PSI Journal Club: Limitations and Challenges with Mixed Model Repeated Measures (MMRM) Analysis
Moses Mwangi and Florian Lasch present their recent work on MMRM, with discussion lead by Geert Molenberghs.
Conference Chair: Sarah Williams
(Roche)
Conference Vice Chair:
David Lawrence
(Novartis)
Amitava Mukhopadhyay
(MorphoSys AG)
Ian Wadsworth
(Phastar)
Jennifer Gilbride
(Bayer)
Julia Niewczas
(AstraZeneca)
Julia Saperia
(MHRA)
Kate Taylor
(Amgen)
Kristina Weber
(Roche)
Maria Efstathiou
(IQVIA)
Martin Jenkins
(AstraZeneca)
Paul Terrill
(PT Stat Consulting Ltd)
Russell Jones
(Calliditas Therapeutics)
Sue Todd
(Reading University)
Teodora Trasieva
(AstraZeneca)
Tobias Mütze
(Novartis)
Tom Burnett
(Bath University)
Vicky Marriott
(PHASTAR)
After completing his PhD in statistics Paul started his career working as a statistician in the agrochemical industry at Jealott’s Hill, Berkshire before becoming a statistical trainer for SAS. He moved into the pharmaceutical industry in 2005 and primarily provides support to biotech and small pharmaceutical companies who lack in-house statistical expertise. Paul has been on the PSI Scientific Committee since 2014, was Scientific Committee chair and PSI Board Member from October 2017 to June 2019 and was the 2021 PSI Conference Chair. Paul has been a member of the EFSPI/EFPIA Estimand Implementation Working Group since 2020. Outside of work Paul enjoys running and archery.
David currently works for Novartis in Switzerland. Previously he worked in various statistician roles of increasing responsibility in clinical trials in both academia and industry and across various disease areas including oncology, respiratory, cardio-renal and ophthalmology. He received a BA and MPhil from the University of Cambridge and has a PhD in Epidemiology from the University of Edinburgh. David has been a member of the Scientific Committee since 2014. Outside of work he is kept busy by two young children.
Rachael is Director and a Principal Statistician at Adelphi Values Patient Centered outcomes team, focused on the analysis and interpretation of PRO data in clinical trials. Previously Rachael has worked as a freelance consultant statistician and prior to that worked at AstraZeneca for sixteen years, including as a clinical trial statistician on phase III-IV oncology projects. Rachael has been a member of the PSI Scientific Committee since 2016, and a PSI Board Member and chair of Scientific Committee since June 2019. Outside of work she enjoys time with her family (husband and two sons) and loves fell running.
Amitava is a Biostatistician at MorphoSys AG, Germany. He has worked for more than eighteen years in pharmaceutical industry across all phases of clinical trials in several therapeutic areas especially, in Oncology, Osteoporosis, Cardiovascular, Infectious diseases. Previously, he has also worked at Novartis, Cytel and IQVIA. Being passionate in science, Amitava has continued his research as a post-doctoral fellow after receiving his PhD degree in modelling. He has been engaged with PSI Scientific Committee since 2018.
Jennifer is a Principal Statistician at Bayer (in Reading, UK) and joined Bayer in 2022. Jennifer has worked in Biometrics for more than 25 years. During her career she has worked mainly in late phase and in several therapeutic areas, most recently Lupus Nephritis, Rheumatoid Arthritis and Pain. Jennifer completed her first degree in Mathematics and Economics at the University of Durham, followed by a MSc in Applied Statistics from Sheffield Hallam University.
Jennifer joined the Scientific Committee in 2014 and has enjoyed working with the team on conferences, one day events and webinars.
Outside of work Jennifer enjoys walking, travel, good food and time with family and friends.
Julia is a Statistical Science Associate Director in Late Oncology Biometrics team at AstraZeneca. Previously she worked in statistical methodology teams at Janssen and AstraZeneca. Her areas of expertise include adaptive and group sequential designs, and multiplicity. She is interested in Bayesian topics of inclusion of external data. She received her BSc and MSc at Lancaster University in the UK and holds a PhD in Biostatistics from Medical University of Vienna. Julia joined the PSI Scientific Committee in 2020.
Julia joined the PSI Scientific Committee in 2020.
Julia is a statistical assessor at the Medicines and Healthcare products Regulatory Agency, where she has been working since 2012. She works across therapeutic areas and enjoys the variety and challenges. She completed her MSc in Statistics with Applications in Medicine from the University of Southampton in 2003 and between then and starting at the MHRA she has worked as a statistician and systematic reviewer in academia and in the public sector. She joined the PSI scientific committee in 2016. In her spare time -- oh, wait, what is that again? -- she sings (quite well) and plays the violin (very badly).
Kristina is a Principal Statistical Scientist at Roche, where she works primarily on late phase Neuroscience studies since 2018. She has previously worked as a statistician at the Medical School Hannover, Germany, where she worked on clinical trials across different indications and development phases. Kristina holds a PhD from the Medical School Hannover and holds a BSc and MSc in Mathematics. She has joined the PSI Scientific Committee beginning of 2020.
