Danielle Stephenson

Senior Manager, Statistical Programming

Danielle has supported clinical studies across multiple phases since 2017, spanning SDTM and ADaM datasets, define.xml files, reviewer’s guides, and TFLs for FDA and PMDA submissions. She works in both SAS® and R, with a focus on the clarity, traceability, and rigor that regulated environments demand, and on helping teams deliver careful, high-quality technical work inside complex systems.

Articles and Resources by Danielle

Blog

Submission-Ready R: How Atorus Built and Validated the FDA’s Standard Outputs for Core Safety and Efficacy Deliverables

September 9, 2026

Proof From a Real, Validated Statistical Programming Workflow For directors and VPs of biostatistics, the practical question about open-source R...

Blog

Leading With Intelligence: How AI Is Transforming Modern Project Management 

December 19, 2025

Artificial intelligence has entered the life sciences and CRO world with remarkable speed. Tools that once felt experimental have become a part...

Blog

Real Projects, Real Transition, Really Revolutionary: Transitioning to R for Biometrics Work

September 26, 2023

Introduction  “SAS® vs R” has been a hotly debated topic for over a decade. Initially regarded as a tool for...