• Improving Influence and Increasing Impact: Essential Skills for Industry Statisticians

    Slough | Dates: 21 – 21 Sep, 2017

    Presented by

          Andy Grieve, Gemma Hodgson, Margaret Jones (& external speaker tbc)

    The landscape is changing across the pharma industry and as statisticians, in order to continually add value, we must make sure we adapt. This course will focus on what this means for statisticians outside the technical aspects of their role. Of critical importance is self-awareness during our interactions, working effectively in teams, influencing, being customer focussed and understanding our own consulting and leadership styles.

    Now more than ever we need to be creative and influential thinkers with business acumen who can work with our colleagues from other disciplines, not just be technical experts - we need to be proactive partners with strong communication skills.

    This course will lead participants, in a non-threatening and encouraging atmosphere, through the process of understanding their own strengths and weaknesses and what this means when working as a strategic partner or as part of a larger team. It will include workshops to practice the skills and behaviours discussed.

    This course is aimed at statisticians who want to improve their consultancy style interactions within their internal project teams and/or with external customers and understand the impact of their own behaviours and interaction preferences.

    The following topics will be covered:
    • Myer-Briggs profiling and interactions preferences
    • Effective Team working
    • What does it mean to be a consultant?
    • Questioning styles
    • Effective Communication Skills
    • Owning your own development

    Course runs from: 10:00 - 17:00 (registration from 09:30)



    Registration Costs (includes lunch and refreshments):

    PSI Members £345 + VAT
    Non-members £425 + VAT (includes PSI membership for 1 year)

    PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible.  Please help us to help you by letting us know if you require additional facilities or have any special requirements.  Please contact us on +44 (0)845 180349 or at PSI@mci-group.com for further information.
  • PSI Webinar: Measuring Patient and Physician Benefit–Risk Preferences in Antipsychotic Clinical Trials

    Dates: 26 – 26 Sep, 2017

    Tuesday 26th September 2017
    3:00-4:00pm (UK Time)

    Organised by the Benefit-Risk Special Interest Group

    Recently, we shared an example of adopting benefit risk methodology to schizophrenia studies (click here for more information). Now we are happy to announce that Eva Katz, the epidemiologist behind this nice case study, will give a webinar about it and there will be the possibility to have a discussion around this and how other areas can benefit from it.

    Presenter: Eva Katz
    Eva Katz, PhD, MPH, RD is Associate Director of Benefit-Risk and Epidemiology at Janssen Research & Development.  In this role Dr. Katz serves as an internal consultant for benefit‐risk methodology and patient‐focused benefit‐risk assessment, guiding clinical teams across therapeutic areas in medication benefit-risk assessment using both qualitative and quantitative methods.  As part of the efforts to integrate the patient experience in clinical trials, Dr. Katz has helped integrate patient and physician preference surveys within phase 3 clinical trials. Eva also participates in external task forces on benefit‐risk assessment methods and patient focused drug development. Prior to her role in Benefit-Risk, Dr. Katz was part of the patient reported outcomes team at Janssen where she worked cross‐functionally to develop strategy for development, selection and implementation of Patient‐Reported Outcomes (PROs) in phase 2 and phase 3 clinical trials of pharmaceutical products across therapeutic areas. Dr. Katz received her B.S. in Nutritional Science from Rutgers University, her M.P.H. from the University of California, Berkeley and her doctorate in Nutrition Epidemiology from the Gillings School of Global Public Health, University of North Carolina, Chapel Hill.

    Please watch for updates as we are organizing the last pieces. 

    Registration is free. Click here to register!

  • PSI One Day Meeting: Estimands – Examples for Statisticians!

    500 Brook Drive | Dates: 27 – 27 Sep, 2017
    As we approach the imminent release of the ICH E9 Addendum, Estimands is moving from a concept to reality with some Regulators already asking “What is your Estimand?”. But where do you start when defining your Estimand? What is the Estimand of interest and to whom? What inter-current events could determine your Estimand and thus your analysis methodology? The PSI Scientific Committee have put together this one day meeting to provide Statisticians with real world examples of how Estimands have been defined. Presenters will give their insight into discussions with colleagues, working groups and regulators and there will be plenty of opportunity to ask your questions on defining an Estimand.

    Please click here to view the flyer.

    The initial agenda is outlined below; a more detailed agenda will follow in due course.

