San Francisco, California
May 14-17, 2023

Advanced Programming

AP-009. A Configuration File Companion: testing and using environment variables and options; templates for startup-only options initstmt and termstmt
Ronald Fehd, Fragile-Free Software

AP-015. Using SQL Dictionaries to Research the Global Symbol Table
Ronald Fehd, Fragile-Free Software

AP-021. Have a Date with ISO®? Using PROC FCMP to Convert Dates to ISO 8601
Richann Watson, DataRich Consulting

AP-026. A Quick Look at Fuzzy Matching Programming Techniques Using SAS® Software
Stephen Sloan, Accenture
Kirk Paul Lafler, sasNerd

AP-033. Twenty Ways to Run Your SAS® Program Faster and Use Less Space
Stephen Sloan, Accenture

AP-039. A utility to combine study outputs into all-in-one PDF for DSUR
Wei Shao, Bristol Myers Squibb

AP-048. Documenting your SAS programs with Doxygen and automatically generated diagrams.
Philip Mason, Wood Street Consultants

AP-049. Friends are better with Everything: A User's Guide to PROC FCMP Python Objects in Base SAS
Matthew Slaughter, Kaiser Permanente Center for Health Research
Isaiah Lankham, Kaiser Permanente Center for Health Research

AP-057. Best Practices for Efficiency and Code Optimization in SAS programming
Jayanth Iyengar, Data Systems Consultants LLC

AP-061. Going Command(o): Power(Shell)ing Through Your Workload
Richann Watson, DataRich Consulting
Louise Hadden, Abt Associates Inc.

AP-063. RESTful Thinking: Using R Shiny and Python to streamline REST API requests and visualize REST API responses
Laura Elliott, SAS Institute Inc.
Crystal Cheng, SAS Institute Inc.

AP-079. Using the R interface in SAS ® to Call R Functions and Transfer Data
*** BEST PAPER ***
Bruce Gilsen, Federal Reserve Board of Governors

AP-086. An Introduction to Obtaining Test Statistics and P-Values from SAS® and R for Clinical Reporting
Brian Varney, Experis

AP-090. Top 5 gotchas for getting cloud ready in SAS Viya
Charu Shankar, SAS Institute

AP-094. 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
Troy Hughes, Datmesis Analytics

AP-126. Facilitating Complex String Manipulations Using SAS PRX Functions
John LaBore, SAS Institute

AP-130. Strategies for Code Validation at Statistical Center for HIV/AIDS Research and Prevention (SCHARP)
Marie Vendettuoli, Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Center
Xuehan (Emily) Zhang, Statistical Center for HIV/AIDS Research and Prevention, Fred Hutch Cancer Center
Rodger Zou, Statistical Center for HIV/AIDS Research and Prevention, Fred Hutch Cancer Center

AP-151. Real Projects, Real Transition, Really Revolutionary – Transitioning to R for Biometrics Work
Danielle Stephenson, Atorus Research
Alyssa Wittle, Atorus Research
Rebekah Oster, Atorus Research

AP-189. You can REST easy validating Synthetic Data
Ben Howell, SAS
Ben Bocchicchio, SAS Institute

AP-191. Survival Methods for Crossover in Oncology Trials
Brian Mosier, EMB Statistcal Solutions

AP-218. Automation of Validation of QC Plan Entries and Managing SAS Programs
Venkatesh Nemalipuri, Vertex Pharamceuticals Inc
Ateet Shah, Vertex Pharmaceuticals Inc.

AP-252. Program It Forward! – Thinking Downstream when Coding
Frank Canale, SoftwaRx, LLC

AP-253. Creating The cxtf Native SAS Test Framework
Magnus Mengelbier, Limelogic AB

AP-259. No More Manual PDF Bookmarks! An Automated Approach to Converting RTF Files to a Consolidated PDF with Bookmarks
Tyler Plevney, Emanate Biostats, Inc.

AP-268. Display Layout Specifications to Flexibly Design and Generate Tables
Songgu Xie, Regeneron Pharmaceuticals
Michael Pannucci, Regeneron Pharmaceuticals
Toshio Kimura, Regeneron Pharmaceuticals

AP-291. 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
*** BEST PAPER ***
Troy Hughes, Datmesis Analytics

AP-309. Macro To Automate Crossover Review In Produced Outputs
Igor Goldfarb, Accenture
Ella Zelichonok, Naxion

Data Standards

DS-035. Sound SDTM, Sound ADaM – Orchestrating SDTM and ADaM Harmonization
Nancy Brucken, IQVIA
David Neubauer, IQVIA
Soumya Rajesh, IQVIA

DS-036. Why FDA Medical Queries (FMQs) for Adverse Events of Special Interest? Implementation and Case Study
Clio Wu, Chinook Therapeutics Inc.

