's Techniques
Submission Standards Making Lab Toxicity Tables Less Toxic on Your Brain

Wednesday AM Early

Section 8:00 AM 8:15 AM 8:30 AM 8:45 AM 9:00 AM 9:15 AM 9:30 AM 9:45 AM 10:00 AM 10:15 AM 10:30 AM 10:45 AM
Advanced Programming PROC SQL to the Rescue: When a Data Step Just Won't Do Anymore Automating SAS Program Table of Contents for Your FDA Submission Package
FDA Wednesday Keynote Address: Regulatory Submissions in the PDUFA Era Study Data Topics at FDA/CDER CBER Data Standards Update
Hands-on Training Sample Size Determination with SAS® Studio
Programming Techniques Macro Templates - Industry Specific SAS® Programming Standardization SMQ SAS Dataset Macro
Reporting and Data Visualization Forest Plots for Beginners DOMinate your ODS Output with PROC TEMPLATE, ODS Cascading Style Sheets (CCS), and the ODS Document Object Model (DOM)
Statistics and Analytics Let's Flip: An Approach to Understand Median Follow-up by the Reverse Kaplan-Meier Estimator from a Programmer's Perspective Enhancing Randomization Methodology Decision-Making with SAS Simulations

Wednesday AM Late

Section 10:00 AM 10:15 AM 10:30 AM 10:45 AM 11:00 AM 11:15 AM 11:30 AM 11:45 AM
Advanced Programming Using SAS ® ODS EXCEL Destination "Print Features" to Format Your Excel Worksheets for Printing as You Create Them. From Static ggplot2 Output to Interactive Plotly Visualization to Shiny App
FDA Wednesday An Overview of How FDA Business Rules, FDA Validator Rules, and Others Fit Together FDA Panel Discussion: Evidence, Data and Review: Continuing the Discussion with FDA
Programming Techniques One More Paper on Dictionary Tables and Yes, I Think it Is Worth Reading Sum Fun with Flags! Sum Any Flagged Occurrence Data with FLAGSUM and Report It with FLAGRPT or PROC REPORT. History Carried Forward, Future Carried Back: Mixing Time Series of Differing Frequencies
Reporting and Data Visualization Visualize Overall Survival and Progression Free Survival at the Same Time! Building Automations for Generating R and SAS Code Supporting Visualizations Across Multiple Therapeutic Areas Fine-tuning your swimmer plot: another example from oncology
Statistics and Analytics An Introduction to the Process of Improving a Neural Network PROC MIXED: Calculate Correlation Coefficients in the Presence of Repeated Measurements Machine Learning Approaches to Identify Rare Diseases Application of Criterion I2 in Clinical Trials Using SAS®