Dr. Jie Chen Dr. Colin Wu
1. Dr. Chen, Jie
[PRESENT POSITION] Distinguished Scientist, Biostatistics and Research Decision Sciences, Merck Research Laboratories, Merck & Co., Inc., North Wales, Pennsylvania, USA (2017 – present).
[JOINT APPOINTMENTS] Visiting Member, Center for Innovative Study Design, Stanford University, 2017—present; Adjunct faculty, Department of Statistical Science, Temple University, 2017—present.
[FORMER POSITIONS] Sr. Global Group Head, Global Biostatistics and Pharmacometrics, Novartis (2015 – 2017); Senior Director, Head of Biometrics and Information Sciences, AstraZeneca Global Medicines Development China (2014 – 2015); Director/Senior Director, Head of Biostatistics and Statistical Programming, Merck Serono Beijing R&D Hub (2010 – 2014); Director of Statistics, Pharmacoepidemiology, Global Medical Services, Abbott Laboratories (2009 – 2010); Biometrician, Sr. Biometrician, Associate Director, Biostatistics and Research Decision Sciences, Merck Research Laboratories, Merck & Co., Inc., North Wales, Pennsylvania, USA.
[DEGREES] Ph.D. in Statistics, Temple University, 2003; M.P.H in Biostatistics, University of Oklahoma Health Sciences Center, 1994; and B.M., School of Public Health, Shanghai First College of Medicine (Now Fudan University School of Public Health), Shanghai, China, 1984.
[FIELD OF MAJOR STATISTICAL ACTIVITIES] Biopharmaceutical Statistics, Clinical Trials, Medical Product Safety, Multiple Comparison and Multiple Testing, Sequential Analysis, Real-World Data and Evidence, Causal inference, Multi-Regional Clinical Trials, Benefit-Risk Assessment, Bayesian Analysis.
[ICSA ACTIVITIES] Board of Directors of ICSA, 2017—present; Award Committee of ICSA, 2018—present; Organizers of invited sessions at several ICSA Applied Statistics Symposia; Member of ICSA, 2008—present.
[HONORS AND AWARDS] Best Student Paper Award, Biopharmaceutical Section of the American Statistical Association, 2003; Graduate Research Fellowship, University of Oklahoma Health Sciences Center, 1992—1994.
[EDITORIAL SERVICES] Co-Guest Editor, Statistics in Biopharmaceutical Research, 2010, 2013; Co-Guest Editor, Journal Biopharmaceutical Statistics, 2013; Co-Guest Editor, Biometrical Journal, 2007;
[PROFESSIONAL SERVICES] President, the International Society for Biopharmaceutical Statistics, 2008—present; Co-chair, Scientific Program Committee, the 6th International Symposium on Biopharmaceutical Statistics, Kyoto, Japan, 2019; Scientific Program Committee, CEN-ISBS Joint Symposium, 2017; Organizing Committee, UMBC-Stanford Workshop on Clinical Trials and Regulatory Sciences, 2016—2018; Organizing Committee, Stanford Center at Peking University (SCPKU) Workshop on Biomedical Innovation and Regulatory Sciences, 2017—2018; Executive Committee, the 1st, 2nd, 3rd, 4th and 5th International Symposia on Biopharmaceutical Statistics, 2008—2017; Steering Committee, ASA/Biopharmaceutical Section Regulatory-Industry Statistics Workshop, 2010; Management Committee, Current Index to Statistics, ASA, 2008—2010; Organizing Committee, The 5th International Conference on Multiple Comparison Procedures, 2009; Co-Organizer, the 4th International Conference on Multiple Comparison Procedures, 2005; Serving as referees for more than 10 statistics journals (e.g., The American Statistician, Biometrics, Communication in Statistics—Theory and Methods, Journal of Biopharmaceutical Statistics, Journal of Statistical Planning and Inference, Journal of Infection and Public Health, Statistics in Biopharmaceutical Research, Statistics in Medicine, etc.) In addition, Jie has given short courses on statistical applications in medical product development and regulation at many statistical conferences including the ASA/Biopharmaceutical Section Regulatory-Industry Statistics Workshop (2010), EMA (European Medicines Agency) Statistics Workshop (2011), and JSM (2017).