DS-041. Leverage and Enhance CDISC TAUGs to Build More Traceability for and Streamline Development of Efficacy ADaM in Oncology Studies
Xiangchen Cui, Crisprtx Therapeutics

DS-051. The Phantom of the ADaM: adding missing records to BDS datasets
Anastasiia Drach, Intego Group LLC

DS-054. SDTM Variables You Might Forget About
Nadiia Pukhliar, Intego Group, LLC.
Dariia Tsyhanenko, Intego Group, LLC.
Iryna Kotenko, Intego Group

DS-062. From Sea to shining sea - End to End discussion on PR and LB data
Abraham Yeh, Bayer Pharma

DS-114. CDISC SDTM IG v3.4: Subject Visits
Ajay Gupta, Daiichi Sankyo

DS-125. Questionnaires in ADaM: ADSF36
Keith Shusterman, Reata
Megan O'Grady, Reata Pharmaceuticals, Inc.
Mario Widel, Reata Pharmaceuticals Inc.

DS-129. Have Meaningful Relationships: An Example of Implementing SDTM Special Purpose Data Set RELREC with a Many-to-Many Relationship
Kaleigh Ragan, Crinetics Pharmaceuticals
Richann Watson, DataRich Consulting

DS-148. Automation of the SDSP CBER Appendix for Vaccine Studies
Nicole Jones, Merck
Pritesh Solanki, Merck

DS-149. Integrated Trial Design Model Datasets?
Christine McNichol, Labcorp

DS-150. ADaM Design and Programming Standardization for Oncology Efficacy Endpoints Based on RECIST 1.1
*** BEST PAPER ***
Ellen Lin, Seagen Inc.
Matt Ness, Seagen Inc.
Yinghui Wang, Seagen Inc.

DS-157. Hard Coding: What is it? Why Does It Matter? What Should You Do When Faced With Such A Request?
Michael Nessly, ICON PLC

DS-161. Handling Anti-Drug Antibody (ADA) Data for Efficient Analysis
Sabarinath Sundaram, Seagen Inc
Johnny Maruthavanan, Seagen

Kristin Kelly, ICON
Michael Beers, Pinnacle 21

DS-193. Can We Do It Better? Real-Time Validation Of Sdtm Mapping Is Superior To Double Programming
Daniel Rolo, Bioforum The Data Masters
Bremer Louw, Bioforum The Data Masters

Data Visualization and Reporting

DV-024. Methods of a Fully Automated CONSORT Diagram Macro %CONSORT
Jeffrey Meyers, Regeneron Pharmaceuticals

DV-037. Divergent Nested Bar Plot and SAS Implementation
Brian Lin, Regeneron Pharmaceuticals
Weiming Du, Regeneron Pharmaceuticals
Toshio Kimura, Independent Consultant

DV-073. Ten Rules for Better Charts, Figures and Visuals
Kirk Paul Lafler, sasNerd

DV-116. Post-surgical opioid pain medications usage evaluation using SAS and Excel
Marek Solak, Pacira BioSciences Inc.

DV-134. Life Table Analysis for Time to First Event Onset
Abhinav Srivastva, Exelixis Inc

DV-190. Amazing Graph Series: Butterfly Graph Using SGPLOT and GTL
*** BEST PAPER ***
Tracy Sherman, Ephicacy
Aakar Shah, Acadia Pharmaceuticals Inc.

DV-226. The Flexible Ways to Create Graphs for Clinical Trial
Hong Zhang, Merck & Co
Kaijun Zhang, Merck

DV-256. Complementary Overlay – A Programmatic Approach to Figure Output Validation
Jesse Pratt, PPD, part of Thermo Fisher Scientific
Rayce Wiggins, PPD, part of Thermo Fisher Scientific

DV-287. Meta-Analysis in R
Lin Gu, Duke University

DV-310. Revolutionizing Statistical Outputs Validation: a Product Demonstration of Verify, an ML-powered Automation Solution Streamlining the Validation Process
Ilan Carmeli, Beaconcure


PO-018. Visualization for Success: Driving KPIs and Organizational Process Improvements via Portfolio-level Analytics
Philip Johnston, Pinnacle 21
Julie Ann Hood, Pinnacle 21

