Date: Tuesday 19th January 2021 Time: Tues. 19th - 09:00-10:30 GMT Speakers: Melanie Wright (Novartis), Sue McKendrick (PPD), Nanco Hefting (Lundbeck), Rikke Mette Agesen (NovoNordisk), and Helle Lynggaard (NovoNordisk).
Who is this event intended for? Anyone working in clinical trials: Clinician, Regulator, Investigator, Academic, Ethics Committee, Statistician. What is the benefit of attending? Understand how to describe clinical objectives using the estimands framework, recognising the benefits of this approach.
You can now register for this event.
This event is free of charge to both Members and Non Members of PSI. Please note: this event takes place on both the 12th & 19th January, but will entail exactly the same content.
To register for the 12th January session, please click here.
To register for the 19th January session, please click here.
Bringing estimands to life through a real case study. A year on after the final ICH E9 estimands addendum was published, we bring estimands to life from a real example from protocol to press release. Members of the estimands Implementation Working Group (EIWG) will describe the background and study objectives, intercurrent events of interest and chosen estimands in the PIONEER study.
Melanie Wright Novartis
Melanie Wright is a Biostatistics Global Group Head at Novartis Pharma AG. She has an MSc in Biometry from University of Reading (UK) and started working in the pharmaceutical industry in 1996. Despite her background in statistics, Melanie describes herself as “an experienced drug developer with a focus on structured quantitative decision making”. Melanie has been leading many activities as part of the estimand workstream at Novartis for the last 3 years and from last year became involved in the EFSPI/EFPIA estimand working group.
Sue McKendrick PPD
Sue McKendrick is an Associate Statistical Science Director leading the cross-functional Estimand Working Group at PPD. In 1991, she graduated with an M.Sc. in Biometry from University of Reading, UK and has been a Chartered Statistician since 1998. Sue has over 25 years’ experience of statistical consultancy across drug development in both CRO and pharma companies, including collaborating with clinical colleagues on protocol development.
Nanco Hefting Lundbeck
Nanco Hefting is Chief Scientific Specialist in the Clinical Research – Psychiatry department at H. Lundbeck A/S, Copenhagen, Denmark. He has a Master of Science in pharmacy and pharmacist education from the University of Groningen, NL, 1991 and has worked since as a clinical scientist and clinical lead in Clinical Pharmacology and Clinical Development in various companies. Nanco has been involved in the EFSPI/EFPIA estimand working group and is Co-Chair of the EIWG.
Rikke Agesen Novo Nordisk
Rikke Mette Agesen is a Senior International Medical Manager in Global Development at Novo Nordisk. She graduated as a Medical Doctor in 2010 from the University of Copenhagen and has several years of clinical experience within Internal Medicine and Endocrinology. Rikke holds a PhD and a Postdoctoral position in Type 1 diabetes and hypoglycaemia. With a physician’s perspective Rikke represents Novo Nordisk in the EFPIA/EFSPI estimand implementation working group (EIWG).
Helle Lynggaard Novo Nordisk
Helle Lynggaard is a Principal Statistician in Global Development at Novo Nordisk. She obtained her MSc from the University of Aalborg in 1994 and her PhD in 2005 from the University of Copenhagen. She has worked with Novo Nordisk since 1994 in different statistical roles including being a Project Statistician. Since 2015 she has been working in a cross-project biostatistics department that provides support to statisticians in the clinical projects. Helle is a key driver in implementing estimands in Novo Nordisk studies, and is a member of the EFPIA/EFSPI estimand implementation working group (EIWG).
PSI Webinar: Wearable Technologies - Challenges and Opportunities
Wearable technologies and digital health data offer great opportunities for studying patients functionally in real life settings. Actigraphy, for example, can be used as part of clinical trials to collect continuous movement data, but the frequency of data collection results in dense datasets requiring extensive processing and signal detection. In this webinar, a panel of expert speakers will discuss how such aspects can be addressed to help realize the promise of these technologies.
Our annual PSI Medical Statistics Careers Event, will be held online using the Career Fair Plus app on Wednesday 3rd March 2021. The event will include a live online panel discussion and a virtual exhibition session.
Discover your extraordinary potential by working as a Covance AD, Biostatistics / Senior Principal Biostatistician. You will consult in the design of complex and innovative studies & clinical trial programs as well as Leading DMC/DSMB processes.
By joining our company, in this role you will apply your skills and experience in support of developing scientifically based arguments aiming to provide fair accessibility to our company’s drugs and vaccines making a real difference in patient’s lives.
Senior Principal / Principal Biostatistician (Oncology) – FSP
Join our team as a Covance FSP Senior Principal or Principal Biostatistician. You will be assigned to one Sponsor working on Phase I and II oncology studies. Previous Lead experience essential. Office or home-based anywhere in Europe or South Africa.