Austin, Texas
May 22-25, 2022
Advanced Programming
AP-019. From %let To %local; Methods, Use, And Scope Of Macro Variables In Sas ProgrammingJayanth Iyengar, Data Systems Consultants LLC
AP-025. Twenty Ways to Run Your SAS® Program Faster and Use Less Space
Stephen Sloan, Accenture
AP-030. A Quick Look at Fuzzy Matching Programming Techniques Using SAS® Software
*** BEST PAPER ***
Stephen Sloan, Accenture
Kirk Paul Lafler, sasNerd
AP-038. Fast hashes for complex joins
Bartosz Szymecki, Syneos Health
AP-041. Look Up Not Down: Advanced Table Lookups in Base SAS
Jayanth Iyengar, Data Systems Consultants LLC
Josh Horstman, Nested Loop Consulting
AP-072. SAS Standard Programming Practices – Handy Tips for the Savvy Programmer
Navneet Agnihotri, Syneos Heath
Sumit Pradhan, Syneos Health
Rachel Brown, Syneos Health
AP-081. A Programmer’s Perspective on Patient reported Outcomes in Oncology Trials
Divya Vemulapalli, Statistical Programmer
AP-083. Pharmacokinetics Concentration Data Deciphered – Presenting an Oncology Case Study
Nikita Sathish, Seattle Genetics
AP-107. Macro for Working with Zip Transport Files from the Web: The Case of the Medical Expenditure Panel Survey
Pradip Muhuri, DHHS/AHRQ
AP-108. From Codelists to Format Library
Nancy Brucken, IQVIA
AP-111. Functions (and More!) on CALL!
Louise Hadden, Abt Associates Inc.
Richann Watson, DataRich Consulting
AP-125. ISO 8601 and SAS®: A Practical Approach
Derek Morgan, Bristol Myers Squibb
AP-146. Merging Pharmacokinetic (PK) Sample Collection and Dosing Information for PK Analysis based on Study Design and lessons learned
Durga Kalyani Paturi, Senior Programmer Analyst
AP-171. Self Modifying Macro to Automatically Repeat a SAS Macro Function
*** BEST PAPER ***
Chary Akmyradov, Arkansas Children's Research Institute
AP-180. Putting the Meta into the Data: Managing Data Processing for a Large Scale CDC Surveillance Project with SAS®
(No paper available)
Louise Hadden, Abt Associates Inc.
AP-183. Calling for Backup When Your One-Alarm Becomes a Two-Alarm Fire: Developing SAS® Data-Driven Concurrent Processing Models through Control Tables and Dynamic Fuzzy Logic
Troy Hughes, Datmesis Analytics
AP-188. Pins for Sharing Clinical R Assets
(No paper available)
Phil Bowsher, RStudio Inc.
AP-189. Quarto for Creating Scientific & Technical Documents
(No paper available)
Phil Bowsher, RStudio Inc.
Ryan Johnson, RStudio
AP-193. R syntax for SAS programmers
Max Cherny, GlaxoSmithKline
Applications Development
AD-001. ADCM Macro Design and ImplementationChengxin Li, Regeneron
Tingting Tian, Regeneron Pharmaceuticals Inc.
Toshio Kimura, Regeneron Pharmaceuticals Inc.
AD-027. Running Parts of a SAS Program while Preserving the Entire Program
Stephen Sloan, Accenture
AD-036. Reconstruction of survival curves: An approach of comparing study drug curve with the standard of care digital survival curve
Girish Kankipati, Seagen Inc
Jai Deep Mittapalli, Seagen Inc.
AD-045. How to create SDTM SAS transport datasets using Python
Kevin Lee, Genpact
AD-059. Evaluating and Correcting Nominal and Actual Relative Time Measurements in Clinical Trials PK data
Timothy Harrington, Navitas Data Sciences
AD-062. A Multilingual Shiny App for Drug Labelling in Worldwide Submission
Aiming Yang, Merck & Co.