PO-067. Submission survival guidelines for Statistical Programmers
*** BEST PAPER ***
Mekhala Acharya, Takeda Pharmaceuticals
Katlyn Buff, Takeda Pharmaceuticals
Norihiko Oharu, Takeda Pharmaceuticals

PO-080. What PROC SQL can't handle while Data Step can?
Deming Li, Merck & Co., Inc

PO-089. Creating a Centralized Controlled Terminology Mapping Repository
Danny Hsu, Seagen
Shreya Chakraborty, Seagen

PO-119. Programmer's Perspective: Step into Awareness Regarding Clinical Trial Deliverables and Their Impact
Lyma Faroz, Seagen Inc.
Jinit Mistry, Seattle genetics

PO-143. Real Time Analytical Reporting Using OpenFDA
Shubhranshu Dutta, University of Rochester

PO-177. A model for sponsors to support independent operation of IDMCs in clinical trials.
Bhanu Bayatapalli, University of Thiruvalluvar at INDIA
Yiyi Chen, PhD in Biostatistics from University of Iowa

PO-258. Using R to Automate Clinical Trial Data Quality Review
Melanie Hullings, TrialSpark
Emily Murphy, TrialSpark
Derek Lawrence, TrialSpark
Michelle Cohen, TrialSpark
Andrew Burd, TrialSpark

PO-294. Data Doesn't Lie – Real Time Monitoring and Projecting on Clinical Trial Enrollment Progression
Wenjun He, EMMES

PO-296. Implementing Agile Methodologies: Using Trello™ to Generate and Optimize Kanban Boards for Recurring SAS Programming Tasks
Gina Boccuzzi, PROMETRIKA, LLC.
Patrick Dowe, PROMETRIKA, LLC.

PO-337. The Effect of Bethanechol on Tracheobronchomalacia in Infants
Chary Akmyradov, Arkansas Children's Research Institute

FDA Wednesday

FDA-G001. Advancing Premarket Safety Analytics
Dr. Yang Veronica Pei, Chief Medical Officer, CDER OND ODES DBIRBD

FDA-G002. OCS Update: OCS Clinical Services & the Traceability Assessment
Jesse Anderson, Lead Project Manager, CDER OTS OCS DRRR

FDA-G003. FDA’s Study Data Policy Framework and How CDISC Properties Are Evaluated for Inclusion
Helena Sviglin, Program Management Officer, CDER OSP DSS

FDA-G004. Experiences of CDER Statistical Analysts with NDA/BLA Reviews: Some Helpful Tips for Sponsors
Liping Sun, Statistician, CDER OTS OB DAI

Freelancers Forum

FF-001. Why Incorporate is Smart Business
Margaret Hung, MLW Consulting

FF-002. Comparison of My Experience Between an Independent Consultant and an Employee
Kriss Harris, WCG Clinical Endpoint Solutions

FF-003. Soft Skills to Master as a Freelance Consultant
Kirk Lafler, sasNerd

FF-004. Better Business Through Better Records
Alexa Lam, IRS

FF-005. Do's and Don'ts of Being an Independent Consultant
Raymond Lee, Ray Information Systems, Inc.

FF-006. How to Promote Yourself
Josh Horstman, Nested Loop Consulting

FF-007. Pros and Cons of Freelancing
Pradeep Bangalore, Cesta, Inc.

FF-008. Rate Setting
Josh Horstman, Nested Loop Consulting

FF-009. IRS Audits - How to Beat Them
Larry Pon, Pon & Associates

Hands-On Training

HT-042. Commit early, commit often! A gentle introduction to the joy of Git and GitHub
Isaiah Lankham, Kaiser Permanente Center for Health Research
Matthew Slaughter, Kaiser Permanente Center for Health Research

HT-093. 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
Troy Hughes, Datmesis Analytics

HT-105. Understanding Administrative Healthcare Datasets using SAS programming tools.
Jayanth Iyengar, Data Systems Consultants LLC

HT-250. Generating Clinical Graphs in SAS and R – A Comparison of the Two Languages
Kriss Harris, SAS Specialists Ltd.
Endri Elnadav, EE Statistical Analysis & Consulting

HT-265. Blastula for Communicating Clinical Insights with R via Email
Phil Bowsher, RStudio Inc.

