Baltimore, Maryland
May 19-22, 2024

Advanced Programming

AP-102. Creating Dated Archives Automatically with SAS®
Derek Morgan, Bristol Myers Squibb

AP-108. Macro Variable Arrays Made Easy with macroArray SAS package
Bart Jablonski, yabwon

AP-135. LAST CALL to Get Tipsy with SAS®: Tips for Using CALL Subroutines
Lisa Mendez, Catalyst Clinical Research
Richann Watson, DataRich Consulting

AP-138. An Introduction to the SAS Transpose Procedure and its Options
Timothy Harrington, Navitas Data Sciences

AP-144. SAS® Super Duo: The Program Data Vector and Data Step Debugger
Charu Shankar, SAS Institute

AP-175. Tips for Completing Macros Prior to Sharing
Jeffrey Meyers, Regeneron Pharmaceuticals

AP-191. Comprehensive Evaluation of Large Language Models (LLMs) Such as ChatGPT in Biostatistics and Statistical Programming
Songgu Xie, Regeneron Pharmaceuticals
Michael Pannucci, Arcsine Analytics
Weiming Du, Alnylam Pharmaceuticals
Huibo Xu, Greenwich High School
Toshio Kimura, Arcsine Analytics

AP-212. R Shiny and SAS Integration: Execute SAS Procs from Shiny Application
Samiul Haque, SAS Institute
Jim Box, SAS Institute

AP-218. Potentials and Caveats When Using ChatGPT for Enhanced SAS Macro Writing
Xinran Luo, Everest Clinical Research
Weijie Yang, Everest Clinical Research

AP-229. Create a Shift Summary of Laboratory Values in CTCAE Grade to the Worst Grade Abnormal Value using R and SASSY System
Vicky Yuan, Incyte Coperation

AP-252. Externally Yours – Adeptly Managing Data Outside Your EDC System
Frank Canale, SoftwaRx, LLC

AP-253. Build Your Own PDF Generator: A Practical Demonstration of Free and Open-Source Tools
*** BEST PAPER ***
James Austrow, Cleveland Clinic

AP-256. Leveraging ChatGPT in Statistical Programming in the Pharmaceutical Industry
Ian Sturdy, Eli Lilly and Company

AP-268. A New Approach to Automating the Creation of the Subject Visits (SV) Domain
Xiangchen Cui, Crisprtx Therapeutics
Jessie Wang, CRISPR Therapeutics
Min Chen, CRISPR Therapeutics

AP-289. Programming with SAS PROC DS2: Experience with SDTM/ADaM
Jianfeng Wang, UNIVERSITY OF MINNESOTA TWIN CITIES, MINNEAPOLIS, MINNESOTA
Li Cheng, Vertex Pharmaceuticals Inc.

AP-295. Replicating SAS® Procedures in R with the PROCS Package
*** BEST PAPER ***
David Bosak, r-sassy.org

AP-298. Comparison of Techniques in Merging Longitudinal Datasets with Errors on Date Variable: Fuzzy Matching versus Clustering Analysis
Huitong Niu, Master of Science Student, Biostatistics, Fielding School of Public Health, University of California, Los Angeles
Yan Wang, Adjunct Assistant Professor, Public and Population Health, School of Dentistry, University of California, Los Angeles

AP-349. Just Stringing Along: FIND Your Way to Great User-Defined Functions
Richann Watson, DataRich Consulting
Louise Hadden, Abt Global Inc.

AP-361. Efficient Repetitive Task Handling in SAS Programming Through Macro Loops
Chary Akmyradov, Arkansas Children's Research Institute

AP-420. Generation of Synthetic Data for Clinical Trials in Base SAS using a 2-Phase Discrete-Time Markov and Poison Rare Event Framework
Adam Yates, Data Coordinating and Analysis Center (DCAC), HJF-MHRP
Misti Paudel, Brigham and Women's Hospital Division of Rheumatology, Inflammation, and Immunity, Harvard School of Medicine
Fengming Hu, Data Coordinating and Analysis Center (DCAC), HJF-MHRP

AP-424. Adding the missing audit trail to R
Magnus Mengelbier, Limelogic AB



Data Standards

DS-109. Analyzing your SAS log with user defined rules using an app or macro.
Philip Mason, Wood Street Consultants

DS-130. SDTM Specifications and Datasets Review Tips
Wanchian Chen, AstraZeneca

DS-150. Assurance in the Digital Age: Automating MD5 Verification for uploading data into a Cloud based Clinical Repository
Laura Elliott, SAS Institute Inc.
Ben Bocchicchio, SAS

DS-154. Exploit the Window of Opportunity: Exploring the Use of Analysis Windowing Variables
Richann Watson, DataRich Consulting
Elizabeth Dennis, EMB Statistical Solutions, LLC
Karl Miller, IQVIA

