Introduction

Katja is a consultant with over 20 years of experience in the pharmaceutical and life sciences industry, specializing in SAS, web technologies, ADaM, Define.xml, and TLF generation, and a strong advocate for open-source collaboration. She spent more than two decades at Bayer and now serves as community manager for the OpenStudyBuilder open-source project on behalf of Novo Nordisk. Katja also runs glacon.eu/portal, a platform promoting open-source solutions for pharma, and is a board member of the CDISC Open Source Alliance.

Publications & Presentations

Open-Source Practicalities and the Legal Side, PHUSE EU Connect 2025 (paper, presentation)
The Life of a Statistical Analyst: Evolving Through Time and Technology, PHUSE SDE Frankfurt 2025 (presentation)
Navigating Open Seas: Exploring Open-Source Technology in Clinical Data Analysis, PHUSE SDE Copenhagen 2024 (presentation)
Revolutionising Clinical Trials: The Impact of OpenStudyBuilder on Automation and Insights, PHUSE SDE Frankfurt 2024 (presentation)
OpenStudyBuilder - Experimentation Examples - PHUSE SDE Heidelberg 2023 (presentation)
OpenStudyBuilder - The Game Changer - PHUSE EMEA Summer SDE 2022 (presentation)
CDISC Open Source Alliance (COSA) - An Introduction - CDISC EU Interchange 2022 (presentation)
Proprietary vs. Open-Source - What's More FAIR? - PHUSE EMEA Winter SDE 2021 (presentation)
Open Source in Pharma - What's Going On? - PHUSE EMEA Winter SDE 2021 (presentation)
Open Source SAS Macros - What? Where? How? - SAS Global Forum 2021 (recording & paper)
Continuous Integration for SAS Macros - PhUSE EMEA Spring SDE 2021 (presentation)
FAIR for Source Code - PhUSE SDE Basel Aug 2020 (presentation, recording)
Clinical Data Science - Going the Open Source Route - PhUSE BitSize Webinar 2020 (presentation, recording)
Creating and Maintaining Open Source: Why and How? - CDISC Virtual Interchange 2020 (presentation)
Open Source SAS Makros - Was gibt es? Wie nutze ich es? Was sollte ich beachten? - KSFE 2020, Mannheim (paper, presentation)
Open Source for Pharma - Solutions, Challenges and Visions, PhUSE SDE 2019, Copenhagen (presentation)
Open Source Selection, PhUSE SDE Heidelberg 2019 (poster)
Programminhalte extrahieren und modifizieren mit SAS (German), KSFE 2019, Berlin (paper, presentation)
Additional Publications done as employee can be found at linkedIn

Videos

OpenStudyBuilder Introduction & Demonstration - 2025 (YouTube, 11 min)
Open Source Licenses - Practicalities and the Legal Side - 2024 (YouTube, 27 min)
OpenStudyBuilder - Demonstration of Application - 2023 (YouTube, 28 min)
FAIR for Source Code - Digging the Gold of Programming - PhUSE Recording (YouTube, 28 min)
Clinical Data Science - Going the Open Source Route - PhUSE Recording (YouTube, 30 min)
Open Source Portal for Clinical Study Evaluations - A Quick Glance (YouTube, 4 min)
Open Source for Pharma - Solutions, Challenges and Visions (YouTube, 17 min)
Using an Open Source SAS Macro - How to do? (YouTube, 33 min)
Open Source Collaborations in Clinical Study Evaluations (YouTube, 7 min)

Programming

SAS MACRO

SAS

Web Development (JavaScript, React)

JAVA

R / Python

Visual Basic

Tools

OpenStudyBuilder (Community Manager)

Open Source Portal

Kimai Plugin - ApprovalBundle

TimeKex: Timetrack - Kimai meets Excel

Reindeer - Render SAS Results

SMILE - Smart SAS Macros

Development

General

2005 Dual education study of Computer Science - Diplom Ingenieur Informatik (BA)
2005 Schering AG - Statistical Standard Coordinator in Global Biostatistics
2014 Bayer AG - Clinical Data Process Technology Specialist
2019 Katja Glass Consulting - becoming independent (part time)
2020 Bayer AG - Expert Statistical Analyst (part time)
2021 CDISC COSA Board Member
2022 OpenStudyBuilder Community Manager

PhUSE

Stream chair/co-chair from 2020
EU Connect Chair 2018
PhUSE conference co-chair 2017
Chair/co-chair of the PhUSE SDE Germany 2012, 2013, 2014, 2015
Co-chair of Coding Solution stream 2014, 2015, 2016
PhUSE App developer 2013-2017

Projects as Employee

Implementation, Documentation, Validation, Training mainly for SAS macros
Build up Standard SAS Macro Toolset with close user collaboration
Enhance & Maintain Table and Listing creation SAS Macro Framework
Integration of Two Table and Listing Frameworks into one
Data & Program transfer project (Windows to Unix including new structures)
SAS Macro Development coordination for Global Biostatistics
SAS Version upgrading for SAS macro frameworks
Continuous user focus for processes and tools
Meeting app developments similar to PhUSE app which I have created
Narrative automation support
WebApp for interactive tables and listings