title: Data sharing and the evolving role of statisticians.
abstract: BACKGROUND
  Greater transparency and, in particular, sharing of clinical study reports and patient level data for further research is an increasingly important topic for the pharmaceutical and biotechnology industry and other organisations who sponsor and conduct clinical research as well as academic researchers and patient advocacy groups. Statisticians are ambassadors for data sharing and are central to its success. They play an integral role in data sharing discussions within their companies and also externally helping to shape policy and processes while providing input into practical solutions to aid data sharing. Data sharing is generating changes in the required profile for statisticians in the pharmaceutical and biotechnology industry, as well as academic institutions and patient advocacy groups.
  
  
  CONCLUSIONS
  Successful statisticians need to possess many qualities required in today's pharmaceutical environment such as collaboration, diplomacy, written and oral skills and an ability to be responsive; they are also knowledgeable when debating strategy and analytical techniques. However, increasing data transparency will require statisticians to evolve and learn new skills and behaviours during their career which may not have been an accepted part of the traditional role. Statisticians will move from being the gate-keepers of data to be data facilitators. To adapt successfully to this new environment, the role of the statistician is likely to be broader, including defining new responsibilities that lie beyond the boundaries of the traditional role. Statisticians should understand how data transparency can benefit them and the potential strategic advantage it can bring and be fully aware of the pharmaceutical and biotechnology industry commitments to data transparency and the policies within their company or research institute in addition to focusing on reviewing requests and provisioning data. Data transparency will evolve the role of statisticians within the pharmaceutical and biotechnology industry, academia and research bodies to a level which may not have been an accepted part of their traditional role or career. In the future, skills will be required to manage challenges arising from data sharing; statisticians will need strong scientific and statistical guiding principles for reanalysis and supplementary analyses based on researchers' requests, have enhanced consultancy skills, in particular the ability to defend good statistical practice in the face of criticism and the ability to critique methods of analysis. Statisticians will also require expertise in data privacy regulations, data redaction and anonymisation and be able to assess the probability of re-identification, an ability to understand analyses conducted by researchers and recognise why such analyses may propose different results compared to the original analyses. Bringing these skills to the implementation of data sharing and interpretation of the results will help to maximise the value of shared data while guarding against misleading conclusions.
authors.affiliation: Amgen Ltd., 240 Cambridge Science Park, Cambridge, CB4 0WD, UK. nick.manamley@amgen.com.
authors.forename: Nick
authors.initials: N
authors.lastname: Manamley
authors.affiliation: GlaxoSmithkline, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex, UB11 1BT, UK.
authors.forename: Steve
authors.initials: S
authors.lastname: Mallett
authors.affiliation: MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London, UK.|MRC London Hub for Trials Methodology, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Sydes
authors.affiliation: AstraZeneca, Alderley Park, Cheshire, SK10 4TG, UK.|Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester Academic Health Science Centre, Oxford Road, Manchester, M13 9PL, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Hollis
authors.affiliation: Vectura, One Prospect West, Chippenham, Wiltshire, SN14 6FH, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Scrimgeour
authors.affiliation: Hoffman-La Roche, Grenzacherstrasse 124, Basel, 4070, Switzerland.
authors.forename: Hans Ulrich
authors.initials: HU
authors.lastname: Burger
authors.affiliation: Hoffman-La Roche, Grenzacherstrasse 124, Basel, 4070, Switzerland.
authors.forename: Hans-Joerg
authors.initials: HJ
authors.lastname: Urban
mesh_terms: D006801:Humans; D033181:Information Dissemination; D024382:Professional Role; D013223:Statistics as Topic
keywords: Academic research; Biotechnology research; Clinical trial; Data sharing; Pharmaceutical research; Statistician; Transparency