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DIA/FDA Statistics Forum

The DIA/FDA Statistics Forum fosters open discussion of timely topics of mutual theoretical and practical interest to biostatisticians and clinical trialists.


Speakers

  • Frank  Bretz, PhD

    Frank Bretz, PhD

    • Global Head of Statistical Methodology
    • Novartis Pharma AG, Switzerland

    Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs.

  • Pandurang M Kulkarni, PhD

    Pandurang M Kulkarni, PhD

    • Vice President, Global Biometrics & Advanced Analytics
    • Eli Lilly and Company, United States

    He obtained his PhD in Statistics at the LaTrobe University, Melbourne, Australia. He taught and did research in statistics at the University of South Alabama for10 years attained full professorship. He received grants from the Air Force for the development of techniques to evaluate and study the effects of environmental contaminants. He also received grants from NASA to study the effects of microgravity to see the effectiveness of exercise countermeasures in minimizing the effects of microgravity on astronauts. He joined Eli Lilly in 2000 and has held leadership positions within and outside of Statistics. He has published more than 50 articles in statistics and medical areas in peer reviewed journals.

  • Jeff  Maca, PhD

    Jeff Maca, PhD

    • Senior Director, Biostatistics; Advisory Services Analytics
    • Quintiles, United States

    Jeff Maca is a Principal Scientific Advisor in Advisory Services Analytics at Quintiles, with over 19 years of experience in the pharmaceutical industry. Prior to Quintiles, he worked with Novartis Pharmaceuticals as a project statistician, prior to assuming the role of a statistical consultant within the statistical methodology group. He has been active in statistical methodology research and has numerous publications on pharmaceutical statistics, including adaptive designs, multiplicity, and interim decision making. Along with research and consulting work, Jeff also participates in the DIA Adaptive Designs SWG. Jeff received his PhD in Statistics from Texas A&M University.

  • Cristiana  Mayer, PhD

    Cristiana Mayer, PhD

    • Scientific Director, Statistical Modeling and Methodology, SDS
    • Janssen Research and Development LLC, United States

    Cristiana is Scientific Director at Janssen R&D, Johnson & Johnson. She joined the Statistical Modeling & Methodology group in 2013, after a 15-year tenure in the Biostatistics Department as Statistical Leader in many TA’s including hematology, neurology, psychiatry, immunology and metabolism. Cristiana is currently the Head of the Adaptive Clinical Trials Center of Excellence. Cristiana’s recent research interests include adaptive designs, Bayesian approaches to non-inferiority and one-arm trials, recurrent event models and analysis of suicidal ideation and behaviors. She has a Ph.D. in Statistics from the University of Trento, Italy. She currently co-leads the DIA adaptive design working group subteam on simulation report best practices.

  • Dionne  Price, PhD

    Dionne Price, PhD

    • Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
    • FDA, United States

    Dionne Price is the Director of the Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA). In this role, Dr. Price provides leadership to statisticians involved in the development and application of methodology used in the regulation of anti-infective, anti-viral, ophthalmology, and transplant drug products. Dr. Price holds a MS in Biostatistics from the University of North Carolina at Chapel Hill and a PhD in Biostatistics from Emory University. Dr. Price is an active member of the International Biometric Society and the American Statistical Association.

  • Jerald S. Schindler, DrPH

    Jerald S. Schindler, DrPH

    • VP, Data Science & Statistics, Alnylam and Adjunct Professor,
    • Harvard Chan School of Public Health, United States

    Dr. Schindler is VP, Biostatistics & Research Decision Sci. & leads the Late Development Biostat. groups in Merck Research Labs. He is involved in optimizing the development process of new drugs & biologics including use of innovative adaptive CTs & efficient integrated clinical info systems.

  • William  Wang, PhD

    William Wang, PhD

    • Executive Director, Clinical Safety Statistics, BARDS
    • Merck Research Laboratories, United States

    Bill has over 20 years of experience in the pharmaceutical industry, with expertise and research publications in statistical design, analysis, clinical data management and relevant technology enablement. During his 15-year tenure at Merck, he supported regulatory filings in multiple therapeutic areas and led the establishment of the BARDS Asia Pacific operation in China (2007-2014). Since 2010, he has served on the DIA China Regional Advisory Board and DIA’s Global Community Leadership Council. He was a recipient of the DIA global outstanding service award in 2012. Currently chairs anASA safety working group, and serves as a deputy topics leader for the ICH E17 working group on Multi-Regional Clinical Trial (MRCT).

