Introducing
Group Head Of Statistical Methodology at Novartis
She is a consultant in the Statistical Methodology Group of Novartis Pharma AG, based in Basel, Switzerland.
In this role, she provides internal advice for clinical projects across all development phases and therapeutic areas. One key aspect of her work is to make complex statistical problems and methods accessible to a wider audience. In addition, she is engaged in developing and implementing innovative statistical methods for clinical projects. Her role also includes training of internal statisticians and collaborations with external statistical centers and researchers.
Mouna has a wide range of research interests including topics on missing data, longitudinal data, recurrent event data, and dose-finding studies. Before joining Novartis, Mouna studied mathematics at the University of Oldenburg in Germany and holds a PhD in statistics from the University of Warwick in the UK.
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The past, present, and future of estimands!
with Chrisse Fletcher and Mouna Akacha
If you ask someone within the pharma world of statisticians what is the hottest topic, you most likely will just get: Estimands!
Many scientific events, conference sessions, publications, and presentations are organized around this topic. Thus, I’m super happy, that we have Mouna and Chrissie on the podcast as they have presented this topic on various occasions.
In this episode, you will learn about
- the importance of the concept itself and its implications
- the terminology of the estimand framework
- and how it relates to missing data terminology
The episode covers the following questions and gives some examples of the different parts of the framework:
- What is the history of the estimands and how is it related to missing data?
- What is ICH E9 and why does it need an update now?
- What are the different parts of an estimand and how do they relate to each other?
- Is the estimand framework only applicable to clinical trials in the regulatory setting or is this something to be considered beyond the regulatory approval of new medications?
We also cover the PSI conference 2019, which surely will include sessions about estimands as well as the upcoming 1-day event organized by PSI: New Emerging Topics around Estimands and ICH Addendum. Click here to find out more about this event and the registration page.
The ICH E9 (R1) addendum on estimands and sensitivity 5 analysis in clinical trials to the guideline on statistical 6 principles for clinical trials can be found here.
A nice interview with Mouna around estimands as well as a great list of resources was published by Cytel here.
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This group was set up to help each other to become more effective statisticians. We’ll run challenges in this group, e.g. around writing abstracts for conferences or other projects. I’ll also post into this group further content.
I want to help the community of statisticians, data scientists, programmers and other quantitative scientists to be more influential, innovative, and effective. I believe that as a community we can help our research, our regulatory and payer systems, and ultimately physicians and patients take better decisions based on better evidence.
I work to achieve a future in which everyone can access the right evidence in the right format at the right time to make sound decisions.
When my kids are sick, I want to have good evidence to discuss with the physician about the different therapy choices.
When my mother is sick, I want her to understand the evidence and being able to understand it.
When I get sick, I want to find evidence that I can trust and that helps me to have meaningful discussions with my healthcare professionals.
I want to live in a world, where the media reports correctly about medical evidence and in which society distinguishes between fake evidence and real evidence.
Let’s work together to achieve this.