HT-355. Introducing TFL Designer: Community Solution to Automate Development of Mock-up Shells and Analysis Results Metadata
Bhavin Busa, Independent

HT-356. Sas Sql 101
Charu Shankar, SAS Institute

HT-357. SAS Enterprise Guide: 8.x (What is new!)
Ajay Gupta, Daiichi Sankyo

HT-358. R package validation
(No paper available)
Magnus Mengelbier, Limelogic AB

Leadership Skills

LD-004. Are you a great team player?
Daryna Yaremchuk, Intego Group LLC

LD-028. Developing and running an in-house SAS Users Group
Stephen Sloan, Accenture

LD-038. The Interview Process: An Autistic Perspective
Laura Needleman, AstraZeneca

LD-056. Adventures in Independent Consulting: Perspectives from Two Veteran Consultants Living the Dream
Josh Horstman, Nested Loop Consulting
Richann Watson, DataRich Consulting

LD-095. Lessons Learned from a Retired SAS® Programmer
*** BEST PAPER ***
Carey Smoak, Retired

LD-104. Planning Your Next Career Move – Resume Tips for the Statistical Programmer
Sapan Patel, Merck
Lisa Pyle, Merck & Co., Inc.

LD-178. Practical Tips for Effective Coaching for Leaders and Managers in Organizations
Priscilla Gathoni, Wakanyi Enterprises Inc.

LD-196. What's the F in specialized people? Let's talk FSP - the models, variations, and what it takes to be successful
Kathy Bradrick, Catalyst Clinical Research, LLC
Ershlena McDaniel, Catalyst Clinical Research
Lisa Stetler, Catalyst Clinical Research

LD-215. Get a GPS to navigate your skills to find career purpose
Charu Shankar, SAS Institute
Lisa Mendez, Catalyst Clinical Research

Metadata Management

MM-040. Gear up the Metadata – Automating Patient Profile Generation, a Metadata Driven Programming Approach
Tanmay Khole, PTC Therapeutics
Aman Sharma, PTC Therapeutics
Lili Li, PTC Therapeutics
Durga Prasad Chinthapalli, PTC Therapeutics

MM-118. Masters of the Table Universe: Creating Table Shells Consistently and Efficiently Across All Studies
Michael Hagendoorn, Seagen Inc.
Ran Li, Seagen Inc.
Mimi Vigil, Seagen Inc.
Shan Yang, Seagen Inc.

MM-205. Automating SDTM: A metadata-driven journey.
Keith Hibbetts, Eli Lilly and Company

MM-206. Challenges with Metadata Repository System Implementation: A Sponsor's Perspective
Radhika Kale, Bristol Myers Squibb
Reema Baweja, Bristol Myers Squibb

MM-272. Traceability: Not just about Data
Rohit Nagpal, Kite Pharma, Inc
Kavitha Mullela, EXPERIS Solutions

MM-273. Better CDISC Standards with Metadata Programming
Sunil Gupta, Gupta Programming
Abhishek Dabral, Alkermes Inc

MM-315. Macro to Automate Creation and Sync of Shell Document and TOC
Karen Walker, Walker Consulting LLC
Jeff Cao, RealtimeCRO

MM-327. All You Need to Know about the New CDISC Analysis Results Standards!
*** BEST PAPER ***
Bhavin Busa, Independent
Bess LeRoy, CDISC
Richard Marshall, CDISC

Quick Programming Tips

QT-001. A SAS® Macro to Convert CSV files to SAS Datasets
Zemin Zeng, Sanofi
Bo Yuan, Sanofi

QT-020. A Macro to Identify Repeating SAS(r) BY Variables in a MERGE
Timothy Harrington, Navitas Data Sciences

QT-030. Running Parts of a SAS Program while Preserving the Entire Program
Stephen Sloan, Accenture

QT-044. Macro Code to Test Existence of Various Objects
Ronald Fehd, Fragile-Free Software

QT-046. Repetitive Analyses in SAS® – Use of Macros Versus Data Inflation and BY Group Processing
Brad Danner, IQVIA
Indrani Sarkar, IQVIA

QT-047. Confirmation of Best Overall Tumor Response in Oncology Clinical Trials per RECIST 1.1
Danyang Bing, ICON Clinical Research

QT-085. Tips to Read In and Output Excel Spreadsheets in SAS
Chao Su, Merck
Jaime Yan, Merck
Changhong Shi, Merck

QT-099. SAS Macro Design Considerations to Generate Subgroup Table and Forest Plot in Oncology Studies
Yizhuo Zhong, Merck
Christine Teng, Merck

QT-100. With a View to Make Your Metadata Function(al): Exploring the FMTINFO() Function
Louise Hadden, Abt Associates Inc.

QT-121. Smart Use of SAS Output System and SAS Macro for Statistic Test Selection
Mengxi Wang, University of Southern California

QT-152. A utility tool to assist with the setup of the startup environment for remote access
William Wei, Merck & Co, Inc.
Shunbing Zhao, Merck & Co.