  • Amy  Xia, PhD

    Amy Xia, PhD

    • Executive Director, Biostatistics
    • Amgen, Inc., United States

    Amy Xia is Executive Director, Biostatistics at Amgen. She has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies in the past 20 years. Her research interests include Bayesian and adaptive design, safety biostatistics, meta-analysis and innovative approaches for pediatrics/rare diseases drug development. Amy is an ASA Fellow. She is the Editor for the Biopharmaceutical Report in 2016-2017. She also is a member of the DIA Bayesian Scientific Working Group. Amy received her Ph.D. in Biostatistics from the University of Minnesota, and B.Med. (M.D. equivalent) from Peking University, China.

  • Thomas E. Gwise, PhD

    Thomas E. Gwise, PhD

    • Deputy Division Director, Division of Biometrics V, CDER
    • FDA, United States

    Thomas Gwise is Deputy Director of the Division of Biometrics 5, the statistical group at FDA's Center for Drug Evaluation and Research who review oncology drug applications. Before moving to CDER, Dr. Gwise was a team leader in the Diagnostic Devices Branch in FDA's Center for Devices and Radiological Health.

  • Rima  Izem, PhD

    Rima Izem, PhD

    • Lead Mathematical Statistician, Office of Translational Science, CDER
    • FDA, United States

    Rima Izem currently supervises a team of statisticians reviewing sponsor studies for post-market safety and consumer behavior studies for OTC drugs. Her team is actively involved in multiple FDA led safety studies using FDA's Sentinel System or Center for Medicare and Medicaid Services as well as social science studies assessing direct to consumer drug advertising. At FDA, she has worked in multiple therapeutic areas including cardiovascular, anti-infective, anti-viral, reproductive health, analgesia and addiction. Prior to joining the FDA in June 2008, she was an Assistant Professor at the Statistics Department at Harvard University for four years. She earned a PhD in Statistics from the University of North Carolina at Chapel Hill in 2004.

  • Laura Lee  Johnson, PhD

    Laura Lee Johnson, PhD

    • Associate Director, Office of Biostatistics, DB III, OTS, CDER
    • FDA, United States

    Dr. Laura Lee Johnson is the patient reported outcomes liaison for the Office of Biostatistics at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research. She serves on the FDA-NIH Interagency Clinical Outcome Assessments Working Group and co-directs the NIH Principles and Practice of Clinical Research course. Prior to working at the FDA she spent over a decade at the NIH working on and overseeing clinical research and research support programs. She has been involved with numerous projects developing, validating, and using clinical outcome assessments in both patient care and research.

  • Lisa M. LaVange, PhD

    Lisa M. LaVange, PhD

    • Director, Office of Biostatistics, Office of Translational Sciences, CDER
    • FDA, United States

    Lisa LaVange, PhD, is Director of the Office of Biostatistics in the Center for Drug Evaluation and Research at FDA, where she oversees approximately 215 statisticians and support staff. She is a former faculty member in the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. Prior to that, she spent 10 years in the pharmaceutical industry and 16 years in non-profit research. She is Fellow of the American Statistical Association (ASA), former Board Member and Eastern North American Regional President of the International Biometric Society, and upcoming President-Elect of ASA.

  • Mark S. Levenson, PhD

    Mark S. Levenson, PhD

    • Director, Division of Biometrics VII, Office of Biostatistics, CDER
    • FDA, United States

    Mark Levenson is the Director of the Division of Biometrics 7 in the Office of Biostatistics/Office of Translational Sciences/Center for Drug Evaluation and Research of FDA. At FDA, he has been the primary reviewer or secondary reviewer on many major pre-market and post-market drug safety problems. He has contributed to the methodology of the application of meta-analysis and propensity score analysis to the regulatory setting. As the Director of the biostatistics division in CDER devoted to safety analysis, he contributes to statistical policy in the area of drug safety.

