The Biopharmaceutical Section is excited to launch an Online Training Program that will provide convenient and inexpensive training options for the Section’s members. This program serves as a natural extension of the Section’s Webinar Program that was launched in 2007.
The Online Training Program includes short courses based on professionally recorded videos using a format similar to that used in YouTube videos. The videos can be accessed 24/7 on a computer or even a smartphone. The cost of online training is quite low compared to traditional in-person training, and it can be further reduced by using a group-training format. Up to 25 people can view an online training course with a single registration, which lowers the cost of online training to about $20-25 per person for full-day courses and $10-15 per person for half-day courses.
While the Webinar Program is aimed at shorter two-hour seminars, the Online Training Program supports longer courses that provide in-depth overview of key topics in biopharmaceutical statistics. At the same time, the online training format is quite flexible. Each participant has a seven-day period to watch the videos included in each course at their convenience and select the topics that would be of most interest to them.
The program currently includes three online training courses based on popular short courses offered at numerous conferences around the world:
- Analysis of Longitudinal and Incomplete Data (Full-Day Course), Instructors: Geert Verbeke (Katholieke Universiteit Leuven and Universiteit Hasselt, Belgium), Geert Molenberghs (Universiteit Hasselt and Katholieke Universiteit Leuven, Belgium).
- Key Multiplicity Issues in Clinical Trials (Full-Day Course), Instructor: Alex Dmitrienko (Mediana Inc).
- Statistical Evaluation of Surrogate Endpoints in Clinical Trials (Half-Day Course), Instructor: Geert Molenberghs (Universiteit Hasselt and Katholieke Universiteit Leuven, Belgium).
For more information about the Biopharmaceutical Section’s Online Training Program and to sign up for the individual online courses, please visit the course page
Biostatisticians from industry and academia who have taken advantage of this Online Training Program have provided the following feedback:
For industry statisticians who seek balance between their obligation to fulfill the compendium of critical project responsibilities and their desire to refresh or further develop their knowledge of statistical methods, there is value in having extended access to pre-recorded online short courses in statistics that cover important analytic methods and are of equal caliber as courses offered at major statistics conferences. For biopharmaceutical companies in particular, the ability to grant such online access to groups of statisticians could veritably trigger collaborative learning among peers and enrich the passion for statistics methodology within a department. At UCB BioPharma, our statisticians have offered resounding positive feedback on the direct impact to their projects gained through taking the online course on “Key Multiplicity Issues in Clinical Trials”.
Dr. Abie Ekangaki, Head, Global Statistical Sciences, UCB BioPharma
The online course on multiplicity issues in clinical trials included in the Online Training Program is a must have training for any statisticians dealing with multiplicity problems in design and analysis of clinical trials. The multiple short segment video format provides biostatisticians the flexibility to watch the videos at their convenience and revisit the topics covered at a later time. Slides can be downloaded and be used as a reference guide. The course starts by introducing basic concepts on multiplicity and sources of multiplicity and it gradually builds up to more complex issues. It provides a practical guide on defining hypothesis testing problems, discovering and utilizing structural relationships among hypotheses, and selecting the most optimal procedures among candidate multiple testing procedures. As a statistician with experience in medical diagnostics, medical devices, and the pharmaceutical industry, I found the concepts generalizable to clinical trials in any of these fields. Our team very much enjoyed this course and we highly recommend the Online Training Program to every clinical statistician!
Dr. Farid Jamshidian, Associate Director of Research, Biostatistics, Johnson & Johnson
We have recently completed the online courses on longitudinal data analysis and multiplicity in clinical trials. Overall, it was a good opportunity to increase our exposure to important topics, presented by internationally recognized scholars. The mode of presentation (i.e., online) makes it easy and cost-effective for training among our group: It’s a better use of our training dollars. We also used it as an opportunity to network with other biostatisticians locally working (on our university campus and in our local health authority) in applied clinical research given that the course was licensed for up to 25 people.
I had to contact the online training vendor on a few occasions regarding activation and technical issues, and each time they were very responsive. We purchased the two courses we were interested in at the same time, and had them activated later on when we had set the date with our participants.