[SELECTED PUBLICATIONS] Jie has published one co-authored book (one more forthcoming in 2020), one book chapter, and over 30 peer-reviewed research papers in a wide range of journals such as Journal of Statistical Planning and Inference, Statistics in Medicine, Journal of Biopharmaceutical Statistics, Computational Statistics and Data Analysis, Encyclopedia of Biopharmaceutical Statistics, American Journal of Epidemiology, Clinical Pharmacology and Therapeutics, Therapeutic Innovation and Regulatory Science, Drug Information Journal, Medical Safety and Global Health, Journal of Virological Methods. The co-authored book is entitled Medical Product Safety Evaluation—Biological Models and Statistical Methods (Chapman & Hall/CRC Press, 2018), and the forthcoming co-authored book Real-World Data and Evidence—An Interdisciplinary Approach and Applications to Precision Medicine and Healthcare (Chapman & Hall/CRC Press, 2020).
[STATEMENT] I feel very honored and grateful to be nominated by the ICSA Nomination and Election Committee as a candidate for the President of ICSA to which I am proud of being a member for more than a decade, serving its Board of Directors (2017—2019) and Award Committee (2018–present), and being engaged in its many other activities.
As a statistical methodologist working in the biopharmaceutical industry, I have always felt that being part of a coherent, educational, scholastic, and respectful organization is so critical for everyone’s professional life. ICSA, the home of ten of thousands of statisticians and quantitative scientists worldwide, is undoubtfully such a prestigious professional organization which, through the tireless effort of its leadership teams and, most importantly, the support from each and everyone of its members, has grown stronger and more charismatic in a broad range of disciplines, especially in the era of big data and data science. The world changes constantly, so does our profession, which brings numerous challenges to our career that demand us to change the ways we used to think, to perform our job, to communicate with others, and to educate ourselves and our younger generations. “To change is difficult, not to change is fatal” [Charles Darwin, 1809—1882]. I have always been thinking of how we can live our professional life adaptively so that we can perform our job better day over day.
With my experience in biopharmaceutical industry and academic community, and in serving ICSA and other organizations, and my greatest passion to our profession, I would, if elected, continue the great effort led by the current leadership team and meanwhile strengthen and promote the following initiatives:
- Strengthening Statistical innovation: Innovation is the driving force for science to advance. Statistical and analytic methodologies that we are using today in drug development and any other fields are much more advanced than the ones we used twenty years ago. Statistical innovations offer much more precise view into science, bringing faster and more accurate development path in virtually every applied fields, especially in the development of medical products for human use. Yet, the constant change of the world demand ceaseless innovations, an example of which is the call of innovative analytic approaches to deriving fit-for-purpose real-world evidence from real-world data for regulatory decision-making. Innovations are motivated by and then applied to solve real-life problems, which necessitates cross-sector (-subject) collaboration.
- Encouraging Collaboration: Collaboration breeds efficiency and productivity, transforming subject knowledge into life-saving products, which demands seamless collaboration in research between statisticians and quantitative scientists across different sectors (e.g., academic, government, industry), different geographical locations, and different disciplines. Collaboration also reflects at organizational level through partnership with other professional societies such as the American Statistical Association. A magnificent goal can only be achieved through collaboration.
- Promoting excellence in communication and leadership: “The best thing about being a statistician is that you get to play in everyone’s backyard” [John W. Tukey, 1915—2000]. Statistics as an applied science has a place in every scientific discipline and statisticians work with scientists in every step toward solving scientific problems, which requires excellent communication skills. On the other hand, statisticians take critical leadership roles in many subject matters such as drug development and regulation. With these eminent needs, the organization can offer opportunities for our members to sharp up their communication and leadership skills.
- Meeting our member’s needs: Our member’s needs are ultimate goals of the organization. The president and its leadership team can reach out to all of our members to ascertain what is important to our member’s career development, how ICSA can better serve our members, how ICSA can better be structured to lead in the changing world. Your voice will be heard!
In summary, I am so excited about the opportunity to support ICSA as president and to work together with its leadership team and our members for continued success of our organization.
2. Dr. Wu, Colin
[PRESENT POSITIONS] Mathematical Statistician, Office of Biostatistics Research, Division of Cardiovascular Sciences, National Heart Lung and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, Maryland (2002–present).
- Part-Time Professor, Department of Statistics, The George Washington University, Washington D.C. (2012–present).