Jinchun Zhang, Merck & Co., Inc
Yiwen Luo, Merck & Co., Inc
Nan Xiao, Merck & Co., Inc
Yilong Zhang, Merck & Co., Inc
AD-069. A Shiny App to Spell Check an ADaM Specification
Simiao Ye, Merck & Co.
Jeff Xia, Merck & Co.
AD-076. Exploring R as a validation tool for statistical programming in clinical trials
*** BEST PAPER ***
Uday Preetham Palukuru, Merck & Co.
Runcheng Li, MERCK
Nileshkumar Patel, MERCK
Changhong Shi, MERCK
AD-084. A SAS Macro to Aid Assembly Review of M5 Module in Submission
Jeff Xia, Merck & Co.
AD-115. Checking Compliance of CDISC SDTM Datasets Utilizing SAS Procedures.
Ballari Sen, Bristol Myers Squibb
AD-122. Automatic CRF Annotations Using Python
Lijun Chen, LLX Solutions, LLC
Jin Shi, LLX Solutions, LLC
Tong Zhao, LLX Solutions, LLC
AD-131. SAS Macro to Colorize and Track Changes Between Data Transfers in Subject-Level Listings
Inka Leprince, PharmaStat, LLC
Elizabeth Li, PharmaStat, LLC
Carl Chesbrough, PharmaStat, LLC
AD-145. Optimizing TLF Generation: Titles and Footnotes Applying a New Idea to a Basic Approach
Jake Adler, PROMETRIKA
Assir Abushouk, PROMETRIKA
AD-150. Working with Dataset-JSON using SAS©
*** BEST PAPER ***
Lex Jansen, CDISC
AD-155. Connecting SAS® and Smartsheet® to Track Clinical Deliverables
Greg Weber, Navitas Data Sciences
Steve Hege, Alexion
Siddharth Kumar, Navitas Life Sciences
AD-167. Using the SAS System® with the National Center for Biotechnology Information resources and Immune Epitope Database to explore the realm of potential SARS-CoV-2 variants.
Kevin Viel, Histonis, Incorporated
AD-170. Using the SAS System® to interface with the Entrez Programming Utilities (E-utilities) of the National Center for Biotechnology Information (NCBI).
Kevin Viel, Histonis, Incorporated
AD-184. SAS® Spontaneous Combustion: Securing Software Portability through Self-Extracting Code
Troy Hughes, Datmesis Analytics
AD-196. Using R-Shiny Capabilities in Clinical Programming to create Applications
Prakasam R, Ephicacy Lifescience Analytics
Sujatha Kandukuri, Ephicacy Lifescience Analytics
Tyagrajan Swaminathan, Ephicacy Lifescience Analytics
AD-200. Intro to Coding in SAS Viya
Charu Shankar, SAS Institute
Artificial Intelligence (Machine Learning)
AI-010. Data Mining of Tables: The Barrier for AutomationIlan Carmeli, Beaconcure LTD
AI-106. What's your model really doing? Human bias in Machine Learning
Jim Box, SAS Institute
AI-116. Potential features analysis affect Covid-19 spread
*** BEST PAPER ***
Yida Bao, Auburn University
Philippe Gaillard, FLORIDA STATE UNIVERSITY
AI-130. Generating statistical Tables, Listings, and figures using machine learning, deep learning, and NLP techniques that provide more efficiency to the statistical programming process
Jeyntharkumar A, Symbiance Inc
AI-151. Leveraging AI to process unstructured Clinical data in real-time
Madhusudhan Nagaram, Allogene Therapeutics
Syam Prasad Chandrala, Allogene
Data Standards
DS-002. Subjects Enrolled in Multiple Cohorts within a Study- Challenges and Ideas*** BEST PAPER ***
Peng Du, INNOVENT BIOLOGICS INC
Hongli Wang, INNOVENT BIOLOGICS INC
DS-054. From the Laboratory Toxicity Data Standardization to CTCAE Implementation
Xiaoyin Zhong, Genmab
Jerry Xu, Genamb
DS-061. ADaM Child Data Set: An Alternative Approach for Analysis of Occurrence and Occurrence of Special Interest
Lindsey Xie, Kite Pharma, Inc.