QT-165. Running Python Code inside a SAS Program
Jim Box, SAS Institute

QT-175. Let the Data Drive it and set your hands free – A Macro to create indicators for Special Interest AEs
Yiwei Liu, Eli Lilly
Jameson Cai, Eli Lilly

QT-213. SAS Macro to Automate Programmer Status Sheet
*** BEST PAPER ***
Denise Rossi, PROMETRIKA
Assir Abushouk, PROMETRIKA

QT-222. A SAS® System Macro to Quickly Display Discrepant Values that are too Long for the COMPARE Procedure Output.
Kevin Viel, Navitas Data Sciences

QT-233. Put on the SAS® Sorting Hat and Discover Which Sort is Best for You!
Charu Shankar, SAS Institute
Louise Hadden, Abt Associates Inc.

QT-234. Using P21 Checks to Help Your DM Out!
Chad Fewell, Deciphera Pharmaceuticals
Jesse Beck, N/A

QT-236. 10 Quick Tips for Getting Tipsy with SAS
Lisa Mendez, Catalyst Clinical Research
Richann Watson, DataRich Consulting

QT-239. Taming the Large SAS® Dataset by Splitting it Up
David Franklin,

QT-263. R Tables via GT for Regulatory Submissions
Phil Bowsher, RStudio Inc.

QT-280. Are you planning to create/validate CDISC data set in R? Here is a step-by-step guide!
Ganeshchandra Gupta, Ephicacy Consulting Group

QT-314. Assign Character Values from Logical Expression with CHOOSEC
Joel Campbell, Advanced Analytics, Inc.

QT-336. How to generate questionnaire data compliance report
Phaneendhar Gondesi, Blueprint Medicines

Real World Evidence and Big Data

RW-050. Real World Evidence in Distributed Data Networks: Lessons from a Post-Marketing Safety Study
Matthew Slaughter, Kaiser Permanente Center for Health Research
John Dickerson, Kaiser Permanente Center for Health Research
Jennifer Kuntz, Kaiser Permanente Center for Health Research

RW-060. Exploring the spread of COVID-19 in the United States using unsupervised graph-based machine learning
*** BEST PAPER ***
Kostiantyn Drach, Intego Group
Iryna Kotenko, Intego Group

RW-113. Patient's Journey using Real World Data and its Advanced Analytics
Kevin Lee, Genpact

RW-154. Automating Non-Standard New Study Set Up with a SAS Based Work Process
Xingshu Zhu, Merck
Bo Zheng, Merck
Li Ma, Merck

RW-163. CMS VRDC - A simplified overview. What to expect in terms of data, system, code.
Zeke Torres, Code629

RW-322. Novel Applications of Real World Data in Clinical Trial Operations: Clinical Trial Feasibility
Sherrine Eid, SAS Institute
Samiul Haque, SAS Institute, Inc

RW-324. Novel Applications of Real World Data in Clinical Trials: External Control Arms
Sherrine Eid, SAS Institute
Samiul Haque, SAS Institute, Inc

Solution Development

SD-069. Application of Tipping Point Analysis in Clinical Trials using the Multiple Imputation Procedure in SAS
Yunxia Sui, AbbVie
Xianwei Bu, AbbVie

SD-070. Do it the smart way, renumber with PowerShell scripts!
Menaga Guruswamy Ponnupandy, Thermo Fisher Scientific

SD-072. Data Access Made Easy Using SAS® Studio
Kirk Paul Lafler, sasNerd
Shaonan Wang, Informatics Skunkworks
Nuoer Lu, UC San Diego Health
Zheyuan Walter Yu, Optimus Dental Supply
Daniel Qian, University of Washington

SD-082. Battle of the Titans (Part II): PROC REPORT versus PROC TABULATE
Kirk Paul Lafler, sasNerd
Josh Horstman, Nested Loop Consulting
Ben Cochran, The Bedford Group
Ray Pass, "Retired and Having the Time of His Life”
Dan Bruns, "Very Happily Retired”

SD-084. A Macro Utility for CDISC Datasets Cross Checking
Chao Su, Merck
Jaime Yan, Merck
Changhong Shi, Merck

SD-098. Introduction of Developing Resistance Dataset
Jenny Zhang, Merck & Co., Inc
Shunbing Zhao, Merck & Co.