  • Annie  Lin

    Annie Lin

    • Baxter, China

  • Rajeshwari  Sridhara, PhD

    Rajeshwari Sridhara, PhD

    • Director, Division of Biometric V, Office of Biostatistics, OTS, CDER
    • FDA, United States

    Rajeshwari Sridhara, Ph.D. is the Division Director of Division of Biometrics V, Office of Biostatistics which supports Office of Hematology Oncology Products, CDER, FDA. Dr. Sridhara joined the FDA in 1999. She routinely presents the regulatory policies and scientific philosophy of the Office at national and international professional meetings. She has contributed in the understanding and addressing the statistical issues that are unique to the oncology disease area such as evaluation and analysis of time to disease progression. She has extensively published in refereed journals and presented at national and international conferences.

  • Stephen E. Wilson, DrPH

    Stephen E. Wilson, DrPH

    • Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
    • FDA, United States

    Dr. Wilson has worked as a Statistical Reviewer and Supervisory Mathematical Statistician in FDA’s Center for Drug Evaluation and Research (CDER) for more than 29 years. He is currently the Director of the Division of Biometrics III. He received his doctorate in Biostatistics from the University of North Carolina, Chapel Hill, in 1984

  • Mouna  Akacha, PhD

    Mouna Akacha, PhD

    • Statistical Methodologist
    • Novartis Pharma AG, Switzerland

    Mouna Akacha is a consultant in the Statistical Methods & Consulting Group of Novartis Pharma AG, based in Basel, Switzerland. In this role she provides internal advice for clinical projects across all development phases and therapeutic areas. Her role also includes training of internal statisticians and collaborations with external statistical centers and researchers. Mouna has a wide range of research interests including topics on missing data, estimands, longitudinal data and recurrent event data. Before joining Novartis, Mouna studied mathematics at the University of Oldenburg in Germany and holds a PhD in statistics from the University of Warwick in the UK.

  • Keaven  Anderson, PhD

    Keaven Anderson, PhD

    • Distinguished Scientist, Late Development
    • Merck Research Laboratories, United States

    A Fellow of the ASA and a Distinguished Scientist focusing primarily on statistical support for late-stage oncology drug development at Merck Research Laboratories since 2003. Areas of research have included risk prediction for cardiovascular disease and adaptive design with a focus on group sequential design. A current interest is in non-proportional hazards models and multiplicity in group sequential trials due to their relevance for immuno-oncology development. Keaven has previously worked in many drug, biologic and vaccine development areas at Merck and at Centocor/J&J. He is the primary author and maintainer of the open source R package gsDesign and its associated web interface for designing group sequential trials.

  • Jesse Aaron Berlin, DrSc

    Jesse Aaron Berlin, DrSc

    • Senior Vice President, Epidemiology
    • Johnson & Johnson, United States

    Dr. Berlin received his doctorate in biostatistics from the Harvard School of Public Health in 1988. After 15 years on faculty at the University of Pennsylvania, Jesse left Penn to join Janssen R&D in Biostatistics. He now serves as Vice President of Epidemiology across all of Johnson & Johnson. He has over 260 peer-reviewed publications. He was elected as a fellow of the American Statistical Association in 2004. In 2013, Dr. Berlin received the Lagakos Distinguished Alumni Award from the Department of Biostatistics at the Harvard School of Public Health.

  • Jesse  Bridgewater

    Jesse Bridgewater

    • Vice President, Data Science
    • Livongo, United States

    Jesse Bridgewater leads data science at Livongo, a digital health company that empowers people with chronic conditions to live better. Jesse is excited to help people live healthier by applying lessons learned leading teams at consumer internet companies including Twitter, Ebay, and Microsoft. His academic training is in Physics and Electrical Engineering and did his PhD at UCLA.

  • Joan  Buenconsejo, PhD, MPH

    Joan Buenconsejo, PhD, MPH

    • Statistics Team Leader, Inflammation, Neuroscience & Respiratory TA, B&I Science
    • AstraZeneca, United States

    Dr. Joan Buenconsejo is a Director and Biometrics Team Leader supporting the oncology therapeutic area within the Biometrics and Information Sciences at AstraZeneca. Prior to joining AZ, she was a statistics team leader supporting the Division of Pulmonary, Allergy and Respiratory Products at CDER/FDA for 4 years and a statistical reviewer for 6 years. She is the chair of DIA Statistics Community, North America. Dr. Buenconsejo received her master’s degree in Mathematical Statistics from University of California, Irvine, and master’s in Public Health and a doctorate degree in Biostatistics from Yale University.