Richann Watson, DataRich Consulting
Jinlin Wang, Kite Pharma, Inc.
Lauren Xiao, Kite Pharma, Inc.
DS-064. Upgrading from Define-XML 2.0 to 2.1
Trevor Mankus, Pinnacle 21
DS-066. Above and Beyond Lesion Analysis Dataset (ADTL)
Raghava Pamulapati, Merck & Co.
DS-095. Making an ADaM Dataset Analysis-Ready
Sandra Minjoe, ICON PLC
DS-112. Standardised MedDRA Queries (SMQs): Beyond the Basics; Weighing Your Options
Richann Watson, DataRich Consulting
Karl Miller, IQVIA
DS-121. How to utilize the EC domain to handle complex exposure data
Varsha Korrapati, Seagen Inc.
Johnny Maruthavanan, Seagen Inc.
DS-134. Redefining Industry Standards: Making CDASH and SDTM Work Together from the Database Level
Chad Fewell, Clinipace
Jesse Beck, Clinipace
DS-139. A Tale of Two CDISC Support Groups - Supporting CDISC Standards is Anything but Standard
Christine McNichol, Labcorp
Mike Lozano, Eli Lilly and Company
DS-197. Clinical Classifications: Getting to know the new kid on the QRS block!
Soumya Rajesh, CSG Llc. - an IQVIA Business
Michael Wise, ApellisPharmaceuticals
Data Visualization and Reporting
DV-040. The power of data visualization: Seaborn vs SGPLOT.(No paper available)
Maryna Aksaniuk, Quartesian
DV-056. Rita: Automated Transformations, Normality Testing, and Reporting
Daniel Mattei, TechData Service Company LLC
DV-071. Introduction to Annual Reporting for Beginners!
Akshita Gurram, Seagen Inc.
Mamatha Mada, Seagen
DV-073. SAS ® ODS Application of Interactive and Informative Clinical Trial Reports
Luwei Pang, MSD
Aiming Yang, Merck & Co.
DV-074. Metadata Driven Approach for Creation of Clinical Trial Figures
Jeremy Gratt, Modular Informatics LLC
Qiuhong Jia, Seagen Inc.
Girish Kankipati, Seagen Inc
DV-082. Building Dashboards for Data Review and Visualization using R Shiny
John saida Shaik, Seagen Inc.
Sreeram Kundoor, Kite Pharma Inc.
DV-088. Generating Forest and Kaplan Meier graphs for Regulatory Submission: Comparison of SAS and R
*** BEST PAPER ***
Girija Javvaji, Covance Inc
Sivasankar Konda, Covance Inc
DV-089. Generating Bar Chat and Mutipanel graphs using SAS vs R for Regulatory Submission
Girija Javvaji, Covance Inc
Alistair D'Souza, Covance Inc
DV-113. A Dynamic Data Visualization Report for Efficacy Endpoints of Early Oncology Study
Hong Zhang, Merck & Co.
Yixin Ren, Merck & Co.
Huei-Ling Chen, Merck & Co.
DV-120. R And SAS in Analysis Data Reviewer’s Guide and Data Visualization
Fan Lin, Gilead Science
DV-172. SAS® PROC GEOCODE and PROC SGMAP: The Perfect Pairing for COVID-19 Analyses
Louise Hadden, Abt Associates Inc.
DV-173. Copy comments: A Dynamic solution to solve the age-old need
Joseph Cooney, OPKO Health Inc.
DV-181. Designing and Implementing Reporting Meeting Federal Government Accessibility Standards with SAS®
(No paper available)
Louise Hadden, Abt Associates Inc.
DV-185. GIS Challenges of Cataloging Catastrophes: Serving up GeoWaffles with a Side of Hash Tables to Conquer Big Data Point-in-Polygon Determination and Supplant SAS® PROC GINSIDE
Troy Hughes, Datmesis Analytics
e-Posters
EP-007. Clean Messy Clinical Data Using PythonAbhinav Srivastva, Exelixis Inc
EP-032. Using SAS ® to Create a Build Combinations Tool to Support Modularity
Stephen Sloan, Accenture
EP-037. Sponsor-defined Controlled Terminologies: A Tiny Key to a Big Door
Shefalica Chand, Seagen Inc.