DS-188. Automated Harmonization: Unifying ADaM Generation and Define.xml through ADaM Specifications
Wei Shao, Bristol Myers Squibb
Xiaohan Zou, Bristol Myers Squibb

DS-193. Around the Data DOSE-y Doe, How Much Fun Can Your Data Can Be: Using DOSExx Variables within ADaM Datasets
Inka Leprince, PharmaStat, LLC
Richann Watson, DataRich Consulting

DS-204. ADaM Discussion Topics: PARQUAL, ADPL, Nadir
Sandra Minjoe, ICON PLC

DS-205. A New Way to Automate Data Validation with Pinnacle 21 Enterprise CLI in LSAF
Crystal Cheng, SAS

DS-271. Programming Considerations in Deriving Progression-Free Survival on Next-Line Therapy (PFS2)
Alec McConnell, BMS
Yun Peng

DS-274. Guidance Beyond the SDTM Implementation Guide
Kristin Kelly, Pinnacle 21 by Certara
Michael Beers, Pinnacle 21

DS-276. Your Guide to Successfully Upversioning CDISC Standards
Soumya Rajesh, CSG Llc. - an IQVIA Business

DS-280. I Want to Break Free: CRF Standardization Unleashing Automation
Laura Fazio, Formation Bio
Andrew Burd, Formation Bio
Emily Murphy, Formation Bio
Melanie Hullings, Formation Bio

DS-287. ADaM Design for Prostate Cancer Efficacy Endpoints Based on PCWG3
Lihui Deng, Bristol Myers Squibb
Kylie Fan, BMS
Jia Li, BMS

DS-305. Guideline for Creating Unique Subject Identifier in Pooled studies for SDTM
Vibhavari Honrao, Ephicacy Lifescience Analytics

DS-310. Converting FHIR to CDASH using SAS
Pritesh Desai, sas
Mary Liang, SAS

DS-342. CDISC Therapeutic Area User Guides and ADaM Standards Guidance
Karin LaPann, CDISC independent contractor

DS-353. Protocol Amendments and EDC Updates: Downstream impact on Clinical Trial Data
Anbu Damodaran, Alexion Pharmaceuticals
Ram Gudavalli, Alexion Pharmaceuticals
Kumar Bhimavarapu, Alexion Pharmaceuticals

DS-360. A quick guide to SDTM and ADaM mapping of liquid Oncology Endpoints.
*** BEST PAPER ***
Swaroop Kumar Koduri, Ephicacy Lifescience Analytics Pvt Ltd
Shashikant Kumar, Ephicacy Lifescience Analytics
Sathaiah Sanga, Ephicacy Lifescience Analytics

DS-367. Handling of Humoral and Cellular Immunogenicity Data in SDTM
Wei Duan, Moderna Therapeutics

DS-374. Implementation of composite estimands for responder analysis based on change from baseline in non-solid tumours
Reshma Radhakrishnan, Ephicacy Lifescience Analytics

DS-388. Advancing the Maturation of Standardized CRF Design
Rubha Raghu, Algorics
Sugumaran Muthuraj, Algorics
Vijayakumar Radhakrishnan, Algorics
Nithiyanandhan Ananthakrishnan, Algorics

DS-398. Streamlining Patient-reported outcome (PRO) data standardization & analysis
Varsha Mithun Patil, Ephicacy
Mrityunjay Kumar, Ephicacy Lifescience Analytics

DS-400. AI and the Clinical Trial Validation Process – Paving a Rocky Road
Steve Ross, NA
Ilan Carmeli, NA

DS-406. Game changer! The new CDISC ADaM domain ADNCA for PK/PD data analysis
Santosh Ranjan, IQVIA



Data Visualization and Reporting

DV-127. The Missing(ness) Piece: Building Comprehensive, Data Driven Missingness Reports and Codebooks Dynamically
Louise Hadden, Abt Global Inc.

DV-155. Combining Functions and the POLYGON Plot to Create Unavailable Graphs Including Sankey and Sunburst Charts
Jeffrey Meyers, Regeneron Pharmaceuticals

DV-170. Creating Custom Excel Spreadsheets with Built-in Autofilters Using SAS® Output Delivery System (ODS)
Kirk Paul Lafler, sasNerd

DV-186. Enhanced Spider Plot in Oncology
Ilya Krivelevich, Eisai Inc.
Cixin He, Eisai inc.
Binbin Zhang-Wiener, Eisai Inc.
Wenyin Lin, Eisai Inc

DV-216. Utilizing Data Visualization for Continuous Safety and Efficacy Monitoring within Early Development
Margaret Wishart, Bristol Myers Squibb
Tamara Martin, Bristol Myers Squibb

