Welcome to the PharmaSUG 2023 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 05-May-2023)

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 A Configuration File Companion: testing and using environment variables and options; templates for startup-only options initstmt and termstmt Using SQL Dictionaries to Research the Global Symbol Table Have a Date with ISO®? Using PROC FCMP to Convert Dates to ISO 8601
Data Standards The Phantom of the ADaM: adding missing records to BDS datasets Why FDA Medical Queries (FMQs) for Adverse Events of Special Interest? Implementation and Case Study Sound SDTM, Sound ADaM - Orchestrating SDTM and ADaM Harmonization
Data Visualization and Reporting Ten Rules for Better Charts, Figures and Visuals Meta-Analysis in R
Hands-On Training Generating Clinical Graphs in SAS and R - A Comparison of the Two Languages
Quick Programming Tips A SAS® Macro to Convert CSV files to SAS Datasets Running Parts of a SAS Program while Preserving the Entire Program A Macro to Identify Repeating SAS(r) BY Variables in a MERGE Confirmation of Best Overall Tumor Response in Oncology Clinical Trials per RECIST 1.1 Repetitive Analyses in SAS® - Use of Macros Versus Data Inflation and BY Group Processing Macro Code to Test Existence of Various Objects
Real World Evidence and Big Data Real World Evidence in Distributed Data Networks: Lessons from a Post-Marketing Safety Study Exploring the spread of COVID-19 in the United States using unsupervised graph-based machine learning
Solution Development Application of Tipping Point Analysis in Clinical Trials using the Multiple Imputation Procedure in SAS Do it the smart way, renumber with PowerShell scripts! A Macro Utility for CDISC Datasets Cross Checking

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 Best Practices for Efficiency and Code Optimization in SAS programming Twenty Ways to Run Your SAS® Program Faster and Use Less Space A utility to combine study outputs into all-in-one PDF for DSUR Automation of Validation of QC Plan Entries and Managing SAS Programs
Data Standards Leverage and Enhance CDISC TAUGs to Build More Traceability for and Streamline Development of Efficacy ADaM in Oncology Studies SDTM Variables You Might Forget About From Sea to shining sea - End to End discussion on PR and LB data
Data Visualization and Reporting Divergent Nested Bar Plot and SAS Implementation Methods of a Fully Automated CONSORT Diagram Macro %CONSORT Revolutionizing Statistical Outputs Validation: a Product Demonstration of Verify, an ML-powered Automation Solution Streamlining the Validation Process
Hands-On Training Undo SAS® Fetters with Getters and Setters-Supplanting Macro Variables with More Flexible, Robust PROC FCMP User-Defined Functions That Perform In-Memory Lookup and Initialization Operations
Panel Discussion Executive Technology
Quick Programming Tips Tips to Read In and Output Excel Spreadsheets in SAS With a View to Make Your Metadata Function(al): Exploring the FMTINFO() Function Put on the SAS® Sorting Hat and Discover Which Sort is Best for You! A utility tool to assist with the setup of the startup environment for remote access Running Python Code inside a SAS Program Let the Data Drive it and set your hands free - A Macro to create indicators for Special Interest AEs 10 Quick Tips for Getting Tipsy with SAS
Real World Evidence and Big Data Patient's Journey using Real World Data and its Advanced Analytics CMS VRDC - A simplified overview. What to expect in terms of data, system, code. Automating Non-Standard New Study Set Up with a SAS Based Work Process
Solution Development Data Access Made Easy Using SAS® Studio Battle of the Titans (Part II): PROC REPORT versus PROC TABULATE
e-Posters Visualization for Success: Driving KPIs and Organizational Process Improvements via Portfolio-level Analytics
e-Posters Data Doesn't Lie - Real Time Monitoring and Projecting on Clinical Trial Enrollment Progression

