Virtual Event
May 24-27, 2021

Advanced Programming

AP-008. Don't send the Macros, send the Catalog! The SAS Macro Catalog: a perfect way to send your macros to the client without sharing the code.
Steve Black, Precision for Medicine

AP-018. A Quick Look at Fuzzy Matching Programming Techniques Using SAS Software
Stephen Sloan, Accenture
Kirk Paul Lafler, sasNerd

AP-020. Twenty Ways to Run Your SAS Program Faster and Use Less Space
Stephen Sloan, Accenture

AP-030. "Bored"-Room Buster Bingo - Create Bingo Cards Using SAS ODS Graphics
[Additional Materials (ZIP Archive)]
Richann Watson, DataRich Consulting
Louise Hadden, Abt Associates Inc.

AP-034. From %Let to %Local; Methods, Use, and Scope of Macro Variables in SAS Programming
Jayanth Iyengar, Data Systems Consultants LLC

AP-041. Laboratory Results in Relation to Concomitant Medications (CMs)
Scott Horton, United BioSource

AP-042. Survival Statistics with PROC LIFETEST and PROC PHREG: Pitfall-Avoiding Survival Lessons for Programmers
Yun (Julie) Zhuo, PRA Health Sciences

AP-048. Using Stata for handling CDISC compliant datasets and outputs
Tong Zhao, LLX Solutions, LLC
Jin Shi, LLX Solutions, LLC

AP-053. A SAS Macro to Generate Slim Version of Define for RTOR
Jeff Xia, Merck

AP-066. Dynamic macro using the convergence dataset to generate the Odds Ratio (OR), Risk Ratio (RR) and Risk Difference (RD) per SOC/PT using Genmod procedure
Jagadish Katam, Princeps

AP-067. Imputation for Missing Dosing Time in NONMEM PopPK Datasets
Shuqi Zhao, Merck & Co., Inc.

AP-071. An efficient method to review annotation and create bookmark for case report form (acrf.pdf) using SAS program, FDF files, excel and Javascript in Acrobat
Chen-Jung Wu, Firma Clinical Research

AP-088. Using SAS for Forest Plots in AMNOG Meta-Analysis Reporting
Jian-An Lu, Independent SAS Consultant
Jinwei Yuan, Vifor Pharma, Inc

AP-092. PROC IMPORT and more. Or: when PROC IMPORT just doesn't do the job.
David Horvath, PhilaSUG

AP-095. Lazy Programmers write Self-Modifying code OR Dealing with XML file Ordinals
[Additional Materials (ZIP Archive)]
David Horvath, PhilaSUG

AP-101. Re-pagination of ODS RTF Outputs to Automate Page Breaks and Minimize Splits Across Pages
Jeremy Gratt, Modular Informatics LLC
Aditya Tella, Seagen

AP-103. Developing SAS Macro to Find Subject's Latest Available Date from Entire Database
*** BEST PAPER ***
Raghava Pamulapati, Merck
Sandeep Meesala, Merck

AP-106. Bookdown and Blogdown: Deep dive of the R packages and components needed to create documentation and websites.
*** BEST PAPER ***
Benjamin Straub, GlaxoSmithKline

AP-117. Under the Hood: The Mechanics of Various SQL Query Optimization Techniques
Kirk Paul Lafler, sasNerd

AP-120. Programming Time Varying Concomitant Medication Covariates in NONMEM PopPK Dataset
Dan Xiao, Merck
Jing Su, Merck
Shuqi Zhao, Merck
Xiang Liu, Incyte Corporation

AP-131. An R Shiny Application: Validated Analysis Results Using R and SAS
Abu Zafar Mohammad Sami, mainanalytics GmbH

AP-132. 100% Menu Driven SAS Windows Batch Job Runner and Log Analyzer
Sathish Saravanan, Quartesian Research Private Limited
Kameswari Pindiprolu, Quartesian Research Private Limited

AP-151. Using PROC FCMP to Create Custom Functions in SAS
Keith Shusterman, Reata
Mario Widel, Reata Pharmaceuticals Inc.

AP-156. "Packages" in R for Clinical Data Analysis, Let's Demystify
Nagalakshmi Kudipudi, Quartesian Research Private Limited

AP-174. Overlay Graphs: A Powerful Tool to Visualize and Simplify Complex Data
Manasa Gangula, Cytel Inc.

