Welcome to the PharmaSUG 2024 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 14-May-2024)

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
Advanced Programming	Creating Dated Archives Automatically with SAS®		Adding the missing audit trail to R		Comprehensive Evaluation of Large Language Models (LLMs) Such as ChatGPT in Biostatistics and Statistical Programming
Data Standards	Converting FHIR to CDASH using SAS		CDISC Therapeutic Area User Guides and ADaM Standards Guidance		Guidance Beyond the SDTM Implementation Guide
Data Visualization and Reporting	The Missing(ness) Piece: Building Comprehensive, Data Driven Missingness Reports and Codebooks Dynamically		Combining Functions and the POLYGON Plot to Create Unavailable Graphs Including Sankey and Sunburst Charts		A ‘Shiny’ New Perspective: Unveiling Next-Generation Patient Profiles for Medical and Safety Monitoring
Hands-on Training	Complex Custom Clinical Graphs Step by Step with SAS® ODS Statistical Graphics
Leadership Skills	Soft Skills to Gain a Competitive Edge in the 21st Century Job Market		Recruiting Neurodivergent Candidates using the Specialisterne Approach		What Being a Peer-to-Peer Mentor Offers – Perspective from an Individual Project Level Contributor
Metadata Management			Variable Subset Codelist		Methodology for Automating TOC Extraction from Word Documents to Excel
Real World Evidence and Big Data	Reconstruction of Individual Patient Data (IPD) from Published Kaplan-Meier Curves Using Guyot’s Algorithm: Step-by-Step Programming in R		Win a PS5! How to Run and Compare Propensity Score Matching Performance Across Multiple Algorithms in Five Minutes or Less		Interfacing with Large-scale Clinical Trials Data: The Database for Aggregate Analysis of ClinicalTrials.gov
Solution Development	AutoSDTM Design and Implementation With SAS Macros		Readlog Utility: Python based Log Tool and the First Step of a Comprehensive QC System		Define-XML Conversion: A General Approach on Content Extraction Using Python

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
Advanced Programming	Efficient Repetitive Task Handling in SAS Programming Through Macro Loops		Macro Variable Arrays Made Easy with macroArray SAS package				Just Stringing Along: FIND Your Way to Great User-Defined Functions
Data Standards	Advancing the Maturation of Standardized CRF Design		Automated Harmonization: Unifying ADaM Generation and Define.xml through ADaM Specifications		Implementation of composite estimands for responder analysis based on change from baseline in non-solid tumours		Guideline for Creating Unique Subject Identifier in Pooled studies for SDTM
Data Visualization and Reporting	Enhanced Spider Plot in Oncology		AutoVis Oncology Presenter: Automated Python-Driven Statistical Analysis and Visualizations for Powerful Presentations		Utilizing Data Visualization for Continuous Safety and Efficacy Monitoring within Early Development		Kaplan-Meier Graph: a comparative study using SAS vs R
Hands-on Training	The Art of Defensive SAS Programming				The New Shape Of SAS Code
Leadership Skills	Creating a Culture of Engagement – Role of a Manager		Data Harmony Revolution: Rocking Trials with Clinical Data Literacy		Leadership Lessons from Another Life: How my Previous Career Helped Me as a Statistician		Effectively Manage the Programming Team Using MS Team
Metadata Management	Optimizing Clinical Data Processes: Harnessing the Power of Metadata Repository (MDR) for Innovative Study Design (ISD) and Integrated Summary of Safety (ISS) / Efficacy (ISE)		Relax with Pinnacle 21’s RESTful API		A Practical Approach to Automating SDTM Using a Metadata-Driven Method That Leverages CRF Specifications and SDTM Standards
Real World Evidence and Big Data			A SAS® Macro Approach: Defining Line of Therapy Using Real-World Data in Oncology		Applications of Machine Learning and Artificial Intelligence in Real World Data in Personalized Medicine for Non-Small Cell Lung Cancer Patients		Towards understanding Neurological manifestations of Lyme disease through a machine learning approach with patient registry data
Solution Development	Safety Signals from Patient Narratives PLUS: Augmenting Artificial Intelligence to Enhance Generative AI Value		Benefits, Challenges, and Opportunities with Open-Source Software Integration				Bridging AI and Clinical Research: A New Era of Data Management with ChatGPT
Watercooler Chats	Becoming multi-lingual: Are you ready?				We all need to feel validated: R can help
ePosters			No LEAD Function? Let’s Create It!
ePosters			Integrity, Please: Three Techniques for One-Step Solution in Pharmaceutical Programming
ePosters			Comparing SAS® and R Approaches in Creating Multicell Dot Plots in Statistical Programming
ePosters			Upholding Blinding in Clinical Trials: Strategies and Considerations for Minimizing Bias

