Community Spotlight

The DIA Statistics Community:
Getting the Questions Right Through Collaboration

Yeh-Fong Chen
Mathematical Statistician, Team Leader,
FDA, CDER, Office of Biostatistics, Division of Biometrics 3

Yeh-Fong Chen
Mathematical Statistician, Team Leader,
FDA, CDER, Office of Biostatistics, Division of Biometrics 3

Matt Baldwin
Senior Biostatistician,
PRA Health Sciences


he DIA Statistics Community is a vibrant and active global group that supports a community of practice for statisticians and professionals who are interested in statistics in the biopharmaceutical and healthcare industries, including academic and government sectors. However, what differentiates us from other statistical associations is our focus on collaboration with other disciplines. Statistics methodology is important, and we do touch on it, but having a broader vision for how statistics connects with many other areas in the clinical process is also important. DIA gives statisticians the opportunity to engage with our clinical colleagues – clinical research, pharmacovigilance, regulatory affairs, data standards, study endpoints, patient engagement, and clinical data management, to name a few.

Our mission includes providing global forums forums for the sharing of statistical knowledge and experience, and identifying and responding to the educational and professional development needs of the Community. The community offers many benefits to its members, including All-Hands and Virtual Journal Club (VJC) meetings in a wide variety of hot statistical and cross-functional topics. These webinars are all archived creating a rich library of resources for reference. Click here to see our 100+ library entries, including slides and recordings. DIA members have the opportunity to keep abreast of FDA guidances, revisions to ICH guidances and innovative designs and analyses in pre-clinical and clinical trials. Networking with like-minded colleagues in the industry is also an often-overlooked benefit of this type of community. We are always in need of new ideas and engaged members, so join us today!

Members of our Community can participate in the high-quality, timely, relevant webinars that are at no additional cost to DIA members. We can achieve this because the Community leadership, our core committee, is composed of statisticians with many years of experience – professionals who truly care about the statistics community and see the importance of cross-disciplinary dialogue to achieve better medicines for patients. We have received continued support from our global leaders including Jerry Schindler (DIA Statistics Global Chair; Alkermes), Joan Buenconsejo (DIA Statistics Community Chair, North America; AstraZeneca), Jürgen Kübler (DIA Statistics Community Chair, Europe; QSciCon), Tony Guo (DIA Statistics Community Chair, China; Beigene) and Steve Wilson (consultant, formerly CDER/FDA), as well as DIA staff.

In addition to the names above, the core members also include Matt Baldwin (PRA Health Sciences), Bruce Binkowitz (Shionogi), Yeh-Fong Chen (CDER/FDA), Brenda Crowe (Lilly), Susan Duke (CDER/FDA), Jon Haddad (GSK), Munish Mehra (Tigermed), Qi Tang (Sanofi), Bill Wang (Merck), and Susan Wang (Boehringer Ingelheim).

What Have We Accomplished?

DIA offers many excellent opportunities for Community members around the globe. For example, many of our members are involved in leadership and participation in the annual meeting of the DIA Statistics Community, the DIA/FDA Biostatistics Industry and Regulator Forum, an event focused on statistical thinking to inform policy, regulation, development, and review of medical products in the context of the current scientific and regulatory environments, including pharmaceuticals, biologics and biosimilars, combination products and devices, and generics. In similar fashion, our community encourages participation as attendees, speakers and session chairs in many global conferences including DIA Global Annual Meeting, DIA China Annual Meeting and DIA Europe.

In addition to these conferences, we have also conducted regular All-Hands and VJC meetings. The essence of VJC is simply to choose an article from the Therapeutic Innovation & Regulatory Science (TIRS) journal and ask the author(s) and a discussant to present the content in a webinar. Recent VJC topics have included “Clinical Trial Safety Monitoring” and “Novel Designs in Dose Finding.” All-Hands meetings have various definitions depending on who you ask. We often use them as a platform to bring in speakers on current topics via webinars. We decided to go with a theme in 2018, developing a six-part webinar series titled “Getting the Questions Right,” which seeks to explain how the concept of an estimand warrants consideration on use in everyday working, not left on the sidelines as an esoteric statistical concept. The desire is to create discussions so that people understand what estimands are, how to begin using them, and how they matter to science and patients.

We are collaborating with the Patient Engagement, Regulatory Affairs, Study Endpoints, Clinical Research, Clinical Safety & Pharmacovigilance, and Clinical Data Management communities, as well as the DIA/ASA Biopharma Safety Assessment WG. The series of webinars discusses concept, solutions, and case studies to improve transparency and ensure alignment between trial objectives and statistical approaches in clinical trials. The series title “Getting the Questions Right” targets the core objective of clinical development. While the series will refer to the draft addendum to the main statistical guidance in drug development, ICH E9, the full implementation requires a cross-functional effort. This series is, therefore, designed and run as a cross-community event with a goal of opening the dialogue across multi-disciplinary functions. The topics include: “Where to Begin?” (slides, recording, Q&A), “Case Studies in the Respiratory Setting” (slides, recording), “Safety-Enabled Benefit Risk” (slides, recording), “Case Studies in the Alzheimer’s Setting” (Sep 2018), “Advancing Interpretation” (Oct 2018), and “Next Steps” (Dec 2018).


Guan Xin

I have been a DIA member for multiple years and I regret that I didn’t join the association earlier. The membership has been a tremendous benefit professionally and personally. Here, I learn the frontier knowledge of drug development, study design, statistical analysis and regulatory policy through attending forums and working groups organized by DIA and reading whitepapers and DIA journal Therapeutic Innovation and Regulatory Science.  After I joined the Virtual Journal Club of the Statistics Community as a member of the committee, I have been involved in organizing and hosting multiple journal club meetings. It gave me the opportunity to work with many renowned statisticians, learn from them and expand my professional network. I would recommend everyone working in biopharmaceutical industry join.

Yeh-Fong Chen

I greatly appreciate the numerous opportunities that DIA has offered me for my professional development. My involvement in the DIA annual meeting was initially through the introduction of Dr. Steve Wilson, a former division director at FDA. He reviewed my first abstract, and I learned a lot from him about how to write an outstanding abstract for the DIA annual meeting. Under his supervision, I eventually chaired a session at DIA, and it was a great success. With his encouragement, I continued to submit session abstracts to the DIA annual meeting over the years. In 2009, Dr. Joan Buenconsejo, a team leader at FDA, connected me with Dr. Tad Archambault and Ms. Susan Duke. Since then, we have jointly led the DIA Statistical Virtual Journal Club.

About four years ago, Dr. Buenconsejo and Ms. Duke invited me to join the DIA statistical core committee. Being a committee member, I have met many distinguished statistical leaders from the US and worldwide including EU and China. Through the activities led by the committee, I had opportunities to make friends with young statisticians and encourage them to join our committee.

I am honored to be the statistical track core chair in the DIA 2018 Annual Meeting. The many days and hours that we spent on meeting and planning have ultimately led to a very successful and informative DIA annual meeting. I would like to extend a big welcome to the fellow statisticians who have decided to get involved in DIA activities and join different DIA communities. I assure you that you will benefit a lot not
only from the work-related perspective but also from the life perspective.