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 Documenting your SAS programs with Doxygen and automatically generated diagrams. Friends are better with Everything: A User's Guide to PROC FCMP Python Objects in Base SAS
Data Standards CDISC SDTM IG v3.4: Subject Visits Questionnaires in ADaM: ADSF36 Have Meaningful Relationships: An Example of Implementing SDTM Special Purpose Data Set RELREC with a Many-to-Many Relationship Automation of the SDSP CBER Appendix for Vaccine Studies
Data Visualization and Reporting Post-surgical opioid pain medications usage evaluation using SAS and Excel Life Table Analysis for Time to First Event Onset Amazing Graph Series: Butterfly Graph Using SGPLOT and GTL The Flexible Ways to Create Graphs for Clinical Trial
Hands-On Training R package validation
Quick Programming Tips Smart Use of SAS Output System and SAS Macro for Statistic Test Selection SAS Macro to Automate Programmer Status Sheet A SAS® System Macro to Quickly Display Discrepant Values that are too Long for the COMPARE Procedure Output. Using P21 Checks to Help Your DM Out! How to generate questionnaire data compliance report Taming the Large SAS® Dataset by Splitting it Up R Tables via GT for Regulatory Submissions Are you planning to create/validate CDISC data set in R? Here is a step-by-step guide!
Real World Evidence and Big Data Novel Applications of Real World Data in Clinical Trials: External Control Arms Novel Applications of Real World Data in Clinical Trial Operations: Clinical Trial Feasibility
Solution Development Introduction of Developing Resistance Dataset A SAS Macro to Perform Consistency Check in CSR Footnote References Importance of Creating a Learning Portal for Statistical Programming End-to-End Processes Building an Internal R Package for Statistical Analysis and Reporting in Clinical Trials: A SAS User's Perspective
e-Posters Submission survival guidelines for Statistical Programmers
e-Posters Programmer's Perspective: Step into Awareness Regarding Clinical Trial Deliverables and Their Impact
e-Posters Implementing Agile Methodologies: Using Trello™ to Generate and Optimize Kanban Boards for Recurring SAS Programming Tasks

Monday PM Late

Section 4:00 PM 4:15 PM 4:30 PM 4:45 PM 5:00 PM 5:15 PM
Advanced Programming A Quick Look at Fuzzy Matching Programming Techniques Using SAS® Software Going Command(o): Power(Shell)ing Through Your Workload
Data Standards Integrated Trial Design Model Datasets? ADaM Design and Programming Standardization for Oncology Efficacy Endpoints Based on RECIST 1.1 Can We Do It Better? Real-Time Validation Of Sdtm Mapping Is Superior To Double Programming
Data Visualization and Reporting Complementary Overlay - A Programmatic Approach to Figure Output Validation
Hands-On Training Understanding Administrative Healthcare Datasets using SAS programming tools.
Metadata Management Challenges with Metadata Repository System Implementation: A Sponsor's Perspective Gear up the Metadata - Automating Patient Profile Generation, a Metadata Driven Programming Approach
Quick Programming Tips SAS Macro Design Considerations to Generate Subgroup Table and Forest Plot in Oncology Studies Assign Character Values from Logical Expression with CHOOSEC
Solution Development Bringing it All Together: Applying the Analytics Life Cycle for Natural Language Processing to Life Sciences Low Code Approach to Clinical Application Development using SAS Studio Custom Step
Submission Standards As Simple as Falling Off a Log?: An Unusual Case Study of Mapping Data into the SDTM DA (Drug Accountability) Domain Handling CRS/NT Data in CAR-T Studies and Submission

Tuesday AM Early

Section 8:00 AM 8:15 AM 8:30 AM 8:45 AM 9:00 AM 9:15 AM
Advanced Programming RESTful Thinking: Using R Shiny and Python to streamline REST API requests and visualize REST API responses Using the R interface in SAS ® to Call R Functions and Transfer Data
Data Standards Hard Coding: What is it? Why Does It Matter? What Should You Do When Faced With Such A Request? Handling Anti-Drug Antibody (ADA) Data for Efficient Analysis 'TUFF' LOVE: SDTM Pain Points EXPLAINED!
Freelancers Forum Freelancers Forum Block 1
Hands-On Training Commit early, commit often! A gentle introduction to the joy of Git and GitHub
Metadata Management Masters of the Table Universe: Creating Table Shells Consistently and Efficiently Across All Studies Traceability: Not just about Data
Solution Development Effective APIs for SAS Language Applications Acceleration and automation of genomic data analysis to meet corporate compliance standards using advanced cloud components
Strategic Implementation & Innovation What's the story in your subgroup analysis Digital Data Flow (DDF) and Technological Solution Providers Auto-validation of SAS Macros through Regression Testing
Submission Standards Optimizing Efficiency and Improving Data Quality through Meaningful Custom Fix Tips and Explanations CDISC Conformance and Compliance: So Many Resources, So Little Time! Study Data Technical Rejection Criteria (TRC) Considerations for Multiple Data Packages in a Single Submission

