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Statisticians in the Pharmaceutical Industry


Statisticians in the Pharmaceutical Industry (PSI) is a non-profit organisation formed in 1977 which provides a forum for regular discussion of statistics and issues relating to the practice of statistics in the pharmaceutical industry, as well as promoting Good Statistical Practice within the industry. Together with other European statistical organisations, there are approximately 1200 members and five honorary life-members of PSI. Members of PSI are statisticians and statistical programmers working in all areas of the drug development process, including research, pre-clinical, clinical, production, quality control, marketing and market research; as well as academic statisticians, consultants and others interested in the application of statistics within the industry. The majority of members (around 80%) are based in the UK, the remaining 20% from other EU countries and the US. Importantly, PSI is a member of the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI). EFSPI is formally represented in the Board of Directors of PSI, ensuring that through PSI the entire EFPSI network can be involved. EFSPI represents over 2000 statisticians in the pharmaceutical industry in Europe, including global companies.

Both PSI and EFSPI have a proven track record of organising regular international scientific meetings that bring together industry, academia and regulators to advance methodology to improve drug development. Both organisations present newsletters to all its members, have created joint Special Interest Groups and have their own websites (www.psiweb.org and www.efspi.org)

Main tasks

PSI will take the lead in dissemination of the results (WP6) through a dissemination plan which will include at least: a project website, bi-annual leaflets/progress letters, scientific publications, stakeholder meetings and a final ASTERIX conference. Through its connections with EFSPI, PSI will provide the professional platform to organize targeted dissemination activities as well as joint workshops across all stakeholders. PSI will contribute additional case studies to validate the new methodologies in a sufficiently broad perspective and will assist in the assessment of the feasibility of implementation and impact of these methodologies in WP5.

Key personnel

The PI, Dr. Egbert Biesheuvel, is member of PSI as well as chair of the Scientific Committee and current Vice President of EFSPI. He is Director of Late Development Statistics at the pharmaceutical company MSD and is part of senior site management of a large pharmaceutical company. In addition he is chair of the Dutch Pharmaceutical Statistics and Data Management (PSDM) group and member of the Clinical Development Committee of the EFPIA.

Dr. Byron Jones is a member of the Board of Directors of PSI with responsibility for Special Interest Groups and for ASTERIX. He is an Executive Director and Senior Biometrical Fellow in the Statistical Methodology Group at Novartis Pharma AG in Basel, Switzerland.

The team members involved in ASTERIX all have a background in biostatistics, a wide variety of experience within pharmaceutical drug development, as well as working with non-statisticians involved in clinical development and to share ideas, insights and results to a wide variety of disciplines.

Dr. Egbert Biesheuvel
Lead, WP6

Dr. Byron Jones
Researcher, WP6