THE COMMUNITY ARCHIVE

PharmaSUG 2020 Papers Archive

Browse indexed publications from PharmaSUG in 2020. Material labels distinguish papers, presentations, posters and proceedings listings where the source provides them.

138 papers · Showing 1–40

PharmaSUG · 2020Paper AD-052PharmaSUG 2020

‘This Is Not the Date We Need. Let’s Backdate’: An Approach to Derive First Disease Progression Date in Solid Tumor Trials

Girish Kankipati; Boxun Zhang

Source category: Applications Development

Author collections: Girish Kankipati · Boxun Zhang

PharmaSUG · 2020Paper AP-005PharmaSUG 2020

%MVMODELS: a Macro for Survival and Logistic Analysis

Jeffrey Meyers

Source category: Advanced Programming

Author collections: Jeffrey Meyers

PharmaSUG · 2020Paper EP-176PharmaSUG 2020

10 things you need to know about PMDA eSubmission

Yuichi Nakajima

Source category: ePosters

Author collections: Yuichi Nakajima

PharmaSUG · 2020Paper SA-207PharmaSUG 2020

A Brief Introduction to Performing Statistical Analysis in SAS, R & Python

Erica Goodrich; Daniel Sturgeon

Source category: Statistics and Analytics

Author collections: Erica Goodrich · Daniel Sturgeon

PharmaSUG · 2020Paper QT-183PharmaSUG 2020

A Brief Understanding of DOSUBL beyond CALL EXECUTE

Ajay Sinha; M Chanukya Samrat

Source category: Quick Tips

PharmaSUG · 2020Paper SA-034PharmaSUG 2020

A Doctor’s Dilemma: How Propensity Scores Can Help Control For Selection Bias in Medical Education

Deanna Schreiber-Gregory

Source category: Statistics and Analytics

Author collections: Deanna Schreiber-Gregory

PharmaSUG · 2020Paper EP-064PharmaSUG 2020

A Guide for the Guides: Implementing SDTM and ADaM standards for parallel and crossover studies

Azia Tariq; Janaki Chintapalli

Source category: ePosters

PharmaSUG · 2020Paper AD-130PharmaSUG 2020

A Novel Solution for Converting Case Report Form Data to SDTM using Configurable Transformations

Sara Shoemaker; Matthew Martin; Robert Kleemann; David Costanzo; Tobin Stelling

Source category: Applications Development

Author collections: Sara Shoemaker · Robert Kleemann

PharmaSUG · 2020Paper QT-035PharmaSUG 2020

A SAS Macro for Calculating Confidence Limits and P-values Under Simon’s Two-Stage Design

Alex Karanevich; Michael Ames

Source category: Quick Tips

Author collections: Alex Karanevich

PharmaSUG · 2020Paper QT-213PharmaSUG 2020

A SAS Macro for Dynamic Assignment of Page Numbers

Manohar Modem; Bhavana Bommisetty

Source category: Quick Tips

Author collections: Manohar Modem · Bhavana Bommisetty

PharmaSUG · 2020Paper QT-315PharmaSUG 2020

A SAS macro for tracking the Status of Table, Figure and Listing (TFL) Programming

Yuping Wu; Sayeed Nadim

Source category: Quick Tips

Author collections: Yuping Wu

PharmaSUG · 2020Paper AD-055PharmaSUG 2020

A Set of VBA Macros to Compare RTF Files in a Batch

Jeff Xia; Shunbing Zhao

Source category: Applications Development

Author collections: Jeff Xia · Shunbing Zhao

PharmaSUG · 2020Paper SD-281PharmaSUG 2020

A Single, Centralized, Biometrics Team Focused Collaboration System for Analysis Projects

Chris Hardwick; Justin Slattery; Hans Gutknecht

Source category: Software Demonstrations (Tutorials)

PharmaSUG · 2020Paper QT-128PharmaSUG 2020

A Solution to Look-Ahead Observations

Yongjiang (Jerry) Xu; Yanhua (Katie) Yu

Source category: Quick Tips

Author collections: Yongjiang (Jerry) Xu

PharmaSUG · 2020Paper AD-347PharmaSUG 2020

A Tool to Organize SAS Programs, Output and More for a Clinical Study

Yang Gao

Source category: Applications Development

Author collections: Yang Gao

PharmaSUG · 2020Paper LS-059PharmaSUG 2020

An Effective Management Approach for a First-Time Study Lead

Himanshu Patel; Jeff Xia

Source category: Leadership Skills

Author collections: Himanshu Patel · Jeff Xia

PharmaSUG · 2020Paper DV-166PharmaSUG 2020

An Introduction to the ODS Destination for Word

David Kelley

Source category: Data Visualization and Reporting

PharmaSUG · 2020Paper MD-360PharmaSUG 2020

An Overview of Medical Device Data Standards

Shilpakala Vasudevan

Source category: Medical Devices

Author collections: Shilpakala Vasudevan

PharmaSUG · 2020Paper SS-156PharmaSUG 2020

Analysis Package e-Submission – Planning and Execution

Abhilash Chimbirithy; Saigovind Chenna; Majdoub Haloui

Source category: Submission Standards

Author collections: Abhilash Chimbirithy · Saigovind Chenna · Majdoub Haloui

PharmaSUG · 2020Paper LS-008PharmaSUG 2020

Are you Ready? Preparing and Planning to Make the Most of your Conference Experience

