Dr David Warne is a Consultant Biostatistician with 25 years successful experience in clinical development and the current President of the International Society for Clinical Biostatistics (ISCB). Over the years, he has directed the statistical aspects of phase 1-4 clinical trials, and is an expert in process and quality management.
He is also the Newsletter Editor was the former Secretary for ISCB and is also now an Honorary Member as well as continuing to take an active role with other major societies including the Royal Statistical Society.
Statistics Views talks to Dr Warne about his career in statistics, his work on clinical trials and his current role as President of the ISCB.
1. What was it that first introduced you to statistics as a discipline and what was it that led you to study mathematics and statistics at Warwick?
At the age of 8, I started watching football and doing football statistics, counting floodlights (!) and creating colourful tables of Chester, my local team’s results. I went on to study statistics several times at school for maths exams at 15, 16 (O Levels), 17, 18 (A Levels), perhaps without ever fully understanding it. But being good at maths in general, I chose to study Maths at Warwick, a decision which turned out to be bad and good; bad because I was shocked to find Maths resembled philosophy with few numbers to play with, but good because Warwick allowed people to switch to a variety of joint degrees and I jumped at the chance to study Statistics with a large dose of Operational Research, both very applied subjects. Warwick was a hot bed of Bayesian statistics…
2. You then studied for your MSc in biometry followed by a PhD on Bayesian design and analysis of clinical trials, both at Reading. What were the factors that led to you to decide to focus your career on biostatistics?
At the end of my BSc at Warwick, I knew I’d like to do research, but funding wasn’t available. The next academic year was spent mainly at home with my family as my younger sister recovered from leukaemia instead of starting her BSc in Land Management at Reading. During that year, I reviewed my options and looked at MSc courses in Statistics and I chose… Reading! Reading was an excellent choice, a thriving MSc course and with much research going on, it was a simple choice to stay on after the MSc year (the toughest in my life!). Why biostatistics? That wasn’t the only choice with my peers working on the statistics of sensory testing, experimental design for agricultural research etc. The department did a lot of teaching of statistics, and this is probably where I really learned statistics, and I even found myself teaching my sister and her peers! But having been exposed to a lot of people working in medicine in Chester, Liverpool and Reading, I had a very good reason to focus on medical statistics (biostatistics), and my PhD compared Bayesian and frequentist methods for designing clinical trials.
3. You’ve since worked as a statistician and teacher before moving to Switzerland, first Ciba-Geigy in Basel and later Serono (later Merck Serono) in Geneva where you eventually became Associate Director of Biostatistics for six years, followed by their Global Processes Head for over two years. What are your memories when you look back on your time at (Merck) Serono? What do you feel were your main achievements?
During my studies in Reading, I was lucky enough to spend 3 months in Düsseldorf, West Germany, the summer before Germany reunited. I enjoyed my time so much, despite speaking hardly any German, I decided that I’d like to work abroad. The move from university life to a first job is often hard, but moving to a new country was particularly difficult. I also realised I didn’t know that much about clinical trials or SAS, and learning German wasn’t much use in understanding the people who spoke Swiss-German. After 3 years in Basel working on depression and cancer projects, I was fortunate to find a position at Serono, a small biotech company in Geneva, and the therapeutic area was much more “cheerful”, making babies. From starting as a biostatistician, my career progressed over 12 years with increasing levels of responsibility and some management of people. Highlights were meetings with Health Authorities in London (MHRA), Washington DC (FDA) and Tokyo (PMDA), and getting a range of products for infertility approved, mostly based on equivalence or non inferiority trials.
4. You have worked on various trials and projects over the years on topics such as infertility, endocrinology and rheumatoid arthritis. Is there a particular trial or project that you were most proud of working on?
On one trial of r hCG, I was involved in the design, running, analysis and reporting and finally publication, a rare opportunity to see the whole process through from start in 1995 to finish in 2001.
5. What are your main research interests? Are you working on anything currently?
I still am interested in Bayesian statistics after all these years and was fortunate enough to have the chance to design a trial with Bayesian stopping rules at interim looks in Serono. From my exposure to them, I am still interested in equivalence and non-inferiority studies. The last 4 years, my experiences have broadened as I’ve become involved in working on a much wider variety of studies in different therapeutic areas and also nutrition and medical device trials.
6. You are currently a consultant biostatistician and an Academic Fellow at the University of Geneva. Please could you give us an idea of your every-day work?
Rather than spend 2 hours a day commuting across Geneva, as I did for 18 years, I now take my younger son to school in the morning and work in my attic office. There are sometimes visits to clients, including some in Geneva, Lausanne, and further afield in Switzerland, Europe and even once I spent a week in Hyderabad, India. But usually I’m working at home, reviewing documents and programming analyses mostly in SAS, a program I’ve used for 30 years now. Each week there will be a variable number of meetings help by telephone or video conference. Remote working takes some getting used to, both for yourself but also your family who were not used to you being at home most of the time. After 25 years, I’ve returned to teaching at University of Geneva, giving an “Introduction to Biostatistics” course to an interesting mixture of students doing an MSc Statistics or a PhD in Pharmacy, as well as a module on “Medical Statistics and Trial Methodologies” for a “Master in Advance Studies: Drug Discovery and Clinical Development”.