    Estimands and Sensitivity Analyses: What’s in the new ICH E9 Addendum? Chrissie Fletcher (Amgen)
    The Estimands Concept - Experiences when Introducing the Concept in a Global Development Organization Christoph Gerlinger (Bayer)
    Disentangling Estimands and the Intention-to-Treat Principle Ann-Kristin Leuchs (BfArM) 
    Use of clear estimands - beyond hypothesis testing Yolanda Barbachano (MHRA)
    A Journey Towards Estimand Specification in Pain: Motivation and Challenges Francesca Callegari (Novartis)
    Estimands in Chronic Symptomatic
    Martin Jenkins (AstraZeneca)
    Estimands Examples in Neuroscience - TBC On behalf of the EFSPI working group
    + Others TBC  


     Registration on or before 31st August
     PSI Member 
     £120 (plus VAT) 
     £160 (plus VAT) 
     £60 (plus VAT) 
     Registration after 31st August 
     PSI Member  £160 (plus VAT) 
     Non-Member  £220 (plus VAT) 
     Academic  £90 (plus VAT)

    Please click here to register!
  • Introduction To Industry Training Course 2017

    Dates: 01 Oct, 2017 – 31 Jul, 2018

    Are you a PSI member with approx. 1-3 years experience as a Statistician or a Statistical Programmer within the industry?



    AIM: To describe the drug development process from research right through to research, toxicology, data management & role of the CRO, clinical trials, product development & manufacture and marketing.

    Limited places available!

    Application forms must be received by 30th June 2017!

    Please discuss your application with your manager
    Final dates to be confirmed.


    For further information contact:

    Alex Godwood

    MedImmune Ltd, Milstein Building, Granta Park

    Great Abington, Cambridge, CB21 6GH

    Tel: 0203 7496241

    Email: godwooda@MedImmune.com

  • Statistics Fundamentals for Clinical Trials for Non-Statisticians (or ‘How to speak stats in a day!’)

    Dates: 14 – 14 Nov, 2017

    Presented by
    Gemma Hodgson
    (Qi Statistics Ltd)

    This basic but wide-ranging course covers techniques for investigating, visualising and performing basic statistical techniques on data sets typical to industry settings. There are many basic concepts that need to be understood before statistics can be used to its full potential to give useful and informative answers. This course ensures that these concepts are understood in a non-technical way and then demonstrated using data examples. 

    Mathematical details are kept to a necessary minimum and we focus on the interpretation of statistical output and illustrate applications with data from dummy clinical trials or published data. The objective of the course is not to teach you how to become a statistician, but to help you work with statisticians and get the maximum value from statistical output. 

    The course will consist of lectures, practical examples and discussions. There will not be any computer exercises. 

    Target Audience: 

    This is a 1-day course, aimed to introduce statistics to people who work on Clinical Trials, but who are not Statisticians. No previous knowledge of Statistics is assumed as we start right at the beginning with the basics. Many practical examples are given and the emphasis is on application and understanding rather than the equations and the technical background. 

    The basics of statistics are discussed to give background and a common base to start from and the applications and use of statistics in drug development is then discussed. The role of the statistician and their ability to help with decision making is also discussed. 

    It also serves as a useful refresher course to those who once studied statistics as part of a college course. 

    The following key topics will be addressed: 

    1. Types of Data 

    2. Measures of location and variability 

    3. Basic Inference 

    4. Power calculations and Sample Sizing 

    5. Design Issues 

    For more information on specific topics, please contact the presenter direct on gemma@qistatistics.co.uk

    Please click here to view the flyer.

    About the presenter: 

    Gemma Hodgson, Qi Statistics Ltd. http://www.qistatistics.co.uk 

    Gemma Hodgson has worked in the Pharmaceutical industry for 20 years. After receiving her first degree from Imperial College (Maths with Statistics) and then an MSc in Medical Statistics from London School of Tropical Hygiene and Medicine, Gemma began her career at Pfizer in Sandwich working in experienced global teams on major phase 3 projects. After 13 years at Pfizer and working in all phases of development, from phase 1 to phase 4, Gemma then moved to Takeda R &D in London where she worked on later phase projects, focussing on close liaison with other departments within the organisation. In 2012 Gemma left Takeda to work for a statistical training and consultancy firm, Qi Statistics Ltd, where training of non-statisticians and explaining statistical concepts to non-scientific audiences is key. Gemma has a broad interest in the application of statistics and is an experienced trainer to all types of audience, specialising in translating technical concepts into everyday English.


    Course runs from:            09:45 – 17:00 (registration from 9:15)


    Please register online at www.psiweb.org and click on Events; payment now available online.

    Registration costs (includes lunch and refreshments)

    Registration before 13th October 2017

    £425 plus vat

    Registration on or after 13th October 2017

    £495 plus vat

     Please click here to register

    PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible.  Please help us to help you by letting us know if you require additional facilities or have any special requirements.  Please contact us on +44 (0)1730 715 235 or at PSI@mci-group.com for further information.