AP-184. Thwarting Nasties
David Franklin,

AP-195. How to ingratiate yourself with the "old-timers"
Kirsty Lauderdale, Clinical Solutions Group
Kjersten Offenbecker, GSK

AP-199. Should I Wear Pants in the Portuguese Expanse? Automating Business Rules and Decision Rules Through Reusable Decision Table Data Structures that Leverage SAS Arrays
Troy Hughes, Datmesis Analytics
Louise Hadden, Abt Associates Inc.

AP-204. R Reproducibility Best Practices for Pharma
Phil Bowsher, RStudio Inc.
Sean Lopp, RStudio

AP-207. GCIG Criteria, Programming Makes It Easy
Liming Xie, BeiGene
Wei Wei, BeiGene

Applications Development

AD-002. Macro Development from Design to Implementation Applied to Occurrence Data Frequency Analysis
[Additional Materials (ZIP Archive)]
Chengxin Li, Regeneron Pharmaceuticals Inc.
Michael Pannucci, Regeneron Pharmaceuticals Inc.
Toshio Kimura, Regeneron Pharmaceuticals Inc.

AD-036. Annotating CRFs More Efficiently
Noory Kim, SDC
Bhagyashree Shivakumar, SDC

AD-054. How to Translate RTF Documents
Jundong Ma, Statistical Programming, Dizal Pharma

AD-060. A Diagnostic Report for SAS Submission Programs
Yang Gao, Merck & Co., Inc.
Christine Teng, Merck & Co., Inc.

AD-064. Harness analytical strengths: SAS, R, Python Web Services
Sandeep Juneja, SAS Institute Inc
Ben Bocchicchio, SAS Institute

AD-079. Analysis and Reporting in Regulated Clinical Trial Environment using R
Peikun Wu, Merck
Uday Preetham Palukuru, MERCK
Sarad Nepal, Merck
Yiwen Luo, Merck
Yilong Zhang, Merck & Co. Inc.

AD-100. A metadata driven approach to mock TFL generation
*** BEST PAPER ***
Anne Petersen, Novo Nordisk A/S
Cristina Boschini, Novo Nordisk A/S
Tobias Kröpelin, Novo Nordisk A/S

AD-109. Solution when Global Pandemic resurrects paper-based PROs creating collection headaches for Data Managers
Terek Peterson, YPrime
Hayley Jeffery, YPrime
Justin Jaeschke, YPrime

AD-112. An Application of Flexible Operation Page Number Positioning Method for RTF Outputs
WenHsuan Wu, Pharmaceutical Co., Ltd

AD-133. Archival Tool: Automation using PowerShell
Sumit Pratap Pradhan, SYNEOS HEALTH

AD-162. Generating Synthetic CDISC Clinical Trial Data.
Jose Lacal, NIHPO, Inc.

AD-164. R-Shiny based customized data viewer and search engine
Hrideep Antony, Syneos Health USA
Aman Bahl, Syneos Health

AD-168. Extracting Data Standards Metadata and Controlled Terminology from the CDISC Library using SAS with PROC LUA
Lex Jansen, SAS Institute Inc.

AD-175. The SASSY System: Making R Easier for SAS Programmers
David Bosak,

AD-176. Open-Source Development for Traditional Clinical Reporting
Mike Stackhouse, Atorus Research
Nathan Kosiba, Atorus Research

AD-179. Macro to Compare Titles and Footnotes in Produced TLF and Corresponding Shells
*** BEST PAPER ***
Igor Goldfarb, Accenture
Ella Zelichonok, Naxion

AD-185. Generating the Demographics and Adverse Event Tables Using Excel and VBA
David Franklin,

AD-205. Productionalizing Shiny Deployments
Phil Bowsher, RStudio Inc.
Sean Lopp, RStudio

Artificial Intelligence (Machine Learning)

AI-010. Integrating Digital Images for Ophthalmology Trials using Machine Learning Techniques for Image Analysis.
Shubhranshu Dutta, HCVSD

AI-012. Application to Automate Clinical Study Report Generation using AI
Farha Feroze, Symbiance Inc

AI-049. How I became a Machine Learning Engineer from a Statistical Programmer
*** BEST PAPER ***
Kevin Lee, Genpact

