| PharmaSUG |
2026 |
A Practical Approach to Multiple-Period CLINSITE Preparation |
Liyuan Huang, Amanda Plaisted, Sreedhar Bodepudi |
source |
6 |
| PharmaSUG |
2026 |
Algorithms to align the distribution of follow-up across independently collected cohorts when comparing time to event endpoints using conventional Kaplan Meier and Cox regression methods. |
Shankar Srinivasan, Yvonne Buttkewitz, Regina Uttenreuther, Baldeep Chani Talwar, Manjari Dissanayake |
source |
12 |
| PharmaSUG |
2026 |
Oncology Solid Tumor Subcutaneous vs Intravenous Late-stage Study Analysis |
Sumanjali Mangalarapu, Chuqing Chen, Anilkumar Anksapur |
source |
11 |
| PharmaSUG |
2026 |
Trusting Your R Packages: A Practical, Risk-Based Approach to External Package Validation |
Radhika Etikala, Valeria Duran |
source |
14 |
| PHUSE US |
2026 |
Advancing Precision Medicine and Regulatory Readiness: Data Harmonisation and Statistical Methods for Companion Diagnostics Bridging Studies |
Ummul Vara Qurratul Ain |
source presentation source |
10 |
| PHUSE US |
2026 |
Complex Trials, Simple Disclosures: Streamlined Transparency of Innovative Study Designs [presentation] |
Ritama Gupta Dempsey |
source |
15 |
| PHUSE US |
2026 |
Mapping Minimal Residual Disease (MRD) Biomarker Data in Hematologic Malignancies: Clinical Significance and Data Standards in SDTM and ADaM |
Jyothi Nelakurthi |
source presentation source |
8 |
| PHUSE US |
2026 |
Prompting for Precision: Leveraging Agentic Workflows to Accelerate Clinical Trial Document Understanding |
Jaya Simha Inampudi |
source presentation source |
14 |
| PHUSE APAC |
2026 |
Crafting a recipe for success : Aligning Target Product Profiles and study design to ensure statistical significance translates to clinical relevance and role of DGF |
Soumitra Kar, Novo Nordisk GBS |
source presentation source |
9 |
| PHUSE APAC |
2026 |
The AI-Powered Scribe: An Agentic Framework for Automated CSR Authoring |
Allwyn Dsouza |
source presentation source |
7 |
| PHUSE EU |
2025 |
Interactive Insights: Leveraging R Shiny for Enhanced Data Visualisation in Clinical Trial Readouts [presentation] |
Carolyn Fisher, Elisabeth Deutschmann |
source |
20 |
| PHUSE EU |
2025 |
Statistical Endpoints and Analysis in Diagnostic Imaging: The Matrix Has You and Your Data |
Srinivas Lanka, James Sykes |
source presentation source |
17 |
| PharmaSUG |
2025 |
A Novel ADEFF Design with Varying Baseline Type Selections |
Tingting Tian, Chao Su, Fan Wang, Pengfei Zhu |
source |
6 |
| PHUSE EU |
2024 |
Failed Clinical Trials: How to Benefit From Negative Experience |
Anna Amosova |
source presentation source |
13 |
| PHUSE EU |
2024 |
Strategies to Improve Understanding of Estimands and Analysis Section of Statistical Analysis Plan |
Inderjeet Arora |
source presentation source |
8 |
| PHUSE EU |
2024 |
Transcriptomics - A Demanding Data Analysis that Expands the Limits of Regulated Clinical Data Handling |
Lea Yoshida Hildebrandt |
source presentation source |
6 |
| WUSS |
2024 |
An introduction to Quarto: A Versatile Open-Source Tool for Data Reporting and Visualization |
Joshua J. Cook, Swann Arp Adams |
source |
18 |
| PharmaSUG CN |
2024 |
Best Overall Response (BOR) Confirmation in Oncology Clinical Trials: Insights from RECIST 1.1 |
Jihai Li |
source |
15 |
| PharmaSUG CN |
2024 |
Implementing the treatment policy estimation for continuous variable with multiple imputation |
Andy Sun |
source |
17 |
| PharmaSUG |
2024 |
An introduction to Quarto: A Versatile Open-Source Tool for Data Reporting and Visualization |
Joshua J. Cook |
source |
18 |
| PharmaSUG |
2024 |
Implementation of composite estimands for responder analysis based on change from baseline in non-solid tumours |
Reshma Radhakrishnan |
source |
11 |
| PharmaSUG |
2024 |
Quarto 1.4: Revolutionizing Open-source Dashboarding Capabilities |
Joshua J. Cook, Kirk Paul Lafler |
source |
17 |
| PHUSE US |
2024 |
EOSS_MMRM V1.0: A Shiny Application for Estimand-Oriented Sample Size and Power Simulation Using MMRM Modelling |