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Martin Jenkins is a Biometrics Team Leader at AstraZeneca in Cambridge. He is the statistical lead for several late stage product teams in the respiratory therapy area, and also has experience in rheumatology, dermatology and inflammatory diseases. Martin initially joined AstraZeneca in 2006, providing statistical support to translational science before moving into later phase clinical trials. He has been a member of the PSI scientific committee since 2017 and prior to that chaired the PSI Biomarker Special Interest Group for 6 years. He has published or presented in the fields of adaptive phase II/III seamless designs, biomarkers and estimands. Martin holds a undergraduate degree and masters in Mathematics from Cambridge University.
Since completing her MSc in Medical Statistics, Rosie has worked as a Statistician at Numerus UK and IQVIA before joining Parexel as a Senior Statistician. Rosie joined the Scientific Committee in October 2018. Outside of work, Rosie enjoys playing the drums.
Russell is Head of Biometrics at Calliditas Therapeutics. After an honours degree in Mathematics he spent a few years teaching secondary mathematics with varying outcomes. The result of which led to him undertaking an MSc in Statistics at Southampton in 2006. Since then he has worked in varied areas of Clinical Biostatistics with particular interest in missing data topics. He has been a member of the PSI Scientific Committee since 2011.
Sarah is a Senior Statistical Scientist at Roche, where she has worked for the past 17 years. She has previously worked in the following therapeutic areas: inflammation, oncology and currently works in infectious diseases.
Sarah joined the Scientific Committee in October 2017 and is enjoying getting to know the committee members and helping to organise events.
Outside of work Sarah enjoys running, yoga and days out with her family.
Sue is Professor of Medical Statistics within the Department of Mathematics and Statistics at the University of Reading and has over 25 years’ experience as an applied academic statistician working in the fields of clinical trials and epidemiology. Her particular research areas of interest are adaptive designs and sequential clinical trials. Recent research has considered methodology for novel study design and analysis in these areas, in particular multi-arm multi-stage clinical trials involving treatment selection and multiple endpoints of interest.
Tobias is a statistical methodologist at Novartis in Basel, Switzerland, and works primarily on late phase studies. Previously, Tobias worked as a CMC statistician in the development of vaccines and biologicals. His current research interests are adaptive clinical trial designs, recurrent event modelling, estimands, and more recently missing data methodology. He received his PhD in the area of biostatistics from the University of Göttingen, Germany, and holds a BSc and a MSc in mathematics. Tobias joined the PSI Scientific Committee in January 2019.
Tom is a Lecturer in Statistics at the University of Bath. Prior to this he spent time as a postdoctoral researcher at the MRC Biostatistics Unit at the University of Cambridge and the Medical and Pharmaceutical Statistics unit at Lancaster University. His research focus is adaptive designs for clinical trials, with a primary interest in optimal decision making methods suitable for late phase trials
Kate is a Biostatistics Senior Manager working for Amgen in their Uxbridge office, where she has been for the last 8 years. During that time, she has worked across a number of disease areas and phases in their oncology pipeline. She has also worked in a CRO and completed a placement year at GSK as well as working in market research for a number of years. Kate has been a member of the PSI Scientific Committee since 2016 and was the Conference Chair and a board member for 2019 and 2020. She was also a part of the PSI CALC group for 2 years. Outside of work she enjoys spending time with family and friends and also loves baking and running.
Teodora is a Statistical Science Associate Director at AstraZeneca based in Gothenburg. She joined the company in 2015 after obtaining a MSc in Applied Statistics from Örebro University, Sweden and has worked predominantly on immunology late-stage clinical trials. She also did a secondment in the trial design methodology centre at AstraZeneca, where she consulted on trial design issues in oncology studies with focus on group sequential design and multiplicity. Teodora joined the PSI scientific committee in 2021.
Ian is a Principal Statistician at Phastar, where he has mainly worked on late phase oncology studies since 2018. Prior to this, Ian worked at Lancaster University as a Research Associate in medical statistics for six years. Whilst in this role, Ian studied part-time for a PhD in Statistics looking at extrapolation in paediatric medicine development. Before PhD, he studied for a BSc in Mathematics and MSc in Statistics, also at Lancaster University. Ian joined the PSI scientific committee mid-2022.
Vicky is currently the Head of Statistics at PHASTAR. Prior to that, she has worked at a mix of small and large CROs, as well as at Boehringer Ingelheim. Starting as a graduate statistician, she has gradually moved from a project statistician role to a management role and is passionate about supporting training and career progression within the industry. She was on the PSI CALC committee for 10 years and was on the PSI board as the chair of the CALC group. Outside of work, she enjoys spending time with friends and family, CrossFit and reading.
Moses Mwangi and Florian Lasch present their recent work on MMRM, with discussion lead by Geert Molenberghs.
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