SD-103. A SAS Macro to Perform Consistency Check in CSR Footnote References
Jeff Xia, Merck
Chandana Sudini, Merck

SD-109. Importance of Creating a Learning Portal for Statistical Programming End-to-End Processes
Yogesh Pande, Merck Inc.
Donna Hyatt, Merck & Co., Inc.
Brandy Cahill, Merck & Co., Inc.

SD-122. Building an Internal R Package for Statistical Analysis and Reporting in Clinical Trials: A SAS User's Perspective
*** BEST PAPER ***
Huei-Ling Chen, Merck & Co.
Heng Zhou, Merck & Co.
Nan Xiao, Merck & Co., Inc.

SD-167. Bringing it All Together: Applying the Analytics Life Cycle for Natural Language Processing to Life Sciences
Sundaresh Sankaran, SAS
Tom Sabo, SAS

SD-169. Effective APIs for SAS Language Applications
Randy Betancourt, Altair
Oliver Robinson, Altair

SD-183. Was the load okay?
Lisa Eckler, Lisa Eckler Consulting Inc.

SD-185. A Light-Weight Framework to Manage Programs and Run All the TLFs in R
Chi-Hua Huang, Astellas Pharma Global Development, Inc.

SD-207. Acceleration and automation of genomic data analysis to meet corporate compliance standards using advanced cloud components
Gopal Joshi, Senior Scientist
Satyoki Chatterjee, Project Manager
Pankaj Choudhary, Bioinformatics Analyst
Sanjay Koshatwar, Circulants
Shekhar Seera, Circulants

SD-221. SAS® System Macros to Summarize the COMPARE Procedure Results and SAS Logs for a Directory or Single File.
*** BEST PAPER ***
Kevin Viel, Navitas Data Sciences

SD-230. Automated Mockup Table and Metadata Generator
Jeff Cheng, Merck & Co., Inc.
Shunbing Zhao, Merck & Co.
Guowei Wu, Merck & Co., Inc.
Suhas Sanjee, Merck & Co., Inc.

SD-232. Tired of Manual Language Translation? Give it a REST!
Shawn Hopkins, Seagen Inc.
Matthew Ness, Seagen Inc.

SD-255. Using Bundles for R Package Management
Magnus Mengelbier, Limelogic AB

SD-257. Using R to Create Population Pharmacokinetic Dataset
Yangwei Yan, Bristol Myers Squibb
Prema Sukumar, Bristol Myers Squibb
Neelima Thanneer, Bristol Myers Squibb

SD-264. R Package Quality & Validation: Current Landscape
Phil Bowsher, RStudio Inc.

SD-270. Automating Data Validations with Pinnacle 21 Command Line Interface
Philipp Strigunov, Pinnacle 21

SD-300. Standardized data handling framework for wearables
Madhu Annamalai, Algorics
Umayal Annamalai, Algorics

SD-311. Exploring the use of AI-based image recognition and Machine Learning to Improve the Efficiency and Accuracy of TLFs Validation Process.
Mor Ram-On, Beaconcure
Ilan Carmeli, Beaconcure

SD-313. Be a Lazy Validator - Let Your Code Do the Work
Cara Lacson, Advance Research Associates, Inc
Ray de la Rosa, Advance Research Associates, Inc.
Carol Matthews, Advance Research Associates, Inc.

SD-325. Admiralonco – the cross-company R package for Oncology admirers
Neharika Sharma, GlaxoSmithKline Pharmaceuticals
Matthew Marino, GlaxoSmithKline Pharmaceuticals

SD-334. 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
Joshua Cook, Andrews Research & Education Foundation
Jessica Truett, Andrews Research & Education Foundation

SD-335. Low Code Approach to Clinical Application Development using SAS Studio Custom Step
David Olaleye, SAS Institute

Statistics and Analytics

SA-019. A Macro to Apply Exclusion Criteria to SAS(r) PK data
Timothy Harrington, Navitas Data Sciences

SA-068. Validating novel maraca plots – R and SAS love story
*** BEST PAPER ***
Nicole Major, AstraZeneca
Srivathsa Ravikiran, AstraZeneca
Monika Huhn, AstraZeneca
Samvel Gasparyan, AstraZeneca
Martin Karpefors, AstraZeneca

SA-092. Picking Scabs and Digging Scarabs: Refactoring User-Defined Decision Table Interpretation Using the SAS® Hash Object To Maximize Efficiency and Minimize Metaprogramming
Troy Hughes, Datmesis Analytics
Louise Hadden, Abt Associates Inc.

