Data Transparency SIG


To share experiences and challenges of external patient level data sharing with particular focus on data privacy and anonymization processes.

Who we are

The Data Transparency SIG is a group of statisticians from industry and academia, with experience and interests in clinical trial data transparency and the associated challenges of patient data anonymization. This includes statistical methods supporting quantitative risk assessment and the privacy aspects of open publication of clinical documents in accordance with evolving regulatory requirements (e.g. EMA Policy 0070, Health Canada and FDA).

How to get in touch

Anyone wishing to join this SIG should contact Rebecca Sudlow (

Latest News

Since the SIGs inception in 2014 we have published a number of articles and held webinars and presentations on these topics. Links to the these are provided below.

Publications: Data sharing in pharma, includes articles on:

  • Statistical guidance for responsible data sharing: an overview,
  • Protecting patient privacy when sharing patient-level data from clinical trials,
  • Best practice for analysis of shared clinical trial data,
  • EFSPI/PSI working group on data sharing: accessing and working with pharmaceutical clinical trial patient level datasets – a primer for academic researchers,
  • Data sharing and the evolving role of statisticians


PSI Webinar recordings - Anonymising Clinical Data, Data Sharing and Data Privacy – what every statistician needs to know

PSI Conference 2018 Recordings - Data Sharing in Practice, Novartis journey in implementing CDP including performing a motivated intruder attack

Upcoming Events

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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


Pharm Research Associates

Principal Biostatistician


Autolus Therapeutics

Head of Statistical and Data Innovation as Head of Biometrics



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