  • Gregory  Daniel, PhD, MPH, RPh

    Gregory Daniel, PhD, MPH, RPh

    • Deputy Director and Clincial Professor
    • Duke-Margolis Center For Health Policy, United States

    Dr. Gregory Daniel is Deputy Director and Clinical Professor in the Duke-Robert J. Margolis Center for Health Policy. Dr. Daniel directs the DC-based office and leads its pharmaceutical and medical device policy portfolio aimed at developing strategies for improving development and access to innovative pharmaceutical and medical device technologies, postmarket evidence development, regulatory science, and value-based payment reform.

  • John  Farley, MD

    John Farley, MD

    • Deputy Director, Office of Antimicrobial Products
    • FDA, United States

  • Renee  Iacona, PhD

    Renee Iacona, PhD

    • TA Biometrics Head, Oncology & Immuno-Oncology
    • AstraZeneca Pharmaceuticals LP, United States

    Renee Iacona leads the Biometrics & Information Sciences department for the late stage Oncology & Immuno-Oncology portfolio at AstraZeneca, where she is in her 16th year. Currently, she is coleading a cross-pharma collaboration on issues related to Non-Proportional Hazards in Oncology drug development and a member of the RECIST working group that looked at the iRECIST guidelines. Renee was also previously involved in the PhRMA Working Group that looked at sensitivity analysis methods related to Progression-Free Survival. She received her PhD and MPH from Vanderbilt University.

  • Frank W. Rockhold, PhD, MSc

    Frank W. Rockhold, PhD, MSc

    • Professor of Biostatistics
    • Duke Clinical Research Institute, Duke University Medical Center, United States

    Over a 40+ year career, Frank has had diverse leadership experience inside & outside GSK in clinical trials, data standards, benefit/risk, clinical research, epidemiology, cardiovascular development, & most recently pharmacovigilance. He has served on the board of directors for CDISC, & is a member of the PCORI Advisory Panel on Clinical Trials. He has +175 publications/presentations in major scientific journals. He is a Fellow of the ASA & the Society for Clinical Trials.

  • John  Scott, PhD

    John Scott, PhD

    • Acting Director, Division of Biostatistics, OBE, CBER
    • FDA, United States

    John Scott is Deputy Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and missing data. He holds a Ph.D. in Biostatistics from the University of Pittsburgh and an M.A. in Mathematics from Washington University in St. Louis, and is an associate editor of the journal, Pharmaceutical Statistics.

  • Judy Anne Staffa, PhD, RPh

    Judy Anne Staffa, PhD, RPh

    • Director, Division of Epidemiology II, OPE, OSE , CDER
    • FDA , United States

    Judy Staffa, Ph.D., R.Ph., is the Associate Director for Public Health Initiatives at FDA, Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), where she is responsible for setting strategic direction for complex, multidisciplinary reviews related to opioid abuse – from a planning, scientific, and policy point of view. Judy is a pharmacist who received her B.S. in pharmacy from the University of Connecticut. She practiced community pharmacy prior to receiving her M.S. in Behavioral Sciences from the Harvard School of Public Health, and her Ph.D. in Epidemiology from the Johns Hopkins Bloomberg School of Public Health.

  • Janet  Woodcock, MD

    Janet Woodcock, MD

    • Director, Center for Drug Evaluation and Research
    • FDA, United States

    In 2015, Dr. Woodcock also operated in the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ). Dr. Woodcock joined CDER in 1994. From 2005 - 2008, she served in FDA’s Commissioner’s office, holding several positions, as Deputy Commissioner, Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. Her responsibilities encompassed oversight of various scientific and medical regulatory operations. Before CDER, Dr. Woodcock served as Director, Office of Therapeutics Research and Review, and Acting Deputy Director in FDA’s Center for Biologics Evaluation and Research. Dr. Woodcock received her MD from Northwestern Medical School. She joined FDA in 1986.

  • Kunthel  By

    Kunthel By

    • Biostatistician
    • FDA, United States

    Kunthel By is a biostatistician at the Center for Drug Evaluation and Research at FDA for the past 5 years. He works primarily in the post-market side of the regulatory process, with emphasis on the design and analysis of observational studies that assess safety outcomes after drug exposures. Prior to joining FDA, he was a graduate student at UNC Chapel Hill and a technical writer at SAS, composing documentations for various SAS products.