SA-110. Deep Learning to Classify Adverse Events from Patient Narratives
Tom Sabo, SAS
Sundaresh Sankaran, SAS
Qais Hatim, FDA

SA-166. What is Machine Learning, anyway?
Jim Box, SAS Institute

SA-188. Sensitivity Analysis for Missing Data Using Control-based Pattern Imputation
Jun Feng, Seagen Inc
Jingmin Liu, Seagen Inc.

SA-228. Shifting the drug development paradigm with Adaptive Design and master protocol

SA-269. Statistical Considerations and Methods for Handling Missing Outcome Data in Clinical Trials During the Era of COVID-19
Xi Qian, BioPier, Inc.
Chengfei Lu, BioPier, Inc.

SA-284. SAS-based Method for PK Noncompartmental Analysis and Validation
Hui Mao, Biopier Inc.
Lixin Gao, Biopier Inc

SA-285. Guidelines for the Statistical Analysis in German Dossier Submissions
Meiling Gao, Biopier Inc.
Xi Qian, BioPier, Inc.
Hui Mao, Biopier Inc.

SA-303. A Pain in My ISR - A Primer on Injection Site Reactions
Kjersten Offenbecker, GlaxoSmith Kline
Fox Mulder, GlaxoSmith Kline

Strategic Implementation & Innovation

SI-005. What's the story in your subgroup analysis
Lucy Dai, Abbvie

SI-006. Digital Data Flow (DDF) and Technological Solution Providers
Piyush Singh, TCS
Prasoon Sangwan, TCS

SI-016. Fitting Logitoid-Normal distributions with MLE estimate by SAS SEVERITY and FCMP procedures
Lili Huang, BMS
Helen Dong, BMS
Yuanyuan Liu, Bristol Myers Squibb

SI-055. We Can Work it Out: Dos and Don'ts for Small Biotech and CRO NDA/BLA submission partnership
Charity Quick, Rho, Inc.
Jiaan Illidge, Mersana

SI-088. Key Safety Assessments following Chimeric Antigen Receptor (CAR) T-cell Therapy in Early Development Oncology
Leanne Tenry, Bristol Myers Squibb
Tamara Martin, Bristol Myers Squibb
Olga Belotserkovsky, Presenter
Ce Zhou, Bristol Myers Squibb
Ouying (Abraham) Zhao, Techdata Service Company LLC

SI-102. Key Statistical Programming Considerations in External Collaborative Clinical Trials
James Zhao, Merck & Co., Inc
Hong Qi, Merck & Co., Inc.
Mary Varughese, Merck & Co., Inc.

SI-106. Automation of Dataset Programming Based on Dataset Specification
Liqiang He, Atara Biotherapeutics

SI-139. Integrating Practices: How Statistical Programmers Differ and Align Within User Groups
Valeria Duran, Statistical Center for HIV/AIDS Research and Prevention at Fred Hutch
Radhika Etikala, Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch
Haimavati Rammohan, Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch

SI-147. An End-to-End and Fully Integrated Clinical Development Platform with eDC/Labs data Data Management, Medical Review, Statistical Analysis and Adaptive Design etc.
Peter Wang, Johnson and Johnson
Vindyala Sunil, Janssen Research and Development

SI-159. SAS LOG/LST Filename improvement for easier: code review, code audit and project development history and chronology.
Zeke Torres, Code629

SI-164. Introduction of AWS Cloud Computing and its future for Biometric Department
Kevin Lee, Genpact

SI-170. The implementation of Scrum in Pharmaceutical Data Analytics and Statistical Programming
Jagan Mohan Achi, Jazz Pharmaceuticals
Eliana D'Angelo, Scimitar - consulting for Jazz Pharmaceuticals

SI-176. Tips and traps on how to efficiently accelerate clinical trials to successful submission, approval, and launch
*** BEST PAPER ***
Michael Nessly, ICON PLC

SI-202. Making Multilingual Programmers – A Targeted Approach to R for Clinical Trials Training
Jagan Mohan Achi, Jazz Pharmaceuticals
Ashley Tarasiewicz, Atorus Research

SI-212. R Package Qualification: Automation and Documentation in a Regulated Environment
Paul Bernecki, MSD
Nicole Jones, Merck
Uday Preetham Palukuru, MERCK
Abhilash Chimbirithy, Merck & Co.

SI-227. Metaverse in the Healthcare – More Real than imagined!