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	3:30 PM
Advanced Programming	An Introduction to the SAS Transpose Procedure and its Options		Generation of Synthetic Data for Clinical Trials in Base SAS using a 2-Phase Discrete-Time Markov and Poison Rare Event Framework				Externally Yours – Adeptly Managing Data Outside Your EDC System
Data Standards	Assurance in the Digital Age: Automating MD5 Verification for uploading data into a Cloud based Clinical Repository		Streamlining Patient-reported outcome (PRO) data standardization & analysis		Exploit the Window of Opportunity: Exploring the Use of Analysis Windowing Variables		Analyzing your SAS log with user defined rules using an app or macro.
Data Visualization and Reporting	Standardization of the Patient Narrative Using a Metadata-driven Approach		Creating Custom Excel Spreadsheets with Built-in Autofilters Using SAS® Output Delivery System (ODS)				Piloting data visualization and reporting with Rshiny apps
Hands-on Training			Hands-on Python PDFs: Using the pypdf Library To Programmatically Design, Complete, Read, and Extract Data from PDF Forms Having Digital Signatures
Leadership Skills	Translation from statistical to programming: effective communication between programmers and statisticians		Unlock Your Greatness: Embrace the Power of Coaching				Harmony in Motion: Nurturing Work-Life Balance for Sustainable Well-being
Metadata Management	Automating third party data transfer through digitized Electronic DTA Management		Managing a Single Set of SDTM and ADaM Specifications across All Your Phase 1 Trials
Real World Evidence and Big Data	Unraveling the Layers within Neural Networks: Designing Artificial and Convolutional Neural Networks for Classification and Regression Using Python’s Keras & TensorFlow
Solution Development	Integration of SAS GRID environment and SF-36 Health Survey scoring API with SAS Packages		Standardizing Validation Data Sets (VALDS) as matrices indexed by Page, Section, Row, and Columns (PSRC) to improve Validation and output creation and revisions.				Enhancing FDA Debarment List Compliance through Automated Data Analysis Using Python and SAS	Shift gears with ‘gt’: Finely tuned clinical reporting in R using “gt” and “gt summary” packages
Watercooler Chats	Partnering successfully: A dive in to sponsor/CRO relationships				Bringing Order to Chaos: Open-Source Tools for Data Integration and Visualization
ePosters			Enhancing Define-XML Generation: Based on SAS Programming and Pinnacle 21 Community
ePosters			If its not broke, don’t fix it; existing code and the programmers’ dilemma
ePosters			Best Function Ever: PROC FCMP
ePosters			Plotting Data by US ZIP Code