DV-222. Kaplan-Meier Graph: a comparative study using SAS vs R
Mrityunjay Kumar, Ephicacy Lifescience Analytics
Shashikant Kumar, Ephicacy Lifescience Analytics

DV-246. AutoVis Oncology Presenter: Automated Python-Driven Statistical Analysis and Visualizations for Powerful Presentations
Indraneel Narisetty, Jazz Pharmaceuticals

DV-278. Standardization of the Patient Narrative Using a Metadata-driven Approach
Kuldeep Sen, Pfizer

DV-283. Exploring the Application of FDA Medical Query (FMQ) in Visualizing Adverse Event Data
Tongda Che, Merck
Danfeng Fu, MSD

DV-293. Splashy Graphics Suitable for Publication? ODS LAYOUT Can Do It!
Dave Hall, BridgeBio Pharma

DV-313. Visual discovery in Risk-Based Monitoring using topological models
Kostiantyn Drach, Intego Group
Iryna Kotenko, Intego Group

DV-323. Tales From A Tech Support Guy: The Top Ten Most Impactful Reporting and Data Analytic Features for the SAS Programmer
Chevell Parker, SAS Institute

DV-327. A R Markdown Structure for Automatically Generating Presentation Slides
Junze Zhang, Merck Co., Inc
Chuanhai Tang, Merck & Co., Inc.
Xiaohui Wang, Merck & Co., Inc.

DV-328. Next level Reporting: ODS and Open Source
Chevell Parker, SAS Institute

DV-331. Ten Rules for Better Charts, Figures and Visuals
Kirk Paul Lafler, sasNerd

DV-348. Periodic safety reports of clinical trials
Murali Kanakenahalli, Kite Pharma
Annette Bove, ClinChoice Inc
Smita Sehgal, Orbis Clinical

DV-380. Amazing Graph Series: Swimmer Plot - Visualizing the Patient Journey: Adverse Event Severity, Medications, and Primary Endpoint
Tracy Sherman, Ephicacy
Aakar Shah, Acadia Pharmaceuticals Inc.

DV-382. A 'Shiny' New Perspective: Unveiling Next-Generation Patient Profiles for Medical and Safety Monitoring
Helena Belloff, Formation Bio
William Lee, Formation Bio
Melanie Hullings, Formation Bio

DV-389. Automation and integration of data visualization using R ESQUISSE & R SHINY
Vijayakumar Radhakrishnan, ALGORICS
Nithiya Ananthakrishnan, Algorics

DV-395. Pictorial Representation of Adverse Events (AE) Summary– A new perspective to look at the AE data in Clinical Trials
Pradeep Acharya, Ephicacy Lifescience Analytics
Anurag Srivastav, Ephicacy

DV-396. Piloting data visualization and reporting with Rshiny apps
Yun Ma, boehringer-ingelheim
Yifan Han, boehringer-ingelheim

DV-433. Interactive Data Analysis and Exploration with composR: See the Forest AND the Trees
Steve Wade, Jazz Pharmaceuticals
Sudhir Kedare, Jazz Pharmaceuticals
Matt Travell, Jazz Pharmaceuticals
Chen Yang, Chen Yang
Jagan Mohan Achi, Jazz Pharmaceuticals

DV-438. Exploring DATALINEPATTERNS, DATACONTRASTCOLORS, DATASYMBOLS, the SAS System® REGISTRY procedure, and Data Attribute Maps (ATTRMAP) to assign invariant attributes to subjects and arms throughout a project.
Kevin Viel, Navitas Data Sciences

DV-455. Reimagining reporting and Visualization during clinical data management
Vandita Tripathi, Ms
Manas Saha, TCS

DV-456. An introduction to Quarto: A Versatile Open-source Tool for Data Reporting and Visualization
Joshua Cook, University of West Florida (UWF)

DV-458. Quarto 1.4: Revolutionizing Open-source Dashboarding Capabilities
*** BEST PAPER ***
Joshua Cook, University of West Florida (UWF)
Kirk Paul Lafler, sasNerd



e-Posters

PO-106. No LEAD Function? Let's Create It!
Xianhua Zeng, Elixir Clinical Research

PO-123. Enhancing Define-XML Generation: Based on SAS Programming and Pinnacle 21 Community
Kevin Sun, HKU-CTC

PO-128. A Deep Dive into Enhancing SAS/GRAPH® and SG Procedural Output with Templates, Styles, Attributes, and Annotation
Louise Hadden, Abt Global Inc.

PO-129. The Survival Mode
Varsha Ganagalla, Innovative Analytics, Inc.
Natalie Johnson, Innovative Analytics, Inc.

PO-145. Integrity, Please: Three Techniques for One-Step Solution in Pharmaceutical Programming
Jason Su, SAS Inc.