7. You became an Honorary Member of the International Society for Clinical Biostatistics in 2007 before becoming their current President. How has the society adapted over the years to meet the changing needs of the biostatistics community?
ISCB has grown tremendously as the clinical biostatistics community has grown. In the early days from 1992, when a certain Stephen Senn persuaded me to edit the ISCB News, much communication was done by letter or phone call, and email was still something of a novelty. Since my first conference in Cambridge in 1993 to my 24th and latest in Birmingham in 2016, I’ve been lucky enough to travel to lots of interesting cities across the globe, mainly in Europe but also 2 in Boston and Ottawa. Unlike other societies, ISCB has always focused on its conferences which are a showcase for top quality new biostatistical research, but also a great place to make friends and meet old acquaintances. I’ve seem some research ideas first addressed at some conferences, then seen them being developed and finally the approaches have been “mainstream” way of running trials. In 2006, I was the Chair of the Local Organising for ISCB27 in Geneva and I was involved over 5 years in all stages of the planning, a very rewarding learning experience in many ways.
8. Societies often talk about the struggle to attract young members and retain them throughout their career. What would you say are the benefits of ISCB membership?
I would say ISCB specialises in attracting students to present their research findings in attractive locations at well-run conferences. In the past, it’s possible newcomers might have felt a bit lost at a conference and may not have continued in the Society, but in recent years, the subcommittee for Student Conference Awards has done a great job encouraging people to attend and rewarding the best abstracts, making the conference week memorable and fun with special students’ events, and in 2016, a “Students’ Day” was initiated to allow students to present discuss issues about how they do their research, rather than the research findings themselves. Other than that, ISCB produces a Newsletter twice a year with updates about the Society and its activities, and book reviews from members.
9. The ISCB conference is due to will take place next July in Vigo, Spain and has attracted some big name speakers in recent years. What will the focus be on in 2017? Who should we look out for?
If it ain’t broke, don’t fix it could be ISCB’s motto for conferences! The location changes each year from country to country, but the pattern is very similar with pre-conference courses, invited, contributed and poster sessions, mini-symposia and 2 keynote plenary lectures. The programme design can be found on www.iscb2017.info.
10. What have been the highlights in being President so far?
I wouldn’t say being President was that different from being one of the Society’s Officers, which I did for 6 years, 4 as Secretary and 2 as Vice-President. I’ve chaired a lot of long meetings, in person at the conferences in Utrecht and Birmingham, as well as teleconferences, and addressed a lot of issues. One highlight to mention would be choosing the President’s Invited Speaker for those 2 conferences, another would be agreeing on venues for the next 4 conferences in Vigo (2017, first time in Spain for 22 years), Melbourne (2018, first time in the southern hemisphere), Leuven (2019, first time in Belgium for 28 years) and Krakow (2020, first time in Poland). Please see www.iscb.info for more details.
11. What do you think are the main challenges facing the world of biostatistics todat?
The very need for biostatistics and biostatisticians was a challenge in the early days of ISCB, but I think the world has progressed since then, with much regulatory guidance specifying what has to be done and who has to do it, namely qualified statisticians. But the world isn’t perfect; there are still many countries, indeed continents such as Africa and South America, where statistics in general and biostatistics in particular, are not well known or practised.
12. What has been the best book on statistics that you have ever read?
These days, there are many excellent biostatistics books, but 30 years ago, ones you would like to read and recommend to non-statistical colleagues were pretty rare. Stuart Pocock’s Clinical Trials: A Practical Approach published in 1983 (Wiley-Blackwell. ISBN 978-0-471-90155-6) is still a good read, with only a few aspects having been superseded by modern technology.
13. Who are the people that have been influential in your career?
A few statisticians I recall are Mike West and Jeff Harrison at Warwick – their Bayesian work on time series was inspirational. At Reading, there were many excellent biostatisticians almost too many to mention, but I’d like to mention Derek Pyke, Robert Curnow, John and Anne Whitehead who helped me to learn to be a biostatistician. Stephen Senn had a big impact when he came to RSS meetings in the late 80s and early 90s, and I was lucky to meet him in Basel shortly after completing my PhD. I have to say it’s mostly not the biostatistical interactions I remember, but the more “human” aspects I recall.
14. If you had not got involved in the field of statistics, what do you think you would have done? (Is there another field that you could have seen yourself making an impact on?)
I can’t think of anything. My career has progressed based on my interests and a lot of random variation, nothing was planned, but I’ve somehow ended up at a good endpoint!
Copyright: Image appears courtesy of Dr Warne