  • Elizabeth  Delong, PhD

    Elizabeth Delong, PhD

    • Chair, Biostatistics and Bioinformatics
    • Duke University, United States

    Dr. DeLong interests are in the field of comparative effectiveness in the area of quality-of-care, with emphasis on risk adjustment methodology, assessment of risk prediction models, and provider profiling. With 20+ years of biostatistics, clinical research, and bioinformatics experience, her responsibilities have included administrative and data analytic functions, as well as statistical methods development. She currently leads the Biostatistics and Study Design Core of the NIH Health Care Systems Research Collaboratory.

  • Vladimir  Dragalin, PhD

    Vladimir Dragalin, PhD

    • VP, Head of QS Consulting, Quantitative Science
    • Janssen R&D, at Johnson & Johnson, United States

    Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is leading the Adaptive Clinical Trial Center of Excellence. He is a well-known adaptive design expert with 25 years of experience in developing the statistical methodology of adaptive designs and with over 15 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. He has more than 75 publications in peer reviewed journals and books.

  • Shyla  Jagannatha, PhD

    Shyla Jagannatha, PhD

    • Scientific Director
    • Janssen Pharmaceuticals Inc., United States

  • Kenneth I. Kaitin, PhD

    Kenneth I. Kaitin, PhD

    • Professor of Medicine; Director Tufts Center for the Study of Drug Development
    • Tufts University School of Medicine, United States

    Kenneth Kaitin is Professor and Director of the Tufts Center for the Study of Drug Development at Tufts University School of Medicine. He’s also Advisory Professor at Shanghai Medical College, Fudan University. Dr. Kaitin writes and speaks regularly on drug development issues, and has provided testimony before the U.S. Congress. A former President of the Drug Information Association, Dr. Kaitin is Editor-in-Chief of Expert Review of Clinical Pharmacology, and consultant to the U.S. Department of Defense on bioterror countermeasures. Dr. Kaitin received his PhD in pharmacology from the University of Rochester.

  • Sumithra J. Mandrekar, PhD

    Sumithra J. Mandrekar, PhD

    • Biostatistician
    • Mayo Clinic, United States

    Dr. Mandrekar is a Professor of Biostatistics and Oncology as well the Group Statistician for the Alliance for Clinical Trials in Oncology and Section Head for Cancer Center Statistics at Mayo Clinic. Her primary areas are lung cancer and leukemia. She is the faculty statistician for the national adjuvant lung cancer trial, ALCHEMIST, which is part of the NCI precision medicine initiative. Her research interests include adaptive dose-finding trial designs for Phase I trials, designs for predictive biomarker validation, and general clinical trial methodology related to identification of alternative Phase II cancer clinical trial endpoints. Dr. Mandrekar has co-authored140+ original papers, several book chapters and editorials

  • Peter A. Milligan, PhD

    Peter A. Milligan, PhD

    • Head of Pharmacometrics
    • Pfizer Global Research & Development, United Kingdom

  • Theresa M. Mullin, PhD

    Theresa M. Mullin, PhD

    • Director, Office of Strategic Programs, CDER
    • FDA, United States

    Dr. Theresa Mullin plays a lead role in a number of CDER’s strategic initiatives including the human drugs international program, drug user fee negotiation and implementation, regulatory informatics, and major program evaluations and other initiatives. She is currently serving as FDA’s lead negotiator for the 2017 reauthorizations of the Prescription Drug User Fee Act and the Biosimilar User Fee Act. She leads the FDA Patient Focused Drug Development Initiative and heads the FDA delegation to the International Council on Harmonization, the primary venue for international harmonization of drug regulatory standards.

  • Sudip  Parikh, PhD

    Sudip Parikh, PhD

    • Senior Vice President and Managing Director, DIA Americas
    • DIA , United States

  • Michael A. Proschan, PhD

    Michael A. Proschan, PhD

    • Biostatistics Research
    • National Institute of Allergy & Infectious Disease, United States

    Michael Proschan has been a Mathematical Statistician in the Biostatistics Research Branch at the National Institute of Allergy and Infectious Diseases since January of 2006. Prior to coming to NIAID, he spent 16 years at the National Heart, Lung, and Blood Institute. He co-authored the books: Statistical Monitoring of Clinical Trials: A Unified Approach, with Gordon Lan and Janet Wittes (Springer, 2006) and Essentials of Probability Theory for Statisticians, (CRC Press, 2016) with Pamela Shaw. Dr. Proschan received his Ph.D. in Statistics from Florida State University in 1989. He became a Fellow of the American Statistical Association in 2005.