Monday PM Late

Section	4:00 PM	4:15 PM	4:30 PM	4:45 PM	5:00 PM	5:15 PM
Advanced Programming	Tips for Completing Macros Prior to Sharing		R Shiny and SAS Integration: Execute SAS Procs from Shiny Application		Build Your Own PDF Generator: A Practical Demonstration of Free and Open-Source Tools
Data Standards	Game changer! The new CDISC ADaM domain ADNCA for PK/PD data analysis		SDTM Specifications and Datasets Review Tips		AI and the Clinical Trial Validation Process – Paving a Rocky Road
Data Visualization and Reporting	Visual discovery in Risk-Based Monitoring using topological models				Exploring the Application of FDA Medical Query (FMQ) in Visualizing Adverse Event Data
Hands-on Training	Building Complex Graphics from Simple Plot Types
Leadership Skills	Go Get – Em: Manager’s Guide to Make a Winning Business Proposal for Technology Solutions		Adventures in Independent Consulting: Perspectives from Two Veteran Consultants Living the Dream
Solution Development	Advancing Regulatory Intelligence with conversational and generative AI		inspectoR: QC in R? No Problem!		“Prompt it”, not “Google it” : Prompt Engineering for Statistical Programmers and Biostatisticians
Strategic Implementation & Innovation	Agile, Collaborative, Efficient (ACE): A New Perspective on Data Monitoring Committee Data Review Preparation		LLM-Enhanced Training Agent for Statistical Programming		A Change is Gonna Come: Maintaining Company Culture, Managing Time Zones, and Integrating Teams after a Global Acquisition
Submission Standards	BIMO Brilliance: Your Path to Compliance Resilience		Study Start Date – Let’s Get it Right!		Leveraging SAS and Adobe Plug-in for CRF Bookmark Generation (Rave studies)

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
Advanced Programming	Create a Shift Summary of Laboratory Values in CTCAE Grade to the Worst Grade Abnormal Value using R and SASSY System		Potentials and Caveats When Using ChatGPT for Enhanced SAS Macro Writing		Comparison of Techniques in Merging Longitudinal Datasets with Errors on Date Variable: Fuzzy Matching versus Clustering Analysis
Data Standards	Programming Considerations in Deriving Progression-Free Survival on Next-Line Therapy (PFS2)		Your Guide to Successfully Upversioning CDISC Standards		I Want to Break Free: CRF Standardization Unleashing Automation
Data Visualization and Reporting	Amazing Graph Series: Swimmer Plot – Visualizing the Patient Journey: Adverse Event Severity, Medications, and Primary Endpoint		Splashy Graphics Suitable for Publication? ODS LAYOUT Can Do It!		Periodic safety reports of clinical trials
Hands-on Training	Understanding Administrative Healthcare Datasets using SAS ‘ programming tools.
Leadership Skills	Ongoing Trends and Strategies to Fine-tune the CRO/Sponsor Partnership – Perspectives from Statistical Programming		A Framework for Risk-Based Oversight for Fully Outsourced Clinical Studies
Solution Development	Automation of Report Generation Beyond Macro		Semi-Automated and Modularized Approach to Generate Tables for Clinical Study – Categorical Data Report		Utility Macros for Data Exploration of Clinical Libraries
Strategic Implementation & Innovation	The Role of the Blinded Programmer in Preparation of Data Monitoring Committee Packages (for Clinical Trials)		Navigating Success: Exploring AI-Assisted Approaches in Predicting and Evaluating Outcome of Clinical Trials and Submissions		Quality Assurance within Statistical Programming: A Systemic Way to Improve Quality Control
Submission Standards	Is a Participation-Level ADaM Dataset a Solution for Submitting Integration Data to FDA?		Challenges and Considerations When Building e-Submission SDTM Data Packages		Creating Adverse Event Tables using R and SASSY System
Watercooler Chats				Tips and tricks to spice up SAS: Defensive coding strategies
iConsult	Entity Types – Which One to Choose?		Show Me The Money! Promoting Your Consulting Business and Setting Your Rate		Importance of the Small Business Tax Workshop