- Adjunct Professor, Department of Biostatistics, Bioinformatics, and Biomathematics, Lombardi Comprehensive Cancer Center, Georgetown University School of Medicine, Washington D.C. (2013–present).
[FORMER POSITIONS] (1) 1/2010–5/2011, Guest Lecturer, Department of Mathematics, University of Maryland, College Park, Maryland. (2) 7/1998–1/2002, Associate Professor, Department of Mathematical Sciences, G.W.C. Whiting School of Engineering, The Johns Hopkins University, Baltimore, Maryland. (3) 7/1996–7/2002, Adjunct Associate Professor, Department of Biostatistics, School of Hygiene and Public Health, The Johns Hopkins University, Baltimore, Maryland. (4) 6/1997–1/2002, Guest Researcher, Biometry and Mathematical Statistics Branch, Division of Epidemiology, Statistics and Prevention Research, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland. (5) 9/1990–6/1991, Visiting Assistant Professor, Department of Statistics, The University of Michigan, Ann Arbor, Michigan.
[DEGREES] Ph.D. in Statistics, 9/1985–5/1990, Department of Statistics, University of California, Berkeley, CA; B.A. in Mathematics, 4/1982–5/1985, Department of Mathematics, University of California, Los Angeles, CA.
[FIELDS OF MAJOR STATISTICAL ACTIVITIES] Statistical analysis for repeated measurements and longitudinal data, statistical methods for clinical trials and observational studies, estimation and inferences in semiparametric and nonparametric models, biased sampling models, survival analysis, statistical modeling in genetic epidemiology, statistical applications in cardiovascular and blood diseases.
[SELECTED PUBLICATIONS] Book/Monograph: Wu C.O. and Tian X. (2018, “Nonparametric Models for Longitudinal Data: With Implementation in R.” Chapman & Hall/CRC, Monographs on Statistics & Applied Probability #159).
Journal articles (among over 160 publications): (1) Wu, C. O. and Tian, X. (2013). “Nonparametric estimation of conditional distributions and rank-tracking probabilities with time-varying transformation models in longitudinal studies”. Journal of the American Statistical Association, 108(503):971–82. (2) Wu C. O., Kwak M. and Zheng G. (2013). “A joint regression analysis for genetic association studies with outcome stratified samples”. Biometrics, 69(2):417–426. (3) Wu C. O., Tian X. and Jiang W. (2011). “A shared-parameter model for the estimation of longitudinal concomitant intervention effects”. Biostatistics, 12(4):737–49. (4)Wu C. O., Tian X. and Bang H. (2008). “A varying-coefficient model for the evaluation of time-varying concomitant intervention effects in longitudinal studies”. Statistics in Medicine, 2008; 27(16):3042–56. (5) Huang J., Wu C. O., and Zhou L. (2004). “Polynomial spline estimation and inference for varying-coefficient models with longitudinal data”. Statistica Sinica, 14, 763–788. (6) Huang J., Wu C. O., and Zhou L. (2002). “Varying-coefficient models and basis function approximations for the analysis of repeated measurements”. Biometrika, 89, 111–128. (7) Chiang C.-T., Rice J. A., and Wu C. O. (2001). “Smoothing splines estimation for varying coefficient models with longitudinal dependent variable”. Journal of the American Statistical Association, 96 605–619. (8) Rice J. A., and Wu C. O. (2001). “Nonparametric mixed effect models for unequally sampled noisy curves”. Biometrics, 57, 253–259. (9) Hoover D. R., Rice J., Wu C. O., and Yang L.-P. (1998). “Nonparametric smoothing estimates of time-varying coefficient models with longitudinal data”. Biometrika, 85, 809–822. (10) Wu C. O. (1995). “Estimating the real parameter in a two-sample proportional odds model”. Annals of Statistics, 23, 376–395.
[ICSA ACTIVITIES]: (1) Secretary, Biometrics Session (1997-2001); (2). Member, Nomination and Election Committee (2004-2005); (3) Member, Applied Statistics Symposium Committee (1996, 1999, 2005, 2009); (4) Member, Biometrics Section (2004).