Xiaoli Kong, Jing Dai |
source presentation source |
8 |
| PHUSE US |
2024 |
Ups, Downs, and FDA Crowns - Lessons Learned from BIMO Submission Adventures! [presentation] |
Sushant Thakare |
source |
21 |
| PHUSE EU |
2023 |
Efficacy Endpoints in Adjuvant and Neo-Adjuvant Oncology Trials |
Yuliia (Piddubna) Cherednichenko, Anna Amosova |
source presentation source |
15 |
| PHUSE EU |
2023 |
Interaction with the FDA During and After a Type C Meeting, From the Perspective of a Statistical Programmer |
Dieter Hartz |
source presentation source |
5 |
| PHUSE EU |
2023 |
Optimizing Clinical Trial Design with Real-Time Sample Size Calculation and Enrollment Projection: A Shiny Dashboard Solution |
Dony Sabu |
source presentation source |
5 |
| PharmaSUG |
2023 |
Leverage and Enhance CDISC TAUGs to Build More Traceability for and Streamline Development of Efficacy ADaM in Oncology Studies |
Xiangchen (Bob) Cui |
source |
29 |
| PharmaSUG |
2023 |
What-s the story in your subgroup analysis |
Lucy Dai |
source |
6 |
| PHUSE EU |
2021 |
Does No Errors Equal High Quality? [presentation] |
Julie Solbjerg Appel, Sanna Herrgård |
source video |
23 |
| PHUSE EU |
2021 |
How Has the Immunotherapy Era Changed Response Criteria? [presentation] |
Anna Amosova |
source video |
30 |
| PHUSE US |
2021 |
Standing Room Only Presentation: DS06: CDISC Analysis Results Standard [presentation] |
Bess LeRoy |
source |
25 |
| PharmaSUG |
2021 |
BIMO SAS Macros and Programming Tools |
Mi Young Kwon, Rohit Kamath |
source |
12 |
| PHUSE EU |
2020 |
Define-XML for ADaM: Clinical Standards Toolkit vs. Pinnacle 21? [presentation] |
Frederikke Høyer |
source video |
16 |
| PHUSE EU |
2020 |
Let CDISC Be |
Roxane Debrus, Silvia Faini |
source video presentation source |
8 |
| PHUSE EU |
2020 |
MI FOR MI, OR HOW TO HANDLE MISSING INFORMATION WITH MULTIPLE IMPUTATION |
Daria Shamaida |
source video presentation source |
8 |
| PHUSE EU |
2020 |
Power BI in Clinical Data Exploration: Powerful Visuals that Answer Relevant Questions |
Roxane Debrus |
source video presentation source |
11 |
| PHUSE EU |
2020 |
The TransCelerate Hackathon: Accelerating Development [presentation] |
Johannes Ulander |
source video |
26 |
| PHUSE EU |
2020 |
Using R Shiny to Increase the Efficiency of a Study Team [presentation] |
Emma Moore |
source video |
12 |
| PharmaSUG |
2020 |
Automating of Two Key Components in Analysis Data Reviewer's Guide |
Shunbing Zhao, Jeff Xia |
source |
8 |
| PHUSE US |
2020 |
Data Science Project (Educating for the Future Working Group) |
Aldir Medeiros Filho, Sascha Ahrweiler |
source presentation source |
10 |
| PHUSE US |
2020 |
Design and Conduct of Clinical Trials: Past Present and Future. New Innovative Technology Methods |
George Obsekov |
source presentation source |
12 |
| PHUSE US |
2019 |
Misuse and Misapplication in Statistical Data Analysis - A Topic that Never Goes Out of Style |
Corinna Miede |
source presentation source |
12 |
| PHUSE EU |
2018 |
How to Write ADaM Specifications Like a Ninja |
Caroline Francis |
source poster source |
5 |
| PHUSE US |
2018 |
Drug-Induced Liver Injury (DILI) Classification Using FDA-Approved Drug Labeling and FAERS Data - FDA |
Qais Hatim |
source presentation source |
31 |
| PHUSE US |
2018 |
Modeling and Text Analysis to Empower FAERS Adverse Event Mitigation |
Qais Hatim, Emily McRae |
source presentation source |
24 |
| PharmaSUG |
2018 |
Programmer's Guide for OSI Deliverables - Creation of Site Level Summary Dataset and Automation of BIMO Listins Generation |
Charanjit Kahlon, Kristie Kooken, Bhavin Busa, Dharmendra Tirumalasetti |
source |
10 |
| PharmaSUG |
2018 |
Sense and Censorability: Learn censoring techniques with ADTTE for your survival |
Shilpakala Vasudevan |
source |
12 |
| SGF |
2018 |
Auto-populating Microsoft PowerPoint Presentations So You Don't Have To |
Kaitie Lawson |
source |
17 |
| PHUSE EU |
2017 |
Futile or Not? An Interim Analysis Case Study |
Ingrid Franklin |
