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secondary endpoint

25 papers and 5 presentations; 30 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG 2026 An Agentic AI Framework That Reads Statistical Analysis Plans and Generates TFL Table of Contents Siqi Wang,
Toshio Kimura,
Songgu Xie,
Weiming Du
source 6
PharmaSUG 2026 Oncology Solid Tumor Subcutaneous vs Intravenous Late-stage Study Analysis Sumanjali Mangalarapu,
Chuqing Chen,
Anilkumar Anksapur
source 11
PHUSE US 2026 AI Reading and Understanding the SAP to Generate the TFL TOC Siqi Wang,
Toshio Kimura
source
presentation source
6
PHUSE US 2026 Prompt Engineering in Gen AI: A Game Changer for the professional development of Statistical Programmers and Data Scientists Kevin Lee source
presentation source
8
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 Development of Statistical Scientists for Pharmaceutical Drug Development at India Global Capability Centres Suresh Chenji source
presentation source
6
PharmaSUG 2025 A Novel ADEFF Design with Varying Baseline Type Selections Tingting Tian,
Chao Su,
Fan Wang,
Pengfei Zhu
source 6
PharmaSUG 2025 AI is coming for you: New Biometric Leadership in the era of Gen AI Kevin Lee source 7
PharmaSUG 2025 Generative AI in Biometrics: Transforming Clinical Trials with Supercharged Efficiency an Innovation Kevin Lee source 6
PharmaSUG 2025 Guidance from the FDA authored "Submitting Patient-Reported Outcome Data in Cancer Clinical Trials" and recommendations for their implementation in study CDISC COA data. Charity Quick source 14
PHUSE US 2025 Efficient TFL Review within Statistical Programming - Using R and SAS Siddharth Kumar source
presentation source
8
PHUSE US 2025 eProtocol and the Promise of Automation Bill Qubeck,
Suhas Giriraj
source
presentation source
17
PHUSE US 2025 Revolutionising Clinical Trials: Gen AI-Powered Biometrics Breakthroughs Kevin Lee source
presentation source
6
PHUSE EU 2024 Quality Tolerance Limits: Understanding the added value and statistical need of implementing QTLs to assure subject safety and data quality Nathalie van Borrendam source
presentation source
3
PHUSE EU 2024 Strategies to Improve Understanding of Estimands and Analysis Section of Statistical Analysis Plan Inderjeet Arora source
presentation source
8
PHUSE EU 2022 Performance Traps in Multiple Imputation Analysis Using Mixed Model Repeated Measures [presentation] Piotr Karasiewicz source
video
17
PharmaSUG 2022 FDA Advisory Committee Meetings - A Statistical Programmer's Survival Guide Phil Hall source 8
PHUSE US 2022 The Complexity and Magnitude of Participant Reactogenicity Data [presentation] Gunasekaran Subramaniam,
Katrien Van der Donck
source
video
21
PHUSE US 2021 Standing Room Only Presentation: DV10: Topline Results Dashboards with Rmarkdown & Flexdashboard [presentation] Harsha Kalikivayi,
Robert Adams
source 26
PharmaSUG 2021 GCIG Criteria, Programming Makes It Easy Liming Xie,
Wei Wei
source 9
PHUSE EU 2020 Using R Shiny to Increase the Efficiency of a Study Team [presentation] Emma Moore source
video
12
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 Dashboarding Analytics for Oncology Endpoint Data Using SAS Vidya Muthukumar source
presentation source
7
PHUSE US 2019 Striking a Balance: Adoption of Analysis Results Metadata (ARM) in Early Development Studies Janet Low,
Pranab K. Mitra
source
presentation source
6
PharmaSUG 2016 Programming checks: Reviewing the overall quality of the deliverables without parallel programming Shailendra Phadke,
Veronika Csom
source 8
PharmaSUG CN 2015 Summary level clinical site data for data integrity review and inspection planning in NDA and BLA submission [presentation] Jingwei Gao,
Nancy Bauer
41
PHUSE EU 2012 To EC or Not EC...that is the Question! Hiren Naygandhi source
presentation source
8
PharmaSUG 2010 The Compliance and Implementation of Clinical Trial Outcome Disclosure on ClinicalTrials.gov Eric T. Sun,
Craig Anderson
13
PHUSE EU 2009 ClinicalTrials.gov - a programmers perspective Ralf Minkenberg source
presentation source
6
SUGI 1992 The Use of SAS/GRAPH Software in the Management of Clinical Trials MaryAnne DePesquo Hope source 6

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