AI-140. Virtual human organs in clinical trails
Sumeet Subhedar, Covance

AI-163. Random Forest Machine Learning Application using R Shiny for Project Timeline Forecasting
Hrideep Antony, Syneos Health USA
Aman Bahl, Syneos Health

Data Standards

DS-014. CDISC ADaM Phases, Periods, and Subperiods: A Case Study
Jennifer Fulton, Westat

DS-033. Neoadjuvant and Adjuvant Oncology Clinical Trials and Considerations for Designing the Subject Level Analysis Dataset (ADSL)
Madhusudhan Papasani, Merck & Co., Inc.
Swathi Kotla, Merck & Co., Inc
Elisabeth Pyle, Merck & Co., Inc

DS-037. Creating Hyperlinks in SDTM Specifications
Carey Smoak, Aerotek

DS-080. When Should I Break ADaM Rules?
Sandra Minjoe, PRA Health Sciences

DS-081. Adding Rows to a BDS Dataset: When to Use DTYPE in Addition to Metadata
*** BEST PAPER ***
Sandra Minjoe, PRA Health Sciences

DS-102. ADaM-like Dataset: how to do big things in a short time
Oksana Mykhailova, Contract Research Organization Quartesian, Ukraine, Kyiv
Andrii Klekov, Quartesian

DS-130. Untangling the Knot - Implementing Analysis Results Standards (Using SAS)
Hansjörg Frenzel, PRA Health Sciences

DS-142. Biomedical Concepts - An Emerging CDISC Data Standard: A Stepwise Approach for Building a Library of Data Definitions
Kirsten Langendorf, S-cubed/A3Informatics
Johannes Ulander, S-cubed

DS-165. Validation of CDISC specifications using VALSPEC utility macro
Hrideep Antony, Syneos Health USA
Aman Bahl, Syneos Health

DS-172. Rescreened Subjects, Data Collection and Standard Domains Mapping
(No paper available)
Vamshi Matta, covance
Savithri Jajam, Covance
Lavanya Peddibhotla, covance

Data Visualization and Reporting

DV-040. Graphs Made Easy Using SAS Graph Template Language
Manohar Modem, Cytel
Bhavana Bommisetty, Vita Data Sciences

DV-061. Double Waterfall Plot Creation for Comparing Target Lesions Data
Anilkumar Anksapur, Merck & Co., Inc
Raghava Pamulapati, Merck

DV-078. Graphical Representation of Clinical Data using Heat Map Graph
Pavani Potuganti, Eliassen Group Biometrics and Data Solutions
Sree Nalluri, Eliassen Group Biometrics and Data Solutions

DV-082. Automated CONSORT Flow Diagram Generation by SAS Programming
Ryan Yu, Regeneron Pharmaceuticals Inc.

DV-086. Creating Patient Profiles Using SAS® Software: Proc Report & SAS ODS
Ballari Sen, Agios Pharmaceuticals,Inc.

DV-113. Data Visualization in Real World Data (RWD) and Health Economics Outcomes Research (HEOR) using (Statistical Analysis Software) SAS
Swapna Ambati, Outcomes Research Manager

DV-114. Customize and Beautify Your Kaplan-Meier Curves in Simple Steps
John Henderson, Abbott
Lili Li, Abbott

DV-115. Making Your SAS Results More Meaningful with Color
Kirk Paul Lafler, sasNerd

DV-187. Dressing Up your SAS/GRAPH and SG Procedural Output with Templates, Attributes and Annotation
*** BEST PAPER ***
Louise Hadden, Abt Associates Inc.

DV-188. Visually Exploring Proximity Analyses Using SAS PROC GEOCODE and SGMAP and Public Use Data Sets
Louise Hadden, Abt Associates Inc.

DV-192. Super Static SG Graphs
Kriss Harris, SAS Specialists Ltd.