source presentation source |
9 |
| PHUSE EU |
2017 |
Power Calculation in a Multi-Stage Design, Following the Main Endpoint, A Binomial DIstribution |
Antonio Nieto, Javier Gómez |
source presentation source |
4 |
| PharmaSUG |
2017 |
Automated DSMB Presentation in SAS: Yeah, I'd Submit That! How to auto populate PowerPoint presentations so you don't have to |
Brett Jepson, Kaitie Lawson |
source |
17 |
| PharmaSUG |
2017 |
ClinicalTrials.gov Results: an End of Study Deliverable That Should Be Considered at Study Startup |
Maya Barton, Elizabeth Paynter |
source |
9 |
| PharmaSUG |
2016 |
Working with Composite Endpoints: Constructing Analysis Data |
Pushpa Saranadasa |
source |
7 |
| PHUSE EU |
2014 |
Multiple Imputation: Better than Single Imputation in Pain Studies |
Ashik Chowdhury |
source presentation source |
12 |
| PHUSE EU |
2014 |
Submitting Summary Level Site Data: Overview, Implementation and Case Studies |
Robert F. Woolson, Jeffrey M. Abolafia, Ben Vaughn |
source presentation source |
9 |
| PharmaSUG CN |
2014 |
Design and Construct Efficacy Analysis Datasets in Later Phase Oncology Study |
Huadan Li, Changhong Shi |
|
9 |
| PharmaSUG |
2014 |
Methodology for Non-Randomized Clinical Trials: Propensity Score Analysis |
Dan Conroy |
source |
5 |
| PharmaSUG |
2014 |
Risk-Based Approach to Identifying and Selecting Clinical Sites for Sponsor's Preparation for FDA/EMA Inspection |
Xiangchen (Bob) Cui |
source |
21 |
| PHUSE EU |
2013 |
Efficacy Endpoints in Oncology |
Angelo Tinazzi |
source |
9 |
| PHUSE EU |
2013 |
Oncology Endpoints: An Unexpected Journey |
Waseem Jugon, Mijanur Rahman |
source |
12 |
| PharmaSUG |
2013 |
Experiences in Preparing Summary Level Clinical Site Data within NDA's Submission for FDA's Inspection Planning |
Xiangchen (Bob) Cui |
source |
19 |
| PHUSE EU |
2012 |
East6: Software for Designing, Simulating and Monitoring Group Sequential Trials |
Hrishikesh Kulkarni, Sheetal Solanki |
source presentation source |
12 |
| SGF |
2012 |
Use of Cutoff and SAS Code Nodes in SAS Enterprise Miner to Determine Appropriate Probability Cutoff Point for Decision Making with Binary Target Models |
Yogen Shah |
source |
6 |
| MWSUG |
2011 |
Objective tumor response and RECIST criteria in cancer clinical trials |
Jian Yu |
|
6 |
| SGF |
2011 |
Randomizing Small Strata Groups: Balancing Baseline Population Measures While Staying True to a Chosen Allocation Strategy, an Alternative to PROC SURVEYSELECT |
Gregg M. Oginz |
source |
12 |
| SGF |
2009 |
Fitting Cox Model Using PROC PHREG and Beyond in SAS |
Lea Liu, Sandy A. Forman, Bruce A. Barton |
source |
10 |
| PharmaSUG |
2006 |
Sample Size Calculation and Timeline Estimate for Progression-Free Survival |
Chung-Kuei Chang |
|
10 |
| PharmaSUG |
2005 |
Power Analysis and Sample Size Estimation using Bootstrap |
Xiaomei Peng, Guangbin Peng, Celedon Gonzales |
|
7 |
| PharmaSUG |
2005 |
Some Statistical Programming Considerations for e-Submission |
Hang Pang |
|
6 |
| PharmaSUG |
2004 |
PROC POWER: V9.1 |
Deborah J. Bauer |
|
6 |
| SUGI |
2004 |
PROC POWER in SAS 9.1 |
Deborah J. Bauer, Russell M. Lavery |
source |
7 |
| NESUG |
2001 |
Power and Sample Size Determination for Linear Models |
John M. Castelloe |
|
13 |
| SESUG |
2001 |
Power and Sample Size Determination for Linear Models |
John M. Castelloe |
source |
13 |
| SCSUG |
2001 |
Power and Sample Size Determination for Linear Models |
John M. Castelloe, Ralph G. O'Brien |
|
13 |
| PharmaSUG |
2001 |
Power and Sample Size Determination for Linear Models |
John M. Castelloe |
|
14 |
| PharmaSUG |
2001 |
Using SAS Version 8.1 Output Delivery System to Automate Two Sample |
Test Selection |
|
4 |
| SUGI |
2001 |
Power and Sample Size Determination for Linear Models |
John M. Castelloe, Ralph G. O'Brien |
source |
13 |
| PharmaSUG |
2000 |
Using SAS for the Statistical Analysis of a Bivariate Primary Endpoint in a Clinical Trial of Chronic Fatigue Syndrome (CFS) |
Naum M. Khutoryansky, David R. Strayer, William A. Carter |
|
3 |