EP-063. Unravel the mystery around NONMEM data sets for statistical programmers
Sabarinath Sundaram, Seagen Inc.
Lyma Faroz, Seagen Inc.
EP-068. Begin with the End in Mind: eCOA data from collection to analysis
Frank Menius, YPrime
Monali Khanna, YPrime
Vincent Allibone, YPrime
EP-096. Bookmarking CRFs More Efficiently
Noory Kim, SDC
EP-156. Automation of Clinical Data extracts using Cloud Applications
*** BEST PAPER ***
Syam Prasad Chandrala, Allogene
Madhusudhan Nagaram, Allogene Therapeutics
Chaitanya Chowdagam, Ephicacy Lifescience Analytics
Jegan Pillaiyar, Ephicacy Lifescience Analytics
Kunal Chattopadhyay, ZS Associates
EP-176. Automation using SAS Makes it Easy to Monitor Dynamic Data in Clinical Trial
Wenjun He, EMMES
Freelancers Forum
FF-002. When Will Be a Good Time to Become an Independent Consultant?Raymond Lee, Ray Information Systems
FF-003. Better Business Through Better Records
Evelyn Dyson Lee, IRS
FF-007. How to Prepare for a Tax Audit
Evelyn Dyson Lee, IRS
Margaret Hung, MLW Consulting
Hands-On Training
HT-103. ODS Document & Item Stores: A New BeginningBill Coar, Axio, a Cytel Company
HT-186. Team Code Collaboration in RStudio with Git
(No paper available)
Phil Bowsher, RStudio Inc.
Cole Arendt, RStudio PBC
HT-201. What’s black and white and sheds all over? The Python Pandas DataFrame, the Open-Source Data Structure Supplanting the SAS Data Set
Troy Hughes, Datmesis Analytics
HT-202. Learn to Visualize Market Analysis Data Using SAS® PROC GEOCODE, PROC GINSIDE, and Prescriber Characteristics
(No paper available)
Louise Hadden, Abt Associates Inc.
HT-203. Following Your Footsteps: Maintaining Traceability in ADaM Datasets
Nancy Brucken, IQVIA
Karl Miller, IQVIA
HT-204. How to use Git with your SAS projects
Chris Hemedinger, SAS Institute
HT-205. Everything is Better with Friends: Using SAS in Python Applications with SASPy and Open-Source Tooling (Getting Started)
Matthew Slaughter, Kaiser Permanente Center for Health Research
Isaiah Lankham, University of California Office of the President
HT-206. Getting Started Using SAS Proc SGPLOT for Clinical Graphics
(No paper available)
Josh Horstman, Nested Loop Consulting
HT-207. Using Tplyr to Create Clinical Tables
(No paper available)
Mike Stackhouse, Atorus Research
Jessica Higgins, Atorus
Leadership Skills
LS-029. Developing and running an in-house SAS Users GroupStephen Sloan, Accenture
LS-033. Advanced Project Management beyond Microsoft Project, Using PROC CPM, PROC GANTT, and Advanced Graphics
Stephen Sloan, Accenture
Lindsey Puryear, SAS Institute
LS-047. Leading into the Unknown? Yes, we need Change Management Leadership
Kevin Lee, Genpact
LS-058. Visualization of Programming Activities and Deliveries for Multiple Clinical Studies
Zhouming(Victor) Sun, Astrazeneca
LS-098. Schoveing Series 5: Your Guide to a Quality NO
Priscilla Gathoni, AstraZeneca, Statistical Programming
LS-101. How Clear Communication & Expectations Improve the CRO – Sponsor Relationship: the CRO Perspective
Corey Evans, LLX Solutions, LLC
Samantha Kennedy, LLX Solutions, LLC
LS-109. Diversity, Equity, and Inclusion in the Workplace: Challenges and Opportunities
(No paper available)
Eunice Ndungu, Merck & Co.
Rohit Alluri, Merck & Co.
Radha Railkar, Merck & Co.