PO-158. If its not broke, don't fix it; existing code and the programmers' dilemma
Jayanth Iyengar, Data Systems Consultants LLC

PO-194. Updates on Preparing a BIMO Data Package
Elizabeth Li, PharmaStat, LLC
Carl Chesbrough, PharmaStat, LLC
Inka Leprince, PharmaStat, LLC

PO-195. A Simple Way to Make Adaptive Pages in Listings and Tables
Yi Guo, Pfizer Inc.

PO-196. Comparing SAS® and R Approaches in Creating Multicell Dot Plots in Statistical Programming
Yi Guo, Pfizer Inc.

PO-231. Best Function Ever: PROC FCMP
Michael Stout, Johnson & Johnson Medical Device Companies

PO-258. An approach to make Data Validation and Reporting tool using R Shiny for Clinica Data Validation
Madhavi Gundu, Ephicacy
Vivek Jayesh Mandaliya, Ephicacy Lifesciences

PO-292. Elevate Your Game: Leveling Up SDTM Validation with the Magic of Data Managers
Julie Ann Hood, Pinnacle 21
Jennifer Manzi, Pinnacle 21

PO-299. Upholding Blinding in Clinical Trials: Strategies and Considerations for Minimizing Bias
Chen Li, Boehringer Ingelheim
Hong Wang, Boehringer Ingelheim
Ke Xiao, Boehringer Ingelheim

PO-324. Plotting Data by US ZIP Code
David Franklin, TheProgrammersCabin.com

PO-440. The SAS Genome - Genetic Sequencing
Oliver Lu, Eurofins Viracor
Katie Watson, Eurofins Viracor

PO-451. Simplifying Edit Check Configuration
*** BEST PAPER ***
Vandita Tripathi, Ms
Manas Saha, TCS



FDA Wednesday

FDA-G001. Standard Safety Tables & Figures (ST&F) Update
Y. Veronica Pei, MD, MEd, MPH, FACEP, Acting Lead Physician, CDER OND ODES BIRRS

FDA-G002. FDA Study Data Policy Framework and Recent Activities
Helena Sviglin, Data Standards Staff, Office of Strategic Policy, CDER



Hands-On Training

HT-101. Deep Dive into the BIMO (Bioresearch Monitoring) Package Submission
Mathura Ramanathan, IQVIA
Nancy Brucken, IQVIA

HT-111. A Gentle Introduction to SAS Packages
Bart Jablonski, yabwon

HT-118. The Art of Defensive SAS Programming
Philip Holland, Holland Numerics

HT-143. The New Shape Of SAS Code
Charu Shankar, SAS Institute

HT-152. GenAI to Enhance Your Statistical Programming
Phil Bowsher, RStudio Inc.

HT-157. Understanding Administrative Healthcare Datasets using SAS programming tools.
Jayanth Iyengar, Data Systems Consultants LLC

HT-197. Building Complex Graphics from Simple Plot Types
Dan Heath, SAS

HT-201. Transitioning from SAS to R
Ashley Tarasiewicz, Atorus Research
Chelsea Dickens, Atorus Research

HT-413. Complex Custom Clinical Graphs Step by Step with SAS® ODS Statistical Graphics
Richann Watson, DataRich Consulting
Josh Horstman, Nested Loop Consulting

HT-459. Hands-on Python PDFs: Using the pypdf Library To Programmatically Design, Complete, Read, and Extract Data from PDF Forms Having Digital Signatures
Troy Hughes, Datmesis Analytics



iConsult

IC-01. Entity Types - Which One to Choose?
Raymond Lee, Ray Information Systems
Margaret Hung, MLW Consulting LLC

IC-02. Show Me The Money! Promoting Your Consulting Business and Setting Your Rate
Joshua Horstman, Nested Loop Consulting

IC-03. Importance of the Small Business Tax Workshop
Veronica Tubman, IRS

IC-04. Ctrl + S(hare): A Programmer's Advice for Leveraging Social Media
Inka Leprince, PharmaStat, LLC

IC-05. Insight Into Issues and Accounting Methods
Athene Steinke, IRS

IC-06. The Pitfalls of Self-Employed Individuals
Christopher J. Williams, CPA, Kram, McCarthy, Ayers & Frost LLC

IC-07. Tax Breaks for the Average Joe/Jane
Margaret Hung, MLW Consulting LLC



Leadership Skills

LS-134. Recruiting Neurodivergent Candidates using the Specialisterne Approach
Patrick Grimes, Parexel

LS-167. Soft Skills to Gain a Competitive Edge in the 21st Century Job Market
Kirk Paul Lafler, sasNerd

LS-176. Effectively Manage the Programming Team Using MS Team
Jeff Xia, Merck
Simiao Ye, Merck & Co., Inc.