  • Mary  Redman, PhD

    Mary Redman, PhD

    • Lead Biostatistician, SWOG Lung Committee/LungMap, Assoc. Member, Clin Research
    • Fred Hutchinson Cancer Research Center, United States

    Mary Redman is an Associate Member in the Clinical Biostatistics Group within the Clinical Research Division at the Fred Hutchinson Cancer Research Center. In addition she is the lead statistician for the Lung Cancer Committee in SWOG and the lead statistician of the Lung-MAP trial.

  • Marie  Schiller

    Marie Schiller

    • Vice President, Drug Delivery/Device R&D Innovation
    • Lilly and Company, United States

    In her role as Vice President, Connected Care and Site Head, Cambridge Innovation Center, Marie oversees the R&D efforts for Lilly’s connected product systems portfolio and leads a cross-disciplinary research team focused on creating the future generation of product solutions for Lilly’s therapeutic portfolio. Prior to joining Lilly, Marie held a number of roles, including Managing Director at Health Advances and Co-Founder of the T1D Exchange, leading the development efforts of complex hardware and software product solutions for people with chronic diseases. Marie earned her Bachelor of Arts in chemistry from the University of Vermont.

  • Brian D. Bradbury, MA

    Brian D. Bradbury, MA

    • Executive Director & Head, Data and Analytics, Center for Observational Research
    • Amgen, Inc., United States

    Dr Bradbury's team has the responsibility of developing and maintaining Amgen’s RWD platform, conducting epidemiologic research on the incidence and prevalence of target clinical indications, supporting RCT design, and conducting post-marketing comparative effectiveness and safety research. Brian is also an Adjunct Associate Professor of Epidemiology at the UCLA School of Public Health. Brian received his DSc in Epidemiology from Boston University in 2004. He has authored/co-authored 70+ peer-reviewed publications in the areas of pharmacoepidemiology, cancer and kidney disease epidemiology and methods for controlling confounding-by-indication in drug safety studies.

  • Margaret  Gamalo, PhD

    Margaret Gamalo, PhD

    • Statistical Scientist
    • Eli Lilly and Company, United States

  • Frank E Harrell, PhD

    Frank E Harrell, PhD

    • Expert Statistical Consultant
    • FDA, United States

    Professor and Chairman, Dept. of Biostatistics, Vanderbilt University School of Medicine and Expert Statistical Adviser, Office of Biostatistics, FDA CDER

  • Kun  He, PhD

    Kun He, PhD

    • Mathematical Statistician
    • FDA, United States

    Kun He is a mathematical statistician in the Division of Biometrics V, Office of Biostatistics, CDER, FDA. He received a Ph.D in statistics from Cornell University, and previously served on the faculties of the University of Minnesota and the University of Kansas. Since joining FDA in 1999, he has provided statistical support for the clinical division of neurology, psychiatry, and hematology and oncology. Currently, he is supporting the Division of Oncology Products 2, Office of Hematology and Oncology Products.

  • Min  Min, PhD

    Min Min, PhD

    • Mathematical Statistician, OB, OTS, CDER
    • FDA, United States

  • Scott  Novak, PhD

    Scott Novak, PhD

    • Director of Prescription Drug Research
    • Battelle Memorial Institute , United States

    Scott Novak, PhD is the Managing Director of the Prescription Opioid Treatment and Research Unit at Battelle Memorial Institute. He is active in studies investigating the epidemiology of new synthetic/designer drugs of abuse in the United States and internationally as well as the use and abuse of marijuana and prescription opioids. Dr. Novak's expertise is in novel statistical and methodological approaches to the analysis of epidemiological and clinical data, including extensions of the generalized linear mixed model (e.g., HLM) to classification, measurement, and diagnosis of disease. He is the principal investigator on several NIH grants and commercial projects, and has authored more than 100 papers and presentations.

