Shaping the industry


PSI works to shape the industry by promoting good practice for pharmaceutical statisticians in the scientific literature [1, 2], by promoting the value of statistical insight in the development of medicines with our directory of consultants and by lobbying to increase statistical input in regulatory decisions [3].

 

Our regulatory committee reviews and comments on regulatory guidelines on behalf of industry statisticians. Our special interest groups and working parties are forums for statisticians to share experiences and form guidelines for good practice in their specific areas of expertise.

 
PSI is a member of EFSPI, the European federation of national pharmaceutical statistics bodies and participates through EFSPI in Europe-wide industry discussions.

If you wish to contribute to any of these activities, contact chair@psiweb.org.

EventsFuture Events


  • A PSI Training Course on Improving Influence and Increasing Impact: Communication Skills for Industry Statisticians - Dates: 16 – 16 Sep, 2019

    This 1-day course will lead participants, in a non-threatening and encouraging atmosphere through steps to focus on improving the key skills of making impactful verbal and written communications.
  • PSI Webinar: Adaptive design: updated draft FDA guidance and its implications - Dates: 04 – 04 Jul, 2019

    In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
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Statistics and Statistical Programming Opportunities at MSD

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Statistics at Costello Medical

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Pharm Research Associates

Principal Biostatistician

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Autolus Therapeutics

Head of Statistical and Data Innovation as Head of Biometrics

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Statistician Opportunities in the UK

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