[PROFESSIONAL COMMITTEES]: (1) ASA: (a) Member, Committee on International Relations in Statistics (2011-2013); (b) Chairman, Student Paper Award Committee, ASA Section on Nonparametric Statistics (2014-2015). (2) Department of Veterans Affairs (VA): Member (4/2011–Present), Data Monitoring Committee. (3) Association for the Advancement of Medical Instrumentation (AAMI, US): Member (7/2009–Present, independent statistical expert), Sphygmomanometer Committee.
[HONORS AND AWARDS]: Fellow of the American Statistical Association (2012); Elected Member of the International Statistical Institute (2008); National Institutes of Health Director’s Award (2015), Eltrombopag Clinical Research Team.
[STATEMENT] I am grateful to be nominated by the ICSA Nomination and Election Committee as a candidate for the next ICSA president. Benefited by the relentless efforts of all its members and volunteers, ICSA has grown from a relatively small organization in the late 1980’s to a highly reputable statistical society today with over 1000 active members, excellent annual conferences, and two high quality scientific journals: Statistica Sinica and Statistics in Biosciences. The strong leadership and guidance provided by all its past Presidents, Boards of Directors and members of various committees have greatly enhanced the reputation of ICSA as one of the leading statistical associations in the world.
My experience with ICSA: My first participation of ICSA activities was twenty three years ago, when I joined the Program Committee to help organizing the ICSA 1996 Applied Statistics Symposium at Baltimore, Maryland. Since then, I have served on the Biometrics Session, Nomination and Election Committee and the Program Committees of four Applied Statistics Symposiums. I have seen the number of participants in the ICSA Applied Statistics Symposiums grown from barely 200 in the 1990’s to about 600 today, and the ICSA International Conferences have become one of the most prestigious platforms in the world for statistical researchers and practitioners to exchange novel ideas and research results.
Why I accept the challenge of running for ICSA President: The professional activities of ICSA and its interactions with other statistical societies, such as ASA and IMS, have provided many valuable opportunities for collaboration, training and continuing education. As a result, many young ICSA members have become leading researchers in various fields of statistics. My own professional career as a statistical researcher has also been benefited immensely from the activities of ICSA, which include the opportunities for organizing and presenting in ICSA conferences, publishing in ICSA journals and, most important of all, meeting and collaborating with many talented ICSA members. I feel very fortunate to have ICSA as my professional home since the early years of my career, and am thankful for all the help I received from the friends I met at numerous events organized by ICSA. As a permanent member of ICSA, I would very much like to see ICSA to expand and flourish in the future, so that it can further benefit the next generation of statisticians. This task requires time, efforts and dedicated service from its devoted members. To me, it is an honor to have a chance to serve as its President, which would give me an opportunity to further improve the services of ICSA as a leading statistical hub in the world.
Plans and objectives if I am elected: I am committed to the ICSA mission, and will continue all the excellent activities, such as collaborating with other international statistical societies and reaching out to young statisticians, which have been set in motion by the past ICSA Presidents and Boards of Directors. In addition, I would like to strengthen the activities of ICSA in the following areas:
(1) Facing with the new challenges of the “Real World Data/Real World Evidence” (RWD/RWE) era, I would like to promote collaborations with profession societies outside the traditional areas of statistics, and expand the ICSA membership to professionals working on areas interfacing with statistics, such as epidemiology, information technology, system biology, bioinformatics, and other areas of data science. The ICSA conferences and journals can provide some natural platforms for collaborations between statisticians and researchers in these new frontiers of science.
(2) I would like to promote further collaborations among statisticians in academia, industry and government. Although there are lots of collaborative activities among ICSA members, many of the available resources are still under-utilized. For example, the National Institutes of Health (NIH) has many publicly available clinical and genetic datasets, which can be used for statistical collaboration with epidemiologists and geneticists. The ICSA conferences and journals can serve as natural platforms for publicizing the results of such collaborations.
(3) I would like to expand the global reach of ICSA, particularly strengthening the position of ICSA as the leading statistical society in Asia. This would include, for example, promote the membership drive and further improve the visibility of ICSA organized conferences in China.
(4) Realizing that one of the functions of ICSA is to promote its members, ICSA, given its excellent reputation, can play a more active role for potential employers to recruit both young and established statisticians. This may be particularly useful for overseas potential employers.
I am grateful for having this opportunity, and am ready to face the challenges and take the responsibilities for making ICSA a welcoming professional home for its members.