LS-286. Unlock Your Greatness: Embrace the Power of Coaching
Priscilla Gathoni, Wakanyi Enterprises Inc.

LS-304. Translation from statistical to programming: effective communication between programmers and statisticians
Diana Avetisian, IQVIA

LS-317. What Being a Peer-to-Peer Mentor Offers – Perspective from an Individual Project Level Contributor
LaNae Schaal, AstraZeneca

LS-335. Creating a Culture of Engagement – Role of a Manager
Monali Khanna, YPrime

LS-345. Leadership Lessons from Another Life: How my Previous Career Helped Me as a Statistician
*** BEST PAPER ***
Christiana Hawn, Catalyst Flex
Lily Ray, Catalyst Clinical Research

LS-351. A Framework for Risk-Based Oversight for Fully Outsourced Clinical Studies
Anbu Damodaran, Alexion Pharmaceuticals
Neha Srivastava, Fortrea

LS-357. Harmony in Motion: Nurturing Work-Life Balance for Sustainable Well-being
Purvi Kalra, Ephicacy
Varsha Patil, Ephicacy lifescience

LS-371. Go Get ‘Em: Manager's Guide to Make a Winning Business Proposal for Technology Solutions
Dilip Raghunathan, Regeneron

LS-383. Ongoing Trends and Strategies to Fine-tune the CRO/Sponsor Partnership – Perspectives from Statistical Programming
Mathura Ramanathan, IQVIA

LS-410. Adventures in Independent Consulting: Perspectives from Two Veteran Consultants Living the Dream
Josh Horstman, Nested Loop Consulting
Richann Watson, DataRich Consulting

LS-443. Data Harmony Revolution: Rocking Trials with Clinical Data Literacy
Melanie Hullings, TrialSpark
Andrew Burd, Formation Bio
Helena Belloff, Formation Bio
Emily Murphy, Formation Bio



Metadata Management

MM-225. Variable Subset Codelist
Kang Xie, AbbVie

MM-226. Methodology for Automating TOC Extraction from Word Documents to Excel
Jeetender Chauhan, Merck & Co., Inc.
Madhusudhan Ginnaram, Merck & Co., Inc., Rahway, NJ, USA
Sarad Nepal, Merck & Co., Inc., Rahway, NJ, USA
Jaime Yan, Merck & Co., Inc., Rahway, NJ, USA

MM-240. Managing a Single Set of SDTM and ADaM Specifications across All Your Phase 1 Trials
Avani Kaja, Pfizer

MM-245. Relax with Pinnacle 21's RESTful API
Trevor Mankus, Pinnacle 21

MM-267. A Practical Approach to Automating SDTM Using a Metadata-Driven Method That Leverages CRF Specifications and SDTM Standards
*** BEST PAPER ***
Xiangchen Cui, Crisprtx Therapeutics
Min Chen, CRISPR Therapeutics
Jessie Wang, CRISPR Therapeutics

MM-358. Optimizing Clinical Data Processes: Harnessing the Power of Metadata Repository (MDR) for Innovative Study Design (ISD) and Integrated Summary of Safety (ISS) / Efficacy (ISE)
Lakshmi Mantha, Ephicacy Life Sciences
Purvi Kalra, Ephicacy
Arunateja Gottapu, Mr

MM-447. Automating third party data transfer through digitized Electronic DTA Management
Vandita Tripathi, Ms
Manas Saha, Ms



Real World Evidence and Big Data

RW-125. Reconstruction of Individual Patient Data (IPD) from Published Kaplan-Meier Curves Using Guyot's Algorithm: Step-by-Step Programming in R
Ajay Gupta, Daiichi Sankyo
Natalie Dennis, Daiichi Sankyo

RW-227. A SAS® Macro Approach: Defining Line of Therapy Using Real-World Data in Oncology
Yu Feng, Merck

RW-275. Win a PS5! How to Run and Compare Propensity Score Matching Performance Across Multiple Algorithms in Five Minutes or Less
*** BEST PAPER ***
Catherine Briggs, SAS
Sherrine Eid, SAS Institute
Samiul Haque, SAS Institute
Robert Collins, SAS Institute

RW-390. Unraveling the Layers within Neural Networks: Designing Artificial and Convolutional Neural Networks for Classification and Regression Using Python's Keras & TensorFlow
Ryan Lafler, Premier Analytics Consulting, LLC
Anna Wade, Premier Analytics Consulting, LLC

RW-421. Applications of Machine Learning and Artificial Intelligence in Real World Data in Personalized Medicine for Non-Small Cell Lung Cancer Patients
Sherrine Eid, SAS Institute
Robert Collins, SAS Institute
Samiul Haque, SAS Institute

