Austin, Texas
May 22-25, 2022

Advanced Programming

AP-019. From %let To %local; Methods, Use, And Scope Of Macro Variables In Sas Programming
Jayanth 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 Implementation
Chengxin 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
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 Automation
Ilan 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

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 ***

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


EP-007. Clean Messy Clinical Data Using Python
Abhinav 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 Beginning
Bill 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 Group
Stephen 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
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-imagined
Kalyan 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 Flow
Dave 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 Interval
Jun 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 Management
Srinivasa 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 Examples
Yizhuo 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.