DV-200. A Sassy Substitute to Represent the Longitudinal Data - The Lasagna Plot
Soujanya Konda, IQVIA Pvt Ltd


EP-004. Migration of SAS Data from Unix server to Linux server
Hengwei Liu, Daiichi Sankyo Inc

EP-013. Reduce Review Time: Using VB to Catch Spelling Errors & Blank Pages in TLFs
Corey Evans, LLX Solutions, LLC
Ting Su, LLX Solutions, LLC
Qingshi Zhou, LLX Solutions, LLC

EP-029. A Macro for Point Estimate and Confidence Interval of the Survival Time Percentiles
Hengwei Liu, Daiichi Sankyo Inc

EP-039. Data Visualization Using GANNO, GMAP and GREMOVE to Map Data onto the Human Body
Rui Huang, RegeneronPharmaceuticals
Toshio Kimura, Regeneron Pharmaceuticals
Jennifer McGinniss, Regeneron Pharmaceuticals

EP-057. Generating .xpt files with SAS, R and Python
*** BEST PAPER ***
YuTing Tian, Vertex
Todd Case, Vertex Pharmaceuticals

EP-070. First Time Creating a Submission Package? Don't Worry, We Got You Covered!
Lyma Faroz, Seattle Genetics

EP-077. Introducing and Increasing Compliance of Good Programming Habits
Alan Meier, Cytel

EP-085. Making Customized RTF Output with R Package r2rtf
Huei-Ling Chen, Merck
Heng Zhou, Merck & Co.
Madhusudhan Ginnaram, Merck
Yilong Zhang, Merck & Co. Inc.

EP-087. Make Your Life Easy! How SpotFire and SAS together can help with better Data Review and Data Quality
Raj Sharma, Fate Therapeutics

EP-105. Restriction of Macro Variable Length - Dynamic Approach to Overcome
Kalyani Telu, Uniformed Services University of the Health Sciences

EP-122. Interactive Clinical Dashboards using R Studio
Syam Prasad Chandrala, Allogene
Chaitanya Chowdagam, Ephiicacy

EP-123. Intelligent Axis Scaling in SAS plots: %IAS
Sidian Liu, Genentech Inc,
Toshio Kimura, Regeneron Pharmaceuticals

EP-124. No Black Boxes: An Utterly Transparent Batch Randomization System in R
Dennis Sweitzer, YPrime

EP-143. Customizing define.xml files
Steffen Müller, mainanalytics GmbH

EP-146. e-Submissions key difference of FDA and PMDA
*** BEST PAPER ***
Giri Prasad, Covance Pvt ltd
Hareeshkumar Gurrala, Covance pvt ltd

EP-157. Fast, Efficient, and Automated Real-time Analytics for Clinical Trials
Aditya Gadiko, MMS Holdings
Christopher Hurley, MMS Holdings
Anish Iyer, MMS Holdings

EP-167. Forward Planning: How to get the most of your eCOA data
Frank Menius, YPrime
Monali Khanna, YPrime

EP-178. Containers you can Count On: A Framework for Qualifying Community Container Images
Eli Miller, Atorus Research

EP-182. Mashing Two Datasets Together
David Franklin,

EP-190. Looking for the Missing(ness) Piece
Louise Hadden, Abt Associates Inc.

EP-191. Only Get What You Need - To Simplify Analysis Data Validation Report from PROC COMPARE Output
Wenjun He, The Emmes Company, LLC

FDA Tuesday

FDA-001. Biomedical Informatics and Safety Analytics in the Office of New Drugs, CDER/FDA – A 2021 Update (slides)
Vaishali Popat, FDA CDER/OND

FDA-002. Collaborative Review of CDISC QRS Instruments (slides)
Steve Wilson, FDA CDER/OTS
Steve Kopko, CDISC
Dana Booth, CDISC

FDA-003. Updates from the Office of Biostatistics Analytics and Informatics Staff: Initiatives and Projects (slides)
Matilde Kam, FDA CDER/OTS
Xiaofeng (Tina) Wang, FDA CDER/OTS

FDA-004. Submitting Scientific Data from Different Sources (slides)

FDA-005. FDA Study Data Technical Rejection Update (slides)
Ethan Chen, FDA CDER/OSP

FDA-006a. SEND for CBER (slides)

FDA-006b. Global Vaccine Minimum Dataset (slides)
Gabriela Lopez Mitnik, FDA CBER/OD

FDA-006c. OBE update in CDISC (slides)
Jiang (Jessica) Hu, FDA CBER/OD

FDA-007. Policy Frameworks for Submitting Study Data to FDA (slides)
Helena Sviglin, FDA CDER/OSP