RW-450. Towards understanding Neurological manifestations of Lyme disease through a machine learning approach with patient registry data
Lorraine Johnson, LymeDisease.org
Lara Kassab, UCLA
Jingyi Liu, Colorado College
Deanna Needell, UCLA
Mira Shapiro, Analytic Designers LLC

RW-453. Interfacing with Large-scale Clinical Trials Data: The Database for Aggregate Analysis of ClinicalTrials.gov
Joshua Cook, University of West Florida (UWF)
Achraf Cohen, University of West Florida (UWF)



Solution Development

SD-141. "Prompt it", not "Google it" : Prompt Engineering for Statistical Programmers and Biostatisticians
Kevin Lee, Karuna Therapeutics

SD-165. Benefits, Challenges, and Opportunities with Open-Source Software Integration
Kirk Paul Lafler, sasNerd
Ryan Lafler, Premier Analytics Consulting, LLC
Joshua Cook, University of West Florida (UWF)
Stephen Sloan, Dawson D R

SD-166. The 5 CATs in the Hat – Sleek Concatenation String Functions
Kirk Paul Lafler, sasNerd

SD-179. Developing Web Apps in SAS Visual Analytics
Jim Box, SAS Institute
Samiul Haque, SAS Institute

SD-198. AutoSDTM Design and Implementation With SAS Macros
Chengxin Li, AutoCheng Clinical Data Services LLC

SD-200. Bridging AI and Clinical Research: A New Era of Data Management with ChatGPT
Illia Skliar, Intego Clinical

SD-211. Utility Macros for Data Exploration of Clinical Libraries
Matt Maloney, Bristol Myers Squibb

SD-217. Semi-Automated and Modularized Approach to Generate Tables for Clinical Study – Categorical Data Report
William Wei, Merck & Co, Inc.
Shunbing Zhao, Merck & Co.

SD-239. Automation of Report Generation Beyond Macro
Hong Qi, Merck & Co., Inc.
Mary Varughese, Merck & Co., Inc.

SD-243. Unravelling the SDTM Automation Process through the Utilization of SDTM Transformation Template
Lakshmi Mantha, Ephicacy Life Sciences
Inbasakaran Ramesh, Ephicacy Life Sciences

SD-255. Define-XML Conversion: A General Approach on Content Extraction Using Python
Danfeng Fu, MSD
Dickson Wanjau, Merck & Co., Inc.
Ben Gao, MSD

SD-262. Integration of SAS GRID environment and SF-36 Health Survey scoring API with SAS Packages
*** BEST PAPER ***
Bart Jablonski, yabwon

SD-266. A Tool for Automated Comparison of Core Variables Across ADaM Specifications Files
*** BEST PAPER ***
Amy Zhang, Merck & Co.
Huei-Ling Chen, Merck & Co.

SD-318. Streamlined EDC data to SDTM Mapping with Medidata RAVE ALS
Yunsheng Wang, ClinChoice
Erik Hansen, Clinichoice
Chao Wang, CliniChoice
Tina Wu, Clinichoice

SD-343. Two hats, one noggin: Perspectives on working as a developer and as a user of the admiral R package for creating ADaMs.
Benjamin Straub, GlaxoSmithKline

SD-356. Standardizing Validation Data Sets (VALDS) as matrices indexed by Page, Section, Row, and Columns (PSRC) to improve Validation and output creation and revisions.
Kevin Viel, Navitas Data Sciences

SD-365. Readlog Utility: Python based Log Tool and the First Step of a Comprehensive QC System
Zhihao Luo, Vertex Pharmaceuticals

SD-370. Enhancing FDA Debarment List Compliance through Automated Data Analysis Using Python and SAS
Yongjiang (Jerry) Xu, Genmab
Karen Xu, Northeastern University
Suzanne Viselli, Genmab

SD-397. Advancing Regulatory Intelligence with conversational and generative AI
Saurabh Das, Tata Consultancy Services
Rohit Kadam, Mr.
Rajasekhar Gadde, Mr.
Niketan Panchal, Mr.
Saroj Sah, Mr.

SD-401. Excel Email Automation Tool: Streamlining Email Creation and Scheduling
Xinran Hu, Merck
Jeff Xia, Merck

SD-412. Safety Signals from Patient Narratives PLUS: Augmenting Artificial Intelligence to Enhance Generative AI Value
Sherrine Eid, SAS Institute
Sundaresh Sankaran, SAS Institute

SD-426. Shift gears with 'gt': Finely tuned clinical reporting in R using "gt" and "gt summary" packages
Rajprakash Chennamaneni, Jazz Pharmaceuticals
Sudhir Kedare, Jazz Pharmaceuticals
Jagan Mohan Achi, Jazz Pharmaceuticals

SD-429. Build up Your Own ChatGPT Environment with Azure OpenAI Platform
Bill Zhang, ClinChoice Inc.
Jun Yang, ClinChoice Inc.

