Special Adviser, Lead Methodologist in Regulatory and Pharmacoeconomic Statistics, NoMA

Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc on a range of subjects focusing on oncology, immunology and molecular biology, first at the University of Leiden and later at the University of Oslo, before starting at the Norwegian Medicines Agency (NoMA) in 2012.

At NoMA she is working as Special Adviser/Statistician/Methodologist both on regulatory (EMA) and HTA projects. She has been Chair of EMA’s Biostatistics Working Party 2017 - 2019 and from 2019 – 2022 she was Chair of the Scientific Advice Working Party (SAWP) at EMA. She continues currently as alternate member of the SAWP and is Member of the new Methodology Working Party (MWP) recently established at EMA.

Since it was established in 2020 she has been a member of the Big Data Steering Group, working on utilising the full potential of the vast amount of health care data for regulatory decision making.

In her role as Team-leader international HTA (iHTA) at NoMA, she has been heavily involved in EUnetHTA JA3 and its successor, EUnetHTA 21. Her particular focus is on parallel EMA-HTA scientific advices, now in the role as Vice-Chair of the JSC-CSCQ.

She is furthermore involved in several academic and PPP projects as member of Scientific Advisory boards on subjects such as RWD, Patient reported outcomes, rare diseases, paediatric drug development and decentralized trials and digital tools.