Hands-On Training

HT-009. Understanding Administrative Healthcare Datasets using SAS programming tools
Jayanth Iyengar, Data Systems Consultants LLC

HT-118. Essential Programming Techniques Every SAS User Should Learn
Kirk Paul Lafler, sasNerd

HT-127. Mitigating Multicollinearity: Using Regulation Techniques to Minimize the Effect of Collinearity
Deanna Schreiber-Gregory, Henry M Jackson Foundation for the Advancement of Military Medicine

HT-197. Yo Mama is Broke Cause Yo Daddy is Missing: Autonomously and Responsibly Responding to Missing or Invalid SAS Data Sets Through Exception Handling Routines
Troy Hughes, Datmesis Analytics

HT-206. R & Python for Drug Development
Phil Bowsher, RStudio Inc.
Sean Lopp, RStudio

HT-210. Machine Learning Programming Workshop - Natural Language Processing (NLP)
Kevin Lee, Genpact

HT-212. SAS Macro Efficiencies
Charu Shankar, SAS Institute

HT-214. Integrating SAS® and Microsoft Excel: Exploring the Many Options Available to You
Vince DelGobbo, SAS

Leadership Skills

LS-093. Why Data Scientists need leadership skills? Story of Cross-Value Chain Data Utilization Project
Yura Suzuki, Shionogi & Co., Ltd.
Yuichi Koretaka, Shionogi & Co., Ltd.
Ryo Kiguchi, Shionogi & Co., Ltd.
Yoshitake Kitanishi, Shionogi & Co., Ltd.

LS-116. Differentiate Yourself
Kirk Paul Lafler, sasNerd

LS-148. How to handle decision making in the CRO / sponsor relationship in matters that require expertise
Sarah McLaughlin, Sumitomo Dainippon Pharma Oncology

LS-152. Virtual Recruitment and Onboarding of Mapping Programmers during Covid 19- Merck's RaM Mapping Experience
Srinivasa Rao Mandava, Merck

LS-193. Leadership and Programming
*** BEST PAPER ***
Kriss Harris, SAS Specialists Ltd.

LS-194. Managing Transitions so Your Life is Easier
Kirsty Lauderdale, Clinical Solutions Group

Medical Devices

MD-035. ADaM Implementation Guide for Medical Devices
Julia Yang, Medtronic plc
Silvia Faini, LivaNova
Karin LaPann, PRA International

MD-038. Types of Devices in Therapeutic Area User Guides
*** BEST PAPER ***
Carey Smoak, Aerotek

MD-044. Multiple Successful Submissions of Medical Device Clinical Trial Data in the US and China using CDISC
Phil Hall, Edwards Lifesciences
Tikiri Karunasundera, Edwards Lifesciences
Subendra Maharjan, Edwards Lifesciences
Vijaya Vegesna, Edwards Lifesciences

Quick Tips

QT-007. How to Write a SAS Open Code Macro to Achieve Faster Updates
Frederick Cieri, Consultant

QT-021. Running Parts of a SAS Program while Preserving the Entire Program
Stephen Sloan, Accenture

QT-026. From SAS Dataset to Structured Document
Hengwei Liu, Daiichi Sankyo Inc

QT-027. What Kind of WHICH Do You CHOOSE to be?
*** BEST PAPER ***
Richann Watson, DataRich Consulting
Louise Hadden, Abt Associates Inc.

QT-065. Unnoticed individual and mean line plot issue while using the SGPLOT procedure and the solution to avoid
Jagadish Katam, Princeps

QT-069. Writing Out Your SAS Program Without Manually Writing it Out- Let Macros Do the Busy Work
Mindy Wang, Independant Consultant

QT-075. Shiny decisions - An R-shiny application for decision frameworks
Lasse Nielsen, Novo Nordisk

QT-096. NOBS for Noobs
David Horvath, PhilaSUG

QT-098. Wildcarding in Where Clauses
David Horvath, PhilaSUG

QT-111. A Unique Way to Identify the Errors in SDTM Annotations Using SAS
*** BEST PAPER ***
Xingxing Wu, Eli Lilly and Company
Bala Dhungana, Eli Lilly and Company

QT-129. Easing the Process of Creating CRF Annotations
Samadi Karunasundera, University of California, Berkeley
Jun Wang, Edwards Lifescience

