PSI VisSIG Wonderful Wednesday Webinar Series
This is a good opportunity to develop your knowledge by thinking through a practical example, practicing how to apply graphics principles, and developing your coding skills.
The Regulatory European Special Interest Group (ESIG) is probably the longest serving ESIG, although it was predominantly referred to as a committee until the end of 2020. We have a total of 20 members from 8 countries and 17 companies, and our purpose is to co-ordinate regulatory activities across the European Pharmaceutical Statistical community and to engage with European Regulatory statisticians (here is the link to our page). It is probably fair to say that the COVID-19 pandemic has stretched out colleagues in Regulatory Agencies, and as a result we have seen fewer regulatory guidelines being issued (as either draft or final). This has not reduced our activities, though, and here are some key ones coming up:
Jointly with the Biopharmaceutical Section of the American Statistical Association (ASA) we are jointly organising a webinar on Complex Innovative Designs (CID) in practice. This will be held on 21 October (14.00 – 16.00 BST), with speakers from the FDA, Novartis and GSK. If you are interested, then please find further information and a link to the registration page here.
We typically meet annually with both the MHRA statisticians and the EMA Biostatistics Working Party for an exchange of statistical topics important for both regulators and industry. The EMA has scheduled this again for 29 October and asked us and other statistical stakeholder organisations for topics. We indicated that we would like to discuss the Danish Data Analytics Center and the future plans of BSWP to analyse data, decentralised trials and the use of historical / synthetic control arm data, but have not received any further information yet on the agenda of the meeting. We will feed back on this meeting afterwards.
Finally, several of our members were on the scientific and organisational committee for the 6th EFSPI Regulatory Statistics Workshop held online between 13 and 15 September, covering decentralised trials, complex innovative designs and real world data. We hope many of you were amongst the >1000 registered attendees and enjoyed the event.
PSI are running a book club! We will be reading and discussing non-technical books which are relevant to our roles.
Join us to here about some hot topics in the area of adaptive designs and associated methods. There will be a mixture of cutting edge methodology and real world applications. Along with the opportunity for plenty of discussion and sharing of ideas and opinions!
In this event we will hear from expert speakers on the statistical and operational challenges and considerations of decentralised clinical trials, the promise of digital health data and wearable technology, as well the regulatory perspective to such studies
This presentation provides a brief description of the herd protective effects of the oral cholera vaccines, as an example, that have been evaluated for herd protection in various study settings, leveraging the geographic information system (GIS) tools for analyses.
Talks in these webinars will cover general frameworks for app development, regulatory submissions using R and case studies of using R Shiny in both operational and methodological settings.
In just 1 hour, learn about the field of medical statistics and how it plays a crucial role in developing ground-breaking new medicines, vaccines and healthcare products.
The EU regulation on Health Technology Assessment (HTA) is coming into force from 2025! But why should pharmaceutical statisticians care? Join our webinar to find out more…
Our annual PSI Medical Statistics Careers Event, will be held in person at GSK House in Brentford, London on Wednesday 7th December 2022, and will feature live presentations from new starters, a panel discussion with industry representatives, and an exhibition session.
The Apprentice Biostatistician splits their time between working for Parexel and performing studies with a university to obtain a MSc in Statistics over a period of three years.
Manager Biostatistics is responsible, under supervision, to provide statistical support to Medical Affairs (MA) and Health Economics and Outcome Research (HEOR) /Health Technology Assessment (HTA).
For our headquarters in Munich we are seeking highly qualified candidates to apply for Manager Statistical Programming (m/f/x).
As an Apprentice Statistician within Labcorp Drug Development, you will play an integral role in supporting all aspects of study support functions for our testing and development work.