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	12:00 PM
Advanced Programming	LAST CALL to Get Tipsy with SAS®: Tips for Using CALL Subroutines		Replicating SAS® Procedures in R with the PROCS Package		SAS® Super Duo: The Program Data Vector and Data Step Debugger
Data Standards	A quick guide to SDTM and ADaM mapping of liquid Oncology Endpoints.		ADaM Design for Prostate Cancer Efficacy Endpoints Based on PCWG3		Protocol Amendments and EDC Updates: Downstream impact on Clinical Trial Data		Around the Data DOSE-y Doe, How Much Fun Can Your Data Can Be: Using DOSExx Variables within ADaM Datasets
Data Visualization and Reporting	Pictorial Representation of Adverse Events (AE) Summary- ” A new perspective to look at the AE data in Clinical Trials		Quarto 1.4: Revolutionizing Open-source Dashboarding Capabilities		Automation and integration of data visualization using R ESQUISSE & R SHINY		A R Markdown Structure for Automatically Generating Presentation Slides
Hands-on Training			Deep Dive into the BIMO (Bioresearch Monitoring) Package Submission
Solution Development	Build up Your Own ChatGPT Environment with Azure OpenAI Platform				Unravelling the SDTM Automation Process through the Utilization of SDTM Transformation Template		The 5 CATs in the Hat – Sleek Concatenation String Functions
Statistics and Analytics	iCSR: A Wormhole to Interactive Data Exploration Universe		Generative Artificial Intelligence in sample size estimation – challenges, pitfalls, and conclusions		Bayesian Methods in Survival Analysis: Enhancing Insights in Clinical Research		Dealing with Missing Data: Practical Implementation in SAS and R
Strategic Implementation & Innovation			Validating R for Pharma – Streamlining the Validation of Open-Source R Packages within Highly Regulated Pharmaceutical Work		Facilitating Seamless SAS-to-R Transition in Clinical Data Analysis: A Finetuned LLM Approach		A fear of missing out and a fear of messing up : A Strategic Roadmap for ChatGPT Integration at Company Level
Submission Standards	Cultivating Success with Non-standard Investigator-sponsored Trial Data for FDA Submissions		Combine PDFs in Submission-ready Format Quick and Easy		How to generate a submission ready ADaM for complex data		Piloting into the Future: Publicly available R-based Submissions to the FDA
Watercooler Chats	Open source journeys in the Life Sciences				Sustainably engaging your workforce in a changing world
ePosters			A Deep Dive into Enhancing SAS/GRAPH® and SG Procedural Output with Templates, Styles, Attributes, and Annotation
ePosters			A Simple Way to Make Adaptive Pages in Listings and Tables
ePosters			An approach to make Data Validation and Reporting tool using R Shiny for Clinica Data Validation
ePosters			Simplifying Edit Check Configuration
iConsult	Ctrl + S(hare): A Programmer’s Advice for Leveraging Social Media		Insight Into Issues and Accounting Methods		The Pitfalls of Self-Employed Individuals		Tax Breaks for the Average Joe/Jane