Richann Watson; Louise Hadden

Source category: Leadership Skills

Author collections: Richann Watson · Louise Hadden

PharmaSUG · 2020Paper SI-206PharmaSUG 2020

Assessing Performance of Risk-based Testing

Amber Randall; Bill Coar

Source category: Strategic Implementation

Author collections: Amber Randall · Bill Coar

PharmaSUG · 2020Paper SA-072PharmaSUG 2020

Assigning agents to districts under multiple constraints using PROC CLP

Stephen Sloan; Kevin Gillette

Source category: Statistics and Analytics

Author collections: Stephen Sloan · Kevin Gillette

PharmaSUG · 2020Paper AI-242PharmaSUG 2020

Automate your Safety tables using Artificial Intelligence & Machine Learning

Roshan Stanly; Ajith Baby Sadasivan; Limna Salim

Source category: Artificial Intelligence (Machine Learning)

Author collections: Roshan Stanly · Ajith Baby Sadasivan · Limna Salim

PharmaSUG · 2020Paper SS-159PharmaSUG 2020

Automating CRF Annotations using Python

Hema Muthukumar; Kobie O’Brian; Julie Stofel

Source category: Submission Standards

Author collections: Kobie O’Brian · Julie Stofel

PharmaSUG · 2020Paper DV-157PharmaSUG 2020

Automating of Two Key Components in Analysis Data Reviewer’s Guide

Shunbing Zhao; Jeff Xia

Source category: Data Visualization and Reporting

Author collections: Shunbing Zhao · Jeff Xia

PharmaSUG · 2020Paper QT-209PharmaSUG 2020

Automation of Conversion of SAS Programs to Text files

Sachin Aggarwal; Sapan Shah

Source category: Quick Tips

Author collections: Sachin Aggarwal · Sapan Shah

PharmaSUG · 2020Paper DV-132PharmaSUG 2020

Automation of Flowchart using SAS

Xingshu Zhu; Bo Zheng

Source category: Data Visualization and Reporting

Author collections: Xingshu Zhu · Bo Zheng

PharmaSUG · 2020Paper DS-248PharmaSUG 2020

Best practices for annotated CRFs

Amy Garrett

Source category: Data Standards

Author collections: Amy Garrett

PharmaSUG · 2020Paper RW-113PharmaSUG 2020

Better to Be Mocked Than Half-Cocked: Data Mocking Methods to Support Functional and Performance Testing of SAS® Software

Troy Hughes

Source category: Real World Evidence and Big Data

Author collections: Troy Hughes

PharmaSUG · 2020Paper LS-265PharmaSUG 2020

Building a Strong Remote Working Culture – Statistical Programmers Viewpoint

Ravi Kankipati; Prasanna Sondur

Source category: Leadership Skills

Author collections: Ravi Kankipati

PharmaSUG · 2020Paper DV-148PharmaSUG 2020

Butterfly Plot for Comparing Two Treatment Responses

Raghava Pamulapati

Source category: Data Visualization and Reporting

Author collections: Raghava Pamulapati

PharmaSUG · 2020Paper SA-051PharmaSUG 2020

Calculation of Cochran–Mantel–Haenszel Statistics for Objective Response and Clinical Benefit Rates and the Effects of Stratification Factors

Girish Kankipati; Chia-Ling Ally Wu

Source category: Statistics and Analytics

Author collections: Girish Kankipati · Chia-Ling Ally Wu

PharmaSUG · 2020Paper MD-020PharmaSUG 2020

CDISC Standards for Medical Devices: Historical Perspective and Current Status

Carey Smoak

Source category: Medical Devices

Author collections: Carey Smoak

PharmaSUG · 2020Paper DS-117PharmaSUG 2020

CDISC-compliant Implementation of iRECIST and LYRIC for Immunomodulatory Therapy Trials

Kuldeep Sen; Sumida Urval; Yang Wang

Source category: Data Standards

Author collections: Kuldeep Sen · Yang Wang

PharmaSUG · 2020Paper SS-150PharmaSUG 2020

Challenges and solutions for e-data submission to PMDA even after submission to FDA

Akari Kamitani; HyeonJeong An; Yura Suzuki; Malla Reddy Boda; Yoshitake Kitanishi

Source category: Submission Standards

Author collections: Akari Kamitani · Yura Suzuki · Malla Reddy Boda · Yoshitake Kitanishi

PharmaSUG · 2020Paper AD-114PharmaSUG 2020

Chasing Master Data Interoperability: Facilitating Master Data Management Objectives Through CSV Control Tables that Contain Data Rules that Support SAS® and Python Data-Driven Software Design

Troy Hughes

Source category: Applications Development

Author collections: Troy Hughes

PharmaSUG · 2020Paper AD-171PharmaSUG 2020

Clinical Database Metadata Quality Control: Two Approaches using SAS and Python

Craig Chin; Lawrence Madziwa

Source category: Applications Development

PharmaSUG · 2020Paper EP-099PharmaSUG 2020

Color Data Listings and Color Patient Profiles

Charley Wu

Source category: ePosters

Author collections: Charley Wu

PharmaSUG · 2020Paper DS-365PharmaSUG 2020

Creating SDTMs and ADaMs CodeList Lookup Tables

Sunil Gupta

Source category: Data Standards

Author collections: Sunil Gupta

PharmaSUG · 2020Paper AD-142PharmaSUG 2020

Data Library Comparison Macro %COMPARE_ALL

Jeffrey Meyers

Source category: Applications Development

Author collections: Jeffrey Meyers