QT-134. Using Regex to Parse Attribute-Value Pairs in a Macro Variable
Rowland Hale, Syneos Health

QT-139. Common Dating in R: With an example of partial date imputation
Teckla Akinyi, GSK

QT-147. Overcoming the Challenge of SAS Numeric Date Comparisons
Shikha Sreshtha, Covance by Labcorp

QT-159. Manage SAS Log in Clinical Programming
Yuping Wu, PRA Health Science

QT-161. "Who wrote this!?" Challenges of replacing Black Box software with more dynamic supportable processes utilizing Open-Source Languages
Frank Menius, YPrime
Monali Khanna, YPrime
Terek Peterson, YPrime
Dennis Sweitzer, YPrime

QT-186. Where's Waldo? An SDTM Crawler
Derek Morgan, Clinical Solutions Group

QT-189. Management of Metadata and Documentation When Your Data Base Structure is Fluid: What to Do if Your Data Dictionary has Varying Number of Variables
Louise Hadden, Abt Associates Inc.

Real World Evidence and Big Data

RW-063. Generating FDA-ready Submission Datasets directly from EHRs
Jozef Aerts, XML4Pharma

RW-126. A Programmer's Experience Researching Real-World Evidence (RWE) COVID-19 Data
Ginger Barlow, UBC

RW-136. IOT or IOMT?
Lekitha Jk, Covance Clinical Development Pvt. Ltd.

RW-160. Patient Registries - New Gold Standard for Real World Data
Neha Srivastava, Covance
Lavanya Peddibhotla, Covance
Sivasankar Konda, Covance

RW-198. Better to Be Mocked Than Half-Cocked: Data Mocking Methods to Support Functional and Performance Testing of SAS Software
Troy Hughes, Datmesis Analytics

RW-202. NHANES Dietary Supplement component: a parallel programming project
Jayanth Iyengar, Data Systems Consultants LLC

RW-208. Life After Drug Approval... What Programmers Need to Know About REMS
Cara Lacson, United BioSource Corporation
Carol Matthews, Advance Research Associates, Inc.

RW-209. Standardizing Laboratory Data From Diverse RWD to Enable Meaningful Assessments of Drug Safety and Effectiveness
*** BEST PAPER ***
Irene Cosmatos, UBC
Michael Bulgrien, UBC

Statistics and Analytics

SA-032. Back to Basics: Running an Analysis from Data to Refinement in SAS
*** BEST PAPER ***
Deanna Schreiber-Gregory, Henry M Jackson Foundation for the Advancement of Military Medicine

SA-043. Visualization of Sparse PK Concentration Sampling Data, Step by Step (Improvement by Improvement)
Ilya Krivelevich, Eisai Inc.
Simon Lin, Eisai

SA-047. Build a model: Introducing a methodology to develop multiple regression models using R in oncology trial analyses
Girish Kankipati, Seagen Inc
Jai Deep Mittapalli, Seagen Inc

SA-062. SAS Proc Mixed: A Statistical Programmer's Best Friend in QoL Analyses
Janaki Devi Manthena, Seagen Inc.
Varsha Korrapati, Seagen Inc.
Chiyu Zhang, Seagen Inc

SA-138. Willing to Play with William's Design: An Exemplification of Randomization Schedule Generation using SAS
Abhyuday Chanda, Quartesian Research Private Limited

SA-141. BAYESIAN Approach on COVID-19 test results
Vidya Srinivas, Covance Clinical Development Pvt Ltd
Ankita Sharma, Covance Clinical Development Pvt Ltd

SA-145. Preserving the Privacy of Participants' Data by Data Anonymization
Chaithanya Velupam, Bangalore
Kaushik Sundaram, Covance

SA-155. Evaluating anthropometric growth endpoints with Z-Scores and Percentiles
Snehal Sanas, Covance Clinical Development Pvt Ltd
Pradeep Umapathi, Covance Clinical Development Pvt Ltd

SA-211. How simulation will impact the future of Healthcare & Life Sciences.
Lois Wright, SAS Institute Inc
Allison Sealy, SAS Institute Inc
Bahar Biller, SAS Institute Inc
Shawn Tedman, SAS Institute Inc
Pritesh Desai, SAS Institute Inc