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
Advanced Programming	A New Approach to Automating the Creation of the Subject Visits (SV) Domain				Programming with SAS PROC DS2: Experience with SDTM/ADaM		Leveraging ChatGPT in Statistical Programming in the Pharmaceutical Industry
Data Standards	Handling of Humoral and Cellular Immunogenicity Data in SDTM		ADaM Discussion Topics: PARQUAL, ADPL, Nadir		A New Way to Automate Data Validation with Pinnacle 21 Enterprise CLI in LSAF
Data Visualization and Reporting	Reimagining reporting and Visualization during clinical data management		Tales From A Tech Support Guy: The Top Ten Most Impactful Reporting and Data Analytic Features for the SAS Programmer				Next level Reporting: ODS and Open Source
Hands-on Training			A Gentle Introduction to SAS Packages
Solution Development	Five Reasons To Swipe Right on PROC FCMP, the SAS Function Compiler for Building Modular, Maintainable, Readable, Reusable, Flexible, Configurable User-Defined Functions and Subroutines				Excel Email Automation Tool: Streamlining Email Creation and Scheduling		Two hats, one noggin: Perspectives on working as a developer and as a user of the admiral R package for creating ADaMs.
Statistics and Analytics	Demystifying Incidence Rates: A Step-by-Step Guide to Adverse Event Analysis for Novice Programmers		Estimating Time to Steady State Analysis in SAS		Opportunities and Challenges for R as an open-sourced solution for statistical analysis and reporting, from vendor’s perspective		Versatile and efficient graphical multiple comparison procedures with {graphicalMCP}
Strategic Implementation & Innovation	aCRF Copilot: Pioneering AI/ML Assisted CRF Annotation for Enhanced Clinical Data Management Efficiency		SASBuddy: Enhancing SAS Programming with Large Language Model Integration		Agile Sponsor Oversight of Statistical Programming Activities		PHUSE Safety Analytics Working Group – Overview and Deliverables Update
Submission Standards			Lead-in and extension trials, how we documented datapoint traceability		A Programmer’s Insight into an Alternative to TQT Study Data Submission		Submitting Patient-Reported Outcome Data in Cancer Clinical Trials- Guidance for Industry Technical Specifications Document
Watercooler Chats	Advancing Innovation with AI/ML in the Real World				Gen AI, LLM, and ChatGPT Integration: Where do we go From Here?
ePosters			The Survival Mode
ePosters			Updates on Preparing a BIMO Data Package
ePosters			Elevate Your Game: Leveling Up SDTM Validation with the Magic of Data Managers
ePosters			The SAS Genome – Genetic Sequencing

Tuesday PM Late

Section	4:00 PM	4:15 PM	4:30 PM	4:45 PM	5:00 PM	5:15 PM
Data Visualization and Reporting	Ten Rules for Better Charts, Figures and Visuals				Interactive Data Analysis and Exploration with composR: See the Forest AND the Trees
Hands-on Training	Transitioning from SAS to R
Solution Development	Developing Web Apps in SAS Visual Analytics		Streamlined EDC data to SDTM Mapping with Medidata RAVE ALS		A Tool for Automated Comparison of Core Variables Across ADaM Specifications Files
Statistics and Analytics	Source Data Quality Issues in PopPK/PD Dataset Programming: a Systematic Approach to Handle Duplicates		Relative Dose Intensity in Oncology Trials: A Discussion of Two Approaches		Bayesian Additive Regression Trees for Counterfactual Prediction and Estimation
Strategic Implementation & Innovation	One size does not fit all: The need and art of customizing SCE and MDR for end users		Embracing Diversity in Statistical Computing Environments: A Multi-Language Approach		Automating the annotation of TLF mocks Using Generative AI
Submission Standards	Design Considerations for ADaM Protocol Deviations Dataset in Vaccine Studies		Experimenting with Containers and webR for Submissions to FDA in the Pilot 4

Wednesday AM Early

Section	8:00 AM	8:15 AM	8:30 AM	8:45 AM	9:00 AM	9:15 AM
Data Visualization and Reporting	An introduction to Quarto: A Versatile Open-source Tool for Data Reporting and Visualization		Exploring DATALINEPATTERNS, DATACONTRASTCOLORS, DATASYMBOLS, the SAS System® REGISTRY procedure, and Data Attribute Maps (ATTRMAP) to assign invariant attributes to subjects and arms throughout
Hands-on Training		GenAI to Enhance Your Statistical Programming
Statistics and Analytics	MLNR or Machine Learning in R		Bayesian Hierarchical Models with the Power Prior Using PROC BGLIMM		Data Literacy 101: Understanding Data and the Extraction of Insights

Wednesday AM Late

Section	9:45 AM	10:00 AM	10:15 AM	10:30 AM
Statistics and Analytics	Multiple Logistic Regression Analysis using Backward Selection Process on Objective Response Data with SAS®		Oncology ADaM Datasets Creation Using R Programming: A Comprehensive Approach