SD-431. inspectoR: QC in R? No Problem!
Steve Wade, Jazz Pharmaceuticals
Sudhir Kedare, Jazz Pharmaceuticals
Matt Travell, Jazz Pharmaceuticals
Chen Yang, Chen Yang
Jagan Mohan Achi, Jazz Pharmaceuticals

SD-444. 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
Troy Hughes, Datmesis Analytics



Statistics and Analytics

ST-113. Multiple Logistic Regression Analysis using Backward Selection Process on Objective Response Data with SAS®
Girish Kankipati, Seagen Inc
Jai Deep Mittapalli, Seagen Inc.

ST-164. Data Literacy 101: Understanding Data and the Extraction of Insights
Kirk Paul Lafler, sasNerd

ST-192. Generative Artificial Intelligence in sample size estimation - challenges, pitfalls, and conclusions
Igor Goldfarb, Accenture
Sharma Vikas, Accenture

ST-199. Demystifying Incidence Rates: A Step-by-Step Guide to Adverse Event Analysis for Novice Programmers
Yuting Peng, Amgen, Inc
Ruohan Wang, Amgen, Inc

ST-208. Bayesian Methods in Survival Analysis: Enhancing Insights in Clinical Research
Vadym Kalinichenko, Intego Group LLC

ST-251. Dealing with Missing Data: Practical Implementation in SAS and R
*** BEST PAPER ***
Isabella Wang, Eli Lilly & Co.
Jin Xie, Eli Lilly & Co.
Lauren George, Eli Lilly & Co.

ST-297. Relative Dose Intensity in Oncology Trials: A Discussion of Two Approaches
Christiana Hawn, Catalyst Flex
Dhruv Bansal, Catalyst Flex

ST-303. Source Data Quality Issues in PopPK/PD Dataset Programming: a Systematic Approach to Handle Duplicates
Ibrahim Priyana Hardjawidjaksana, SGS Health Science
Els Janssens, SGS Health Science
Ellen Winckelmans, SGS Health Science

ST-334. Versatile and efficient graphical multiple comparison procedures with {graphicalMCP}
Ethan Brockmann, Atorus Research
Dong Xi, Gilead Sciences, Inc.

ST-338. Bayesian Additive Regression Trees for Counterfactual Prediction and Estimation
Michael Lamm, SAS

ST-339. Bayesian Hierarchical Models with the Power Prior Using PROC BGLIMM
Fang Chen, SAS
Yi Gong, SAS

ST-366. MLNR or Machine Learning in R
Chuck Kincaid, Experis Business Analytics

ST-381. Opportunities and Challenges for R as an open-sourced solution for statistical analysis and reporting, from vendor's perspective
Peng Zhang, CIMS Global
Lizhong Liu, CIMS global
Tai Xie, CIMS Global

ST-414. Estimating Time to Steady State Analysis in SAS
Richard Moreton, Merck & Co., Inc., Rahway, NJ, USA
Lata Maganti, Merck

ST-425. iCSR: A Wormhole to Interactive Data Exploration Universe
Sudhir Kedare, Jazz Pharmaceuticals
Steve Wade, Jazz Pharmaceuticals
Chen Yang, Chen Yang
Matthew Travell, Jazz Pharmaceuticals
Jagan Mohan Achi, Jazz Pharmaceuticals

ST-461. Oncology ADaM Datasets Creation Using R Programming: A Comprehensive Approach
Ishwar Chouhan, Atorus Research



Strategic Implementation & Innovation

SI-136. Agile, Collaborative, Efficient (ACE): A New Perspective on Data Monitoring Committee Data Review Preparation
Ke Xiao, Boehringer Ingelheim

SI-140. A fear of missing out and a fear of messing up : A Strategic Roadmap for ChatGPT Integration at Company Level
*** BEST PAPER ***
Kevin Lee, Karuna Therapeutics

SI-160. LLM-Enhanced Training Agent for Statistical Programming
Jason Zhang, Merck
Jaime Yan, Merck

SI-185. The Role of the Blinded Programmer in Preparation of Data Monitoring Committee Packages (for Clinical Trials)
Binal Mehta, Merck & Co.
Patel Mukesh, Merck & Co INC

SI-189. Automating the annotation of TLF mocks Using Generative AI
Vidya Gopal, Astrazeneca

SI-190. Navigating Success: Exploring AI-Assisted Approaches in Predicting and Evaluating Outcome of Clinical Trials and Submissions
Ruohan Wang, Amgen, Inc
Chris Qin, AMGEN, INC

SI-230. Quality Assurance within Statistical Programming: A Systemic Way to Improve Quality Control
Todd Case, Vertex Pharmaceuticals
Margaret Huang, Vertex Pharmaceuticals, Inc.