  • Kert  Viele, PhD

    Kert Viele, PhD

    • Director and Senior Statistical Scientist
    • Berry Consultants, United States

    Kert Viele is a Director and Senior Statistical Scientist with Berry Consultants, specializing in the design of Bayesian and adaptive clinical trials. He joined Berry Consultants in 2010 after serving as a faculty member in Statistics at the University of Kentucky. He is a former editor of the journal Bayesian Analysis and an author of the software package FACTS used by many academic, government, and industrial entities to simulate complex adaptive trials.

  • Zhenzhen  Xu

    Zhenzhen Xu

    • Visiting Scientist
    • FDA, United States

    Zhenzhen Xu attended Harvard University, graduating in 2004 with a M.A., and went on to earn a Ph.D. from Michigan Biostatistics in 2010. She currently works at FDA as a mathematical statistician in the center for Biologics evaluation and research. Dr. Xu’s research develops novel methods for the design and analysis of clinical trials, particularly cancer immunotherapy trials and cluster randomized trials.

  • Telba  Irony, PhD

    Telba Irony, PhD

    • Deputy Director, Office of Biostatistics and Epidemiology, CBER
    • FDA, United States

    Telba Irony is Deputy Director of the Office of Biostatistics and Epidemiology at CBER, FDA. She joined FDA to implement Bayesian statistics in medical device clinical trials and led the Decision Analysis initiative at CDRH, involving Bayesian statistics, benefit-risk determinations and patient preference studies. Telba received the 2014 FDA Excellence in Analytical Science Award for spearheading innovative regulatory science studies culminating in the release of novel guidance documents, supporting complex policy decision making and changing the submission review paradigm. She has a PhD from Berkeley and is a fellow of ASA and an elected member of ISI.

  • Lian  Ma, PhD

    Lian Ma, PhD

    • Pharmacometrics Reviewer, CDER
    • FDA, United States

  • David  Martin, MD, MPH

    David Martin, MD, MPH

    • Liaison to the Reagan-Udall Foundation IMEDS Program, OMP, CDER
    • FDA, United States

    David Martin is involved in opening Sentinel resources to the public, developing real world evidence policy, and engaging patients in evidence generation. He is the principal investigator for the first effort to capture patient-provided data through a mobile device application, store it in a secure repository, and link it to electronic data in Sentinel and PCORnet. Dr. Martin previously practiced medicine in the USAF, and he received his M.D. and M.P.H. from the Johns Hopkins University.

  • Zhong  Gao, PhD

    Zhong Gao, PhD

    • Mathematical Statistician
    • FDA, United States

  • Eric  Gibson, PhD

    Eric Gibson, PhD

    • VP, Global Head Biostatistical Sciences and Pharmacometrics
    • Novartis Pharmaceuticals Corporation, United States

    Eric Gibson is currently the Head of Biostatistics and Pharmacometrics for Novartis Global Drug Development. Eric has his Ph.D. in Statistics from Kansas State University and has worked for 20 years leading teams of quantitative scientists to influence design and decision making within clinical drug development.

  • Sue-Jane  Wang, PhD, MA, MS

    Sue-Jane Wang, PhD, MA, MS

    • Assoc. Dir., Adaptive Design & Pharmacogenomics, OB, OTS, CDER
    • FDA, United States

    Dr. Sue-Jane Wang is Office Associate Director and Biostatistics Lead/Coordinator of FDA/CDER Biomarker Qualification Program from Office of Biostatistics, CDER, FDA. She is an ASA Fellow. Her well-recognized professional expertise includes pharmacogenomics, adaptive design and biomarker associated clinical trial designs and analysis methods with more than 100 peer-reviewed publications in clinical trials, bioinformatics, and specific clinical journals related to genomic/genetic and common diseases. Dr. Wang has served as an Editor-in-Chief for Pharmaceutical Statistics. She has also served as a Guest Editor-in-Chief for, e.g., Biometrical Journal, Journal of Biopharmaceutical Statistics. Dr. Wang is an Associate Editor for a few journals.

  • Changming  Xia, PhD, MA, MS

    Changming Xia, PhD, MA, MS

    • Mathematical Statistician
    • FDA, United States

    Changming (Sherman) Xia is a mathematical statistician at the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He contributes to statistical regulatory activities in the area of drug safety. Prior to joining the FDA, he was a senior research statistician at AbbVie. He holds a PhD in Statistics from University of Rochester.

  • Jimmy  Wong

    Jimmy Wong

    • Statistician
    • FDA, United States