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 Top 5 gotchas for getting cloud ready in SAS Viya Sorting a Bajillion Variables-When SORTC and SORTN Subroutines Have Stopped Satisfying, User-Defined PROC FCMP Subroutines Can Leverage the Hash Object to Reorder Limitless Arrays An Introduction to Obtaining Test Statistics and P-Values from SAS® and R for Clinical Reporting
Freelancers Forum Freelancers Forum Block 2
Hands-On Training Blastula for Communicating Clinical Insights with R via Email
Metadata Management All You Need to Know about the New CDISC Analysis Results Standards! Automating SDTM: A metadata-driven journey.
Solution Development Was the load okay? SAS® System Macros to Summarize the COMPARE Procedure Results and SAS Logs for a Directory or Single File.
Statistics and Analytics A Macro to Apply Exclusion Criteria to SAS(r) PK data Statistical Considerations and Methods for Handling Missing Outcome Data in Clinical Trials During the Era of COVID-19
Strategic Implementation & Innovation Fitting Logitoid-Normal distributions with MLE estimate by SAS SEVERITY and FCMP procedures We Can Work it Out: Dos and Don'ts for Small Biotech and CRO NDA/BLA submission partnership Key Safety Assessments following Chimeric Antigen Receptor (CAR) T-cell Therapy in Early Development Oncology Key Statistical Programming Considerations in External Collaborative Clinical Trials
Submission Standards Standardization of Reactogenicity Data into Findings Consistency Checks Automation across Regulatory Submission Documents in the eCTD M5 folder How Can I Put This? - Using a pre-defined spreadsheet to explain your Pinnacle 21 Enterprise Issues Proposal for New ADaM Paired Variables: PARQUAL/PARTYPE
e-Posters What PROC SQL can't handle while Data Step can?
e-Posters Real Time Analytical Reporting Using OpenFDA
e-Posters A model for sponsors to support independent operation of IDMCs in clinical trials.

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
Advanced Programming Facilitating Complex String Manipulations Using SAS PRX Functions Strategies for Code Validation at Statistical Center for HIV/AIDS Research and Prevention (SCHARP) Creating The cxtf Native SAS Test Framework
Hands-On Training Sas Sql 101
Leadership Skills Adventures in Independent Consulting: Perspectives from Two Veteran Consultants Living the Dream
Metadata Management Macro to Automate Creation and Sync of Shell Document and TOC Better CDISC Standards with Metadata Programming
Panel Discussion DEI Panel
Solution Development A Light-Weight Framework to Manage Programs and Run All the TLFs in R Automated Mockup Table and Metadata Generator Tired of Manual Language Translation? Give it a REST! Using R to Create Population Pharmacokinetic Dataset
Statistics and Analytics Picking Scabs and Digging Scarabs: Refactoring User-Defined Decision Table Interpretation Using the SAS® Hash Object To Maximize Efficiency and Minimize Metaprogramming A Pain in My ISR - A Primer to Injection Site Reactions
Strategic Implementation & Innovation Automation of Dataset Programming Based on Dataset Specification Integrating Practices: How Statistical Programmers Differ and Align Within User Groups An End-to-End and Fully Integrated Clinical Development Platform with eDC/Labs data Data Management, Medical Review, Statistical Analysis and Adaptive Design etc. SAS LOG/LST Filename improvement for easier: code review, code audit and project development history and chronology.
Submission Standards Working with Biomedical Concepts and SDTM Dataset Specializations for Define-XML using SAS© Open CST ADaM Datasets with Multiple Participations per Subject Regulatory Data Submission and CDISC Compliance: Sponsor and Vendor Collaboration Best Practices
e-Posters Creating a Centralized Controlled Terminology Mapping Repository
e-Posters Using R to Automate Clinical Trial Data Quality Review
e-Posters The Effect of Bethanechol on Tracheobronchomalacia in Infants