SI-269. Validating R for Pharma - Streamlining the Validation of Open-Source R Packages within Highly Regulated Pharmaceutical Work
Juliane Manitz, EMD Serono
Anuja Das, Biogen
Antal Martinecz, Certara
Jaxon Abercrombie, Genentech
Doug Kelkhoff, Roche

SI-291. PHUSE Safety Analytics Working Group – Overview and Deliverables Update
Nancy Brucken, IQVIA
Mary Nilsson, Eli Lilly & Company
Greg Ball, ASAP Process Consulting

SI-319. A Change is Gonna Come: Maintaining Company Culture, Managing Time Zones, and Integrating Teams after a Global Acquisition
Lydia King, Catalyst Clinical Research

SI-346. aCRF Copilot: Pioneering AI/ML Assisted CRF Annotation for Enhanced Clinical Data Management Efficiency
Chaitanya Pradeep Repaka, AI Lens Tech Pvt Ltd
Santhosh Karra, TechData Service Company LLC

SI-362. SASBuddy: Enhancing SAS Programming with Large Language Model Integration
Karma Tarap, BMS
Nicole Thorne, BMS
Tamara Martin, BMS
Derek Morgan, Bristol Myers Squibb
Pooja Ghangare, Ephicacy

SI-391. Facilitating Seamless SAS-to-R Transition in Clinical Data Analysis: A Finetuned LLM Approach
Chaitanya Pradeep Repaka, AI Lens Tech Pvt Ltd
Santhosh Karra, TechData Service Company LLC

SI-408. Agile Sponsor Oversight of Statistical Programming Activities
Manuela Koska, Koska GmbH
Veronika Csom, Koska GmbH

SI-446. One size does not fit all: The need and art of customizing SCE and MDR for end users
Shilpa Sood, Ephicacy Consulting Group
Sridhar Vijendra, Ephicacy Consulting Group

SI-452. Embracing Diversity in Statistical Computing Environments: A Multi-Language Approach
Amit Javkhedkar, Ephicacy
Sridhar Vijendra, Ephicacy Consulting Group



Submission Standards

SS-132. BIMO Brilliance: Your Path to Compliance Resilience
Jai Deep Mittapalli, Seagen Inc.
Girish Kankipati, Seagen Inc

SS-133. Cultivating Success with Non-standard Investigator-sponsored Trial Data for FDA Submissions
Jai Deep Mittapalli, Seagen Inc.
Jinit Mistry, Seattle genetics
Venkatesulu Salla, Seagen

SS-137. Study Start Date - Let's Get it Right!
David Izard, Merck

SS-213. Is a Participation-Level ADaM Dataset a Solution for Submitting Integration Data to FDA?
Sandra Minjoe, ICON PLC

SS-263. Creating Adverse Event Tables using R and SASSY System
Vicky Yuan, Incyte Coperation

SS-290. Combine PDFs in Submission-ready Format Quick and Easy
Robin Wu, PTC Therapeutics
Lili Li, PTC Therapeutics
Steven Huang, PTC Therapeutics

SS-306. Leveraging SAS and Adobe Plug-in for CRF Bookmark Generation (Rave studies)
Swaroop Neelapu, Algorics, Inc

SS-311. How to generate a submission ready ADaM for complex data
Yilan Xu, Clinchoice
Hu Qu, Clinchoice
Tina Wu, Clinchoice

SS-333. Lead-in and extension trials, how we documented datapoint traceability
Hanne Ellehoj, Lundbeck
Veeresh Namburi, Lundbeck

SS-344. Piloting into the Future: Publicly available R-based Submissions to the FDA
Benjamin Straub, GlaxoSmithKline

SS-363. A Programmer's Insight into an Alternative to TQT Study Data Submission
*** BEST PAPER ***
Hiba Najeeb, Vertex Pharmaceuticals
Raghavender Ranga, Vertex Pharmaceuticals

SS-368. Design Considerations for ADaM Protocol Deviations Dataset in Vaccine Studies
Rashmi Gundaralahalli Ramesh, Merck and Co.
Jeffrey Lavenberg, Merck & Co., Inc .

SS-376. Experimenting with Containers and webR for Submissions to FDA in the Pilot 4
André Veríssimo, Appsilon
Ismael Rodriguez, Appsilon

SS-377. Challenges and Considerations When Building e-Submission SDTM Data Packages
Wei Duan, Moderna Therapeutics

SS-422. Submitting Patient-Reported Outcome Data in Cancer Clinical Trials- Guidance for Industry Technical Specifications Document
Flora Mulkey, US. FDA