LS-136. Exciting Opportunities for Fresher
Rajinder Kumar, Novartis Healthcare Private Limited
LS-137. Empower Your Programmers: Get the Most from Your Programming Team
*** BEST PAPER ***
Carol Matthews, Advance Research Associates, Inc.
LS-141. Rethinking Programming Assignments
Scott Burroughs, PAREXEL International
LS-147. Agile innovation – an adaptive approach to transformation in Clinical Research Organizations
Aman Bahl, SYNEOS HEALTH
Hrideep Antony, Syneos Health USA
LS-209. In the world of decentralized trials, do we still need to do double programming?
(No paper available)
Nithiya Ananthakrishnan, Algorics
Praveen Garg, AstraZeneca
Dilip Raghunathan, Insmed
Medical Devices
MD-140. Digital Health Technology in Clinical Trials: Opportunities, Challenges and Biometrics Future Re-imaginedKalyan Chakravarthy Buddavarapu, ASTRAZENECA
Sherry Ye, Astrazeneca
Vijay Vaidya, Astrazeneca
MD-174. Measuring Reproducibility and Repeatability of an AI-based Quantitative Clinical Decision Support Tool Having a Medical Decision Point
Douglas Milikien, Accudata Solutions, Inc.
Quick Tips
QT-005. You Don't Know Where That's Been! Pitfalls of Cutting-and-Pasting Directly into the Programming Work FlowDave Hall, Quality Data Services
QT-008. Programmed Value-Level Metadata for Define XML 2.0
Abhinav Srivastva, Exelixis Inc
QT-016. How Simple Table of Content can make CSR Table, Listings, and Figures Easily Accessible?
Yogesh Pande, Merck & Co.
QT-017. Standardizing Procedures for Generating Dose Proportionality Figures to Improve Programming Efficiency
Jianli Ping, Gilead Sciences Inc
Krishna Sivakumar, Gilead Sciences Inc
QT-021. Using Boolean Functions to Excel at Validation Tracking
Noory Kim, SDC
QT-091. Auto Extraction of the Title Description in Table Report
Xingshu Zhu, Merck & Co.
Li Ma, Merck
Bo Zheng, merck
QT-093. SAS® Studio: Creating, Analyzing, and Reporting Data with Built-in & Custom Tasks
Himanshu Patel, Merck & Co.
Chintan Pandya, Merck & Co.
QT-102. Getting odds ratio at Preferred Term (PT) level for safety analysis in R
Kamlesh Patel, Rang Technologies
Jigar Patel, Rang Technologies
QT-114. Avoid Common Mistakes in Preparing the BIMO Deliverables
Chintan Pandya, Merck & Co.
Himanshu Patel, Merck & Co.
QT-135. Data Masking
Sumit Pratap Pradhan, SYNEOS HEALTH
Navneet Agnihotri, Syneos Heath
Rachel Brown, Syneos Health
QT-143. How to create BARDA Safety report for Periodic review
Mrityunjay Kumar, Ephicacy Lifescience Analytics
Dnyaneshwari Nighot, Ephicacy Lifescience Analytics
Nitish Kumar, Ephicacy Lifecience Analytics
Ganeshchandra Gupta, Ephicacy Consulting Group
QT-144. Smart Batch Run your SAS Programs
Wayne Zhong, Accretion Softworks
QT-169. A Beginner’s Guide to Create Series Plots Using SGPLOT Procedure: From Basic to Amazing
*** BEST PAPER ***
Aakar Shah, Neoleukin Therapeutics
Tracy Sherman, Ephicacy
QT-177. Form(at) or Function? A Celebratory Exploration of Encoding and Symbology
(No paper available)
Louise Hadden, Abt Associates Inc.
QT-195. Excel the Data
Naga Madeti, Statistical Programmer
QT-199. Monitoring SDTM Compliance in Data Transfers from CROs
Sunil Gupta, Experis
Real World Evidence and Big Data
RW-020. Understanding Administrative Healthcare Datasets using SAS programming tools.Jayanth Iyengar, Data Systems Consultants LLC
RW-092. Automation of Variable Name and Label Mapping from Raw Data to Analysis Data Standards
Xingshu Zhu, Merck & Co.