Dr. Cynthia Westerhout, Associate Director (Research & Strategic Planning), Canadian VIGOUR Centre, University of Alberta
Recently our statisticians (about a group of 20) have completed the online training course on multiplicity in clinical trials. This online course offers a great deal of flexibility and convenience for training. And it is a cost-effective alternative to the traditional instructor-led training. Even though our statisticians have very busy and different schedules, with the materials/videos accessible 24/7, they were able to find time to learn at a pace that best fit with their individual schedule. Because the course is composed of multiple short segments of videos, some people spent a couple of hours a day to learn over a week, some were able to do it in one or two settings (one day or two half days). Our colleagues in Japan were able to access the web link without any problems. I myself thoroughly enjoyed the course and appreciated the opportunity to systematically review the methodologies available on handling multiplicity in clinical trials for controlling family-wise type I error rate and their power implications. Would highly recommend!
Dr. Jane Xu, Head, Global Data Science, Sunovion Pharmaceuticals Inc
Earlier this year (2017), a group of over 50 statisticians at Gilead expressed interest in attending courses on Longitudinal Data Analysis, Multiplicity Issues, and Surrogate Endpoints sponsored by the Biopharmaceutical Section. The technology was exceedingly easy to use and the vendor was extremely flexible with regard to timing of training. Because we were making these three trainings options available to a large group that required a commitment of either a half-day or full-day, we did not want to overwhelm our statisticians with too many options at one time. To that end, we were able to work with the vendor and very easily staggered the availability of each course (we organized the availability of the courses such that each one was staggered by 1 month). In addition, each training course was accessible for a 14-day window and attendees could start, stop, and restart as desired. I received very positive feedback regarding these three courses. Attendees really liked the fact that they could view the material at their own pace during the 14-day availability window. Statisticians who attended the training indicated the material was easy to follow, appropriate for the audience, logically presented, and well organized. Furthermore, it was broken down into smaller topics sections (1-2 hours for each section). I believe that this type of targeted instruction is the wave of the future and will provide very effective training at a huge cost-saving. We plan to use this resource in the future and will explore, with the vendor, possible options in which the video material is available for longer than 14 days.
Dr. Neby Bekele, Vice President, Biometrics, Gilead Sciences
The online training course options provided by the ASA Biopharmaceutical Section is a great idea. Our team took the Multiplicity training seminar, and it was great experience for all involved and very beneficial in many ways. It provided us the ability to share the challenges we face as statisticians in clinical trial design and data analysis with our non-statistician colleagues in a very non-intimidating supportive environment. We were able to put the presentation on pause and take periods of time to discuss our current challenges real-time and talk about potential strategies. This would not have been possible in a class room setting as it would be a challenge to get our non-statistician colleagues to attend this type of training and express their thoughts in a room full of statisticians with whom they were not familiar. Finally, this was an extremely cost-effective and time-efficient way to gain knowledge with the ability to solidify what was obtained with the convenience of reviewing the information over and over again for up to 30 days.
Dr. Anthony Homer, Biostatistics, PPMH Global Franchise Head, Sanofi
We used the online training program in various situations for the statisticians at Bayer and received very positive feedback. We completed the training course on multiplicity in a large group of statisticians in a meeting format. The pausing of the video offers the possibility for breaks, but above all very fruitful discussions in-between. Afterwards, depending on everyone’s own interest, an individual reworking with the online training course was possible. Furthermore, the program is used successfully for statisticians new to the pharmaceutical industry in order to offer training on these topics in a very flexible format in addition to the usual familiarization phase in the department.
This excellent training offers more than just a good insight into the topics. The introduction to multiplicity issues is suitable for beginners. The further structure provides users as well as experts with a lot of relevant information, so that it can impart knowledge for broad spectrum of statisticians with different backgrounds. Special emphasis is put on the application and implementation. This is accomplished by realistic examples, which run through the course like a thread. The technical handling is easy and comfortable, so that the training can be started at any time and without any delay.
Hermann Kulmann, Head within Pharmaceuticals Statistics, Bayer, Germany
Christoph Muysers, Group Leader within Pharmaceuticals Statistics, Bayer, Germany