Tuesday PM Late

Section 4:00 PM 4:15 PM 4:30 PM 4:45 PM 5:00 PM 5:15 PM
Advanced Programming Real Projects, Real Transition, Really Revolutionary - Transitioning to R for Biometrics Work Make You Holla' Tikka Masala: Creating User-Defined Informats Using the PROC FORMAT OTHER Option To Call User-Defined FCMP Functions That Facilitate Data Ingestion Data Quality You can REST easy generating Synthetic Data
Hands-On Training Introducing TFL Designer: Community Solution to Automate Development of Mock-up Shells and Analysis Results Metadata
Leadership Skills Practical Tips for Effective Coaching for Leaders and Managers in Organizations Are you a great team player?
Solution Development Using Bundles for R Package Management R Package Quality & Validation: Current Landscape
Statistics and Analytics Validating novel maraca plots - R and SAS love story Deep Learning to Classify Adverse Events from Patient Narratives Sensitivity Analysis for Missing Data Using Control-based Pattern Imputation
Strategic Implementation & Innovation Introduction of AWS Cloud Computing and its future for Biometric Department Tips and traps on how to efficiently accelerate clinical trials to successful submission, approval, and launch The implementation of Scrum in Pharmaceutical Data Analytics and Statistical Programming
Submission Standards A case study of a successful RTOR submission and approval for Rylaze BIMO Package: Challenges and Perspectives while keeping up with the upgrades in the BIMO Technical Conformance Guide and the BDRG Guidelines From FDA to PMDA submission: How to resolve CDISC non-compliance issues

Wednesday AM Early

Section 8:00 AM 8:15 AM 8:30 AM 8:45 AM 9:00 AM 9:15 AM
Advanced Programming Survival Methods for Crossover in Oncology Trials Program It Forward! - Thinking Downstream when Coding No More Manual PDF Bookmarks! An Automated Approach to Converting RTF Files to a Consolidated PDF with Bookmarks
Hands-On Training SAS Enterprise Guide: 8.x (What is new!)
Leadership Skills Developing and running an in-house SAS Users Group The Interview Process: An Autistic Perspective Lessons Learned from a Retired SAS® Programmer
Solution Development Automating Data Validations with Pinnacle 21 Command Line Interface Standardized data handling framework for wearables Making Publication Metric Tracking Easy: Using an Automated, Integrated System of R, SAS®, and Microsoft Power BI to Ease the Pain of Assessing Publication Metrics
Statistics and Analytics Shifting the drug development paradigm with Adaptive Design and master protocol What is Machine Learning, anyway? SAS-based Method for PK Noncompartmental Analysis and Validation
Strategic Implementation & Innovation Making Multilingual Programmers - A Targeted Approach to R for Clinical Trials Training Secret SAS - You Can Write eCTD Using ODS Word in SAS PHUSE Safety Analytics Working Group - Overview and Deliverables Update
Submission Standards Recent updates in BIMO Technical conformance guidance and use case scenario Industry metrics for standards utilization and validation rules F2: FAIR and Filing - Assessing Data Fitness for FAIR and Filing

Wednesday AM Late

Section 9:45 AM 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 Display Layout Specifications to Flexibly Design and Generate Tables Macro To Automate Crossover Review In Produced Outputs
Leadership Skills Planning Your Next Career Move - Resume Tips for the Statistical Programmer What's the F in specialized people? Let's talk FSP - the models, variations, and what it takes to be successful Get a GPS to navigate your skills to find career purpose
Panel Discussion FDA Panel
Solution Development Be a Lazy Validator - Let Your Code Do the Work Admiralonco - the cross-company R package for Oncology admirers Exploring the use of AI-based image recognition and Machine Learning to Improve the Efficiency and Accuracy of TLFs Validation Process.
Statistics and Analytics Guidelines for the Statistical Analysis in German Dossier Submissions
Strategic Implementation & Innovation Metaverse in the Healthcare - More Real than imagined! R Package Qualification: Automation and Documentation in a Regulated Environment
Submission Standards Adopting the New Integrated Analysis Data Reviewer's Guide (iADRG) Handling of Vaccine SDTM Data for FDA CBER/OVRR Submission Compliance