Bo Zheng, Merck
Li Ma, Merck
RW-160. RWD (OMOP) to SDTM (CDISC): A primer for your ETL journey
Ashwini Yermal Shanbhogue, None
RW-179. Generating Real World Evidence On The Likelihood Of Metastatic Cancer In Patients Through Machine Learning In Observational Research: Insights For Prevention
Sherrine Eid, SAS Institute
Samiul Haque, SAS Institute, Inc
Robert Collins, SAS Institute, Inc
RW-192. Introduction to Synthetic Control Arm
*** BEST PAPER ***
Venkat Rajagopal, Ephicacy Consulting Group
Abhinav Jain, Ephicacy Consulting Group
Statistics and Analytics
SA-003. Estimating Differences in Probabilities (Marginal Effects) with Confidence IntervalJun Ke, Independent Statistician
Kelly Chao, LLX Solutions, LLC
Corey Evans, LLX Solutions, LLC
SA-004. A SAS macro wrapper for an efficient Deming regression algorithm via PROC IML: The Wicklin method
Natasha Oza, Roche Molecular Systems, Inc.
Ben Wang, BioMarin Pharmaceutical, Inc.
Jesse Canchola, Roche Diagnostics Solutions
SA-009. The Emerging Use of Automation to Address the Challenge of Cross-Table Consistency Checking of Output Used in the Reporting of Clinical Trial Data
Ilan Carmeli, Beaconcure LTD
Keren Mayorov, Beaconcure LTD
Hugh Donovan, Beaconcure LTD
SA-011. Validation of Statistical Outputs Using Automation
Ilan Carmeli, Beaconcure LTD
Yoran Bar, Beaconcure LTD
SA-015. Derivation of Efficacy Endpoints by iRECIST Criteria: A Practical Approach
Ilya Krivelevich, Eisai Inc.
Lei Gao, Eisai Inc.
Richard Kennan, Eisai Inc.
SA-090. Two Methods to Collapse Two Treatment Groups into One Group
Kenneth Liu, Merck & Co.
Ziqiang Chen, Merck & Co., Inc.
SA-104. How RANK are your deciles? Using PROC RANK and PROC MEANS to create deciles based on observations and numeric values.
Lisa Mendez, Emerge Solutions Group
SA-118. Win Ratio Simulation For Power Calculation Made Easy
Lili Li, Inari Medical
Roger Chang, Inari Medical
Benjamin Fine, Inari Medical
Yu-Chen Su, Inari Medical
SA-123. An Expanded Set of SAS Macros for Calculating Confidence Limits and P-values Under Simon’s Two-Stage Design Accounting for Actual and Planned Sample Sizes
*** BEST PAPER ***
Mikhail Melikov, Cytel
Alex Karanevich, EMB Statistical Solutions
SA-142. Analysis of sample size calculations in clinical trial – errors, pitfalls and conclusions
Igor Goldfarb, Accenture
Ritu Karwal, Accenture
Xiaohua Shu, Accenture
SA-149. Simple and Efficient Bootstrap Validation of Predictive Models Using SAS/STAT® Software
Matthew Slaughter, Kaiser Permanente Center for Health Research
Isaiah Lankham, University of California Office of the President
Strategic Implementation
SI-006. New Digital Trends and Technologies in Clinical Trials and Clinical Data ManagementSrinivasa Rao Mandava, Merck
SI-014. Quality Control With External Code
Bill Coar, Axio, a Cytel Company
SI-024. Applying Agile Methodology to Statistical Programming
Gina Boccuzzi, PROMETRIKA, LLC.
SI-028. Getting a Handle on All of Your SAS® 9.4 Usage
Stephen Sloan, Accenture
SI-042. Lessons learned while switching over to SAS Studio from SAS Desktop.
Steve Black, Precision for Medicine
SI-044. Enterprise-level Transition from SAS to Open-source Programming for the whole department
Kevin Lee, Genpact
SI-055. Implementing and Achieving Organizational R Training Objectives
*** BEST PAPER ***
Jeff Cheng, Merck & Co., Inc.,
Abhilash Chimbirithy, Merck & Co.
