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, TheProgrammersCabin.com
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, r-sassy.org
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, TheProgrammersCabin.com
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 StudyJennifer 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 LanguageManohar 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
ePosters
EP-004. Migration of SAS Data from Unix server to Linux serverHengwei 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, TheProgrammersCabin.com
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)
Fang Li, FDA CDER/OTS
FDA-005. FDA Study Data Technical Rejection Update (slides)
Ethan Chen, FDA CDER/OSP
FDA-006a. SEND for CBER (slides)
Lisa Lin, FDA CBER/OD
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 toolsJayanth 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 ProjectYura 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 DevicesJulia 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 UpdatesFrederick 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 EHRsJozef 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 GraphicsStephen 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 EraXiang 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