SI-235. Secret SAS - You Can Write eCTD Using ODS Word in SAS
Pete Lund, Looking Glass Analytics
Anusha Minnikanti, Fred Hutchinson Cancer Center
Calins Alphonse, Fred Hutchinson Cancer Center
Julie Stofel, Fred Hutchinson Cancer Center

SI-277. PHUSE Safety Analytics Working Group – Overview and Deliverables Update
Nancy Brucken, IQVIA
Clio Wu, Chinook Therapeutics Inc.
Mary Nilsson, Eli Lilly & Company
Greg Ball, ASAP Process Consulting

SI-302. Auto-validation of SAS Macros through Regression Testing
Madhu Annamalai, Algorics
Umayal Annamalai, Algorics

Submission Standards

SS-003. Handling CRS/NT Data in CAR-T Studies and Submission
Joe Xi, Bristol Myers Squibb
Yuanyuan Liu, Bristol Myers Squibb

SS-045. Optimizing Efficiency and Improving Data Quality through Meaningful Custom Fix Tips and Explanations
Jennifer Manzi, Pinnacle 21
Julie Ann Hood, Pinnacle 21

SS-059. CDISC Conformance and Compliance: So Many Resources, So Little Time!
Jennifer Fulton, Westat
Stephen Black, Westat

SS-097. Study Data Technical Rejection Criteria (TRC) Considerations for Multiple Data Packages in a Single Submission
Christine Teng, Merck
Si Ru Tang, Merck
Janet Low, Merck

SS-112. Standardization of Reactogenicity Data into Findings
Charumathy Sreeraman, Ephicacy Lifescience Analytics

SS-117. Consistency Checks Automation across Regulatory Submission Documents in the eCTD M5 folder
Majdoub Haloui, Merck & Co. Inc.
Loganathan Ramasamy, Merck & Co.,
Hemu Shere, Merck & Co.,

SS-124. How Can I Put This? - Using a pre-defined spreadsheet to explain your Pinnacle 21 Enterprise Issues
Mike Lozano, Eli Lilly and Company

SS-127. Proposal for New ADaM Paired Variables: PARQUAL/PARTYPE
Elizabeth Dennis, EMB Statistical Solutions, LLC
Monika Kawohl, mainanalytics GmbH
Paul Slagle, IQVIA

SS-140. Working with Biomedical Concepts and SDTM Dataset Specializations for Define-XML using SAS© Open CST
Lex Jansen, CDISC

SS-146. ADaM Datasets with Multiple Participations per Subject
*** BEST PAPER ***
Grace Fawcett, Syneos Health
Sandra Minjoe, ICON PLC
Elizabeth Dennis, EMB Statistical Solutions, LLC

SS-216. Regulatory Data Submission and CDISC Compliance: Sponsor and Vendor Collaboration Best Practices
Tabassum Ambia, Alnylam Pharmaceuticals, Inc

SS-217. BIMO Package: Challenges and Perspectives while keeping up with the upgrades in the BIMO Technical Conformance Guide and the BDRG Guidelines
Mathura Ramanathan, IQVIA
Sowmya Gabbula, IQVIA

SS-223. A case study of a successful RTOR submission and approval for Rylaze
Sudhir Kedare, Jazz Pharmaceuticals
Dilip Nalla, Jazz Pharmaceuticals
Kumud Kanneganti, Jazz Pharmaceuticals
Jagan Mohan Achi, Jazz Pharmaceuticals

SS-224. From FDA to PMDA submission: How to resolve CDISC non-compliance issues
Karin Steffensen, H. Lundbeck
Carina Brixval, H. Lundbeck

SS-261. Recent updates in BIMO Technical conformance guidance and use case scenario
Vaibhav Garg, Anlylam Pharmaceuticals
Sreedhar Bodepudi, Alnylam Pharmaceuticals

SS-266. Industry metrics for standards utilization and validation rules
Sergiy Sirichenko, Pinnacle 21

SS-274. F2: FAIR and Filing - Assessing Data Fitness for FAIR and Filing
Bidhya Basnet, Roche-Genentech
Dyuthi Yellamraju, Roche-Genentech

SS-276. Adopting the New Integrated Analysis Data Reviewer's Guide (iADRG)
Randi McFarland, Ephicacy Consulting Group, Inc.
Srinivas Kovvuri, ADC Therapeutics USA
Kiran Kumar Kundarapu, Merck & Co., Inc
Satheesh Avvaru, Alexion Pharmaceuticals, Inc.

SS-282. Handling of Vaccine SDTM Data for FDA CBER/OVRR Submission Compliance
Pragathi Mudundi, BioPier Inc.
Zhaoyu Xie, Biopier Inc.

SS-304. As Simple as Falling Off a Log?: An Unusual Case Study of Mapping Data into the SDTM DA (Drug Accountability) Domain