Amy Gillespie, Merck & Co., Inc.,
Yilong Zhang, Merck & Co., Inc.,
SI-057. External R Package Qualification Process in Regulated Environment
Jane Liao, Merck & Co.
Fansen Kong, Merck & Co., Inc.
Yilong Zhang, Merck & Co., Inc.
SI-065. PROC FUTURE PROOF 1.2 - Linked Data
Danfeng Fu, MSD
Ellie Norris, Merck
Suhas Sanjee, Merck
Susan Kramlik, Merck & Co.
SI-067. Finding Accord: Developing an eCOA Data Transfer Specification (DTS) All Can Agree On.
Frank Menius, YPrime
Monali Khanna, YPrime
Vincent Allibone, YPrime
SI-097. Ensuring Distributed Data custody on Cloud Platforms
Ben Bocchicchio, SAS Institute
Sandeep Juneja, colleague
SI-099. Cyber Resiliency – Computing Platform Modernization
Susan Kramlik, Merck & Co.
Eunice Ndungu, Merck & Co.
Hemu Shere, Merck & Co.
SI-162. Just Say No to Data Listings!
Mercidita Navarro, Genentech
Nancy Brucken, IQVIA
Aiming Yang, Merck & Co., Inc.
Greg Ball, Merck & Co., Inc.
SI-164. Quality Gates: An Overview from Clinical SAS® Programming Perspective
Nagadip Rao, Eliassen Group
Pavan Jupelli, Eliassen Group
SI-168. Vendor Audit: What it is and What to Expect from it
Parag Shiralkar, Sumptuous Data Sciences, LLC
Nagadip Rao, Eliassen Group
SI-187. Creating an Internal Repository of Validated R Packages
(No paper available)
Phil Bowsher, RStudio Inc.
Cole Arendt, RStudio
SI-191. Orchestrating Clinical Sequels with a Strategic Wand - Challenges of introducing Rolling CSRs in a Master Protocol
Neharika Sharma, GlaxoSmithKline Pharmaceuticals
Submission Standards
SS-023. Lessons Learned from Using P21 to Create ADaM define.xml with ExamplesYizhuo Zhong, Merck & Co.
Christine Teng, Merck & Co.
Majdoub Haloui, Merck & Co.
SS-034. Damn*t, The Define!
Julie Ann Hood, Pinnacle 21
Sarah Angelo, Pinnacle 21
SS-035. FDA Advisory Committee Meetings– A Statistical Programmer’s Survival Guide
*** BEST PAPER ***
Phil Hall, Edwards Lifesciences
SS-039. Real Time Oncology Review Readiness from Programming Perspective
Binal Mehta, Merck & Co INC
Patel Mukesh, Merck & Co INC
SS-079. eCOA and SDTM: Bring Order to the Wild West
Vincent Allibone, Yprime
Frank Menius, YPrime
Monali Khanna, YPrime
SS-087. Including Population Information in ADaM define.xml for Better Understanding of Datasets
Hong Qi, Merck & Co.
Majdoub Haloui, Merck & Co.
Guowei Wu, Merck & Co., Inc.
SS-110. A SAS Macro to Support the Supplemental Qualifier Section in cSDRG
Jamuna Purma, Merck & Co.
Bindya Bindya Vaswani, Merck
SS-152. Explanations in the Study Data Reviewer’s Guide: How’s It Going?
Kristin Kelly, Pinnacle 21
SS-154. A Standardized Reviewer’s Guide for Clinical Integrated Analysis Data
Srinivas Kovvuri, ADC Therapeutics USA
Kiran Kundarapu, Merck & Co., Inc
Satheesh Avvaru, Alexion AstraZeneca Rare Disease
Randi McFarland, Independent Consultant
SS-158. A Practical Approach to Preparing Documentation for Clinical Registries
Jennifer McGrogan, Reata Pharmaceuticals
Rex Tungala, Reata Pharmaceuticals
Mario Widel, Reata Pharmaceuticals Inc.