Strategic Implementation

SI-019. Advanced Project Management beyond Microsoft Project, Using PROC CPM, PROC GANTT, and Advanced Graphics
Stephen Sloan, Accenture
Lindsey Puryear, SAS Institute

SI-028. A TransCelerate Initiative - how can you modernize your statistical environment?
Vincent Amoruccio, Pfizer
Min Lee, Transcelerate
Daniel Woodie, Merck

SI-046. PROC FUTURE PROOF v1.1-- Linked Data
*** BEST PAPER ***
Amy Gillespie, Merck & Co., Inc.
Susan Kramlik, Merck & Co., Inc.
Suhas Sanjee, Merck & Co., Inc.

SI-068. Lesson learned from a successful FDA Oncology Drug Advisory Committee (ODAC) meeting
Weiwei Guo, Merck
Chintan Pandya, Merck & Co.
Christine Teng, Merck

SI-074. A Strategy to Develop Specification for R Functions in Regulated Clinical Trial Environments
Aiming Yang, Merck & Inc
Yalin Zhu, Merck & Inc
Yilong Zhang, Merck & Inc.

SI-076. The Search for a Statistical Computing Platform
Susan Kramlik, Merck & Co., Inc.
Eunice Ndungu, Merck & Co., Inc.
Hemu Shere, Merck & Co., Inc.

SI-083. Agile Project Management in Analysis and Reporting of Late Stage Clinical Trial
Sarad Nepal, Merck
Uday Preetham Palukuru, MERCK
Peikun Wu, Merck
Madhusudhan Ginnaram, Merck
Ruchitbhai Patel, Merck
Abhilash Chimbirithy, Merck & Co.

SI-084. A Process to Validate Internal Developed R Package under Regulatory Environment
Madhusudhan Ginnaram, Merck
Amin Shirazi, Merck
Simiao Ye, Merck & Co., Inc.
Yalin Zhu, Merck
Yilong Zhang, Merck & Co. Inc.

SI-108. Bookdown and Blogdown: Using R packages to document and communicate new processes to Clinical Programming
Benjamin Straub, GlaxoSmithKline

SI-166. Delight the Customer using agile transformation in Clinical Research
Aman Bahl, Syneos Health
Steve Benjamin, Syneos Health
Hrideep Antony, Syneos Health USA

SI-173. The Tortoise and the Hare - Lessons Learned in Developing ADaM Training
Alyssa Wittle, Covance, Inc.

SI-196. Chasing Master Data Interoperability: Facilitating Master Data Management (MDM) Through CSV Control Tables that Contain Data Rules that Support SAS and Python Data-Driven Software Design
Troy Hughes, Datmesis Analytics

SI-203. R Validation: Approaches and Considerations
Phil Bowsher, RStudio Inc.
Sean Lopp, RStudio

SI-213. Manage TFLs Development in LSAF 5.3 using SAS and R code
Stijn Rogiers, SAS
Jean Marc Ferran, Qualiance

Submission Standards

SS-016. Design ADaM Specification Template that Simplifies ADaM Programming and Creation of Define XML in CDISC Era
Xiang Wang, Bristol-Myers Squibb
Daniel Huang, Bristol-Myers Squibb

SS-055. BIMO SAS Macros and Programming Tools
Mi Young Kwon, Regeneron, Inc.
Rohit Kamath, Regeneron, Inc.

SS-058. Shiny App for Generating Data Dependency Flowchart in ADRG
Simiao Ye, Merck & Co., Inc.
Yilong Zhang, Merck & Co. Inc.

SS-072. Challenges and Solutions for an ISM Development
Siru Tang, MSD
Yanhong Li, MSD

SS-073. New Requirements of Clinical Trial Data Submission for China Filing: An Implementation
Yuan Yuan Dong, MSD
Wang Zhang, MSD
Lili Ling, MSD

SS-110. Assembling Reviewer-friendly eSubmission Packages
*** BEST PAPER ***
Shefalica Chand, Seattle Genetics, Inc.

SS-137. Effective Approach for ADaM Submission to FDA and PMDA
Ranvir Singh, Mr.

SS-171. A Lead Programmer's Guide to a Successful Submission
Pranav Soanker, Covance
Santosh Shivakavi, SCL IT Technologies