CDISC Board of Directors

Margaret Keegan

Ms. Keegan is Chair of the CDISC Board of Directors and currently serves as Chief Operating Officer at PRA Health Sciences. In this role she leads all operational functions. Ms. Keegan is also a member of the PRA Health Sciences Executive Committee.  Prior to joining PRA Health Sciences, Ms. Keegan was President of Clinical Operations for IQVIA where she also held the role of President, Data Sciences.  In addition, Ms. Keegan has served in a variety of senior leadership positions, including Global Head of Data Management, Head of North America Clinical Operations, Global Head of Integrated Processes and Technologies and Global Head of Enterprise Solutions Development.  

Ms. Keegan has over 25 years’ biopharmaceutical industry experience, holding executive roles at large pharmaceutical and CRO companies. She has led statistics, programming, data management, late phase and clinical functions, and has worked in Europe and the United States. Ms. Keegan holds a Bachelor of Science degree in Pure and Applied Mathematics and is a Chartered Statistician.

 

Pam Howard, MS

Pam Howard serves as Chair Elect of the CDISC Board of Directions and is Vice President of Biostatistics and Programming and Medical Writing at ICON. Prior to this role, she held a number of senior positions within ICON, including Vice President,  Data Management, Vice President, Clinical Operations and Global Business Lead for Metrics and Process Improvement Initiatives.  Ms. Howard has always had an interest in standards, and has actively promoted the application of standards, in particular, to promote data-driven decision making, to increase the quality and productivity of clinical projects, and decrease their costs. She recently completed a diploma and certificate in Company Direction from the Institute of Directors, Ireland. Ms. Howard received her MS in Biostatistics from the University of Reading, UK, an MS in Biotechnology from University College Galway, Ireland and a BS in Industrial Chemistry from the University of Limerick, Ireland.

 

Jonathan Zung, Ph.D.

Dr. Zung is a seasoned pharmaceutical industry executive with over 25 years’ development experience. He is Past Chair of the CDISC Board of Directors and currently serves as Chief Development Officer at Evelo Biosciences. Prior to Evelo, he was president of Sponsor and CRO programs at WCG. Dr. Zung also served as Group President, Clinical Development & Commercialization Services for Covance, Vice President and Head of Global Clinical Sciences and Operations at UCB and Vice President and Head of Global Development Operations at Bristol-Myers Squibb. Dr. Zung currently serves on the Advisory Board for Saama Technologies. He received his doctorate in analytical chemistry from Emory University.

 

Wenjun Bao, Ph.D.

Dr. Wenjun Bao is a Chief Scientist and Sr. R&D Manager for JMP Life Sciences of SAS Institute Inc. She has rich experiences in clinical, biochemistry, molecular biology and bioinformatics research. She has been a research grant review committee member for the NIH since 2005 and research advisor for scientists in universities and government agencies. Dr. Bao is an adjunct professor at Fudan University in Shanghai and a Chinese CDISC Coordinating Committee Member.

 

Chris Decker, MS

Chris Decker is Vice President, Life Sciences and Principal at d-Wise, a technology and process consulting company focused on empowering innovation for a healthier world. Chris provides leadership to large scale enterprise solutions for life science companies, leading teams of domain and technical experts, delivering clinical systems integration and data standards solutions, and supporting the adoption of technology and process optimization to improve the clinical trial lifecycle. He served as the co-lead of the CDISC Integration Pilot Project, as a member of the PHUSE Board of Directors for four years and has volunteered across the industry throughout his career. Chris also co-led the creation and implementation of the FDA PHUSE Computational Sciences Collaboration where he now serves on the Steering Committee. Prior to d-Wise, he spent many years consulting within and for pharmaceutical sponsors across a range of therapeutic areas, leading data integration and process improvement initiatives. Chris received his BS in Statistics from Virginia Tech University and his MS in Statistics from NC State University.

 

David Hardison, Ph.D.

Dr. Hardison has spent over three decades striving to make a difference for patients by helping organizations develop capabilities that leverage data, digital and science to improve diagnoses, treatments, and care delivery throughout the global healthcare ecosystem.

He recently retired from ConvergeHEALTH by Deloitte where he served as Vice President of Health Sciences and focused on helping life science organizations optimize evidence planning, generation and management throughout the product life cycle. This includes leveraging his extensive global experience in the healthcare ecosystem to develop strategies, tactics, and technologies for gaining optimal insights across proprietary research data, public data and Real World Data that help companies embrace Precision Medicine and Value-based Reimbursement.

He has served as a strategic advisor to healthcare executive teams, physician organizations and boards of trustees on continuous quality improvement and served the dual role of Vice President of Continuous Improvement and CIO of a health system. Dr. Hardison has also served in several industry leadership positions.

 

Pandu Kulkarni, Ph.D.

Dr. Pandu Kulkarni is the Chief Analytics Officer R&D and Vice President of Statistics, Data, and Analytics at Eli Lilly and Co. Dr. Kulkarni leads a large division of people composed of statisticians from discovery to commercialization, advanced analytics, data management, data standards and technology. He joined Eli Lilly in 2000 and has held numerous leadership positions, including technical and management positions within, and outside of, Statistics.

Before joining Lilly, Dr. Kulkarni was a tenured professor at the University of South Alabama. He has worked with NASA, Air Force, and given numerous invited presentations and workshops across the globe to provide training and continuing medical education. He has published over 50 articles in statistics and medical areas in peer-reviewed journals.

He earned his Ph.D. in Statistics at LaTrobe University, Australia.

 

Zhengqing Li, Ph.D.

Dr. Zhengqing Li is Global Vice President and Head of MSD China R&D at Merck.  He leads a development team whose primary mission is to bring innovative medicines and vaccines effectively and efficiently to meet the unmet medical needs of Chinese patients. Dr. Li also plays a leadership role in building Merck’s global capabilities in China in the area of quantitative sciences and in establishing external collaborations with research institutes, professional societies and industry partners.  Under his leadership, the MSD China R&D Center has grown dramatically with more than 600 scientists.

Previously, Dr. Li held leadership roles with Bristol-Myers Squibb and worked with increasing responsibility in drug development at Pfizer and Procter & Gamble Pharmaceuticals. He has authored and co-authored more than 40 scientific and clinical trial methodology papers and abstracts. Additionally, Dr. Li has played a leadership role in the development and approval of more than 20 drugs or new indications in China and United States.

Dr. Li received his undergraduate education at University of Science and Technology of China and his PhD in Biostatistics from University of Wisconsin-Madison. Upon completion of his PhD, he took a faculty position in the School of Public Health at State University of New York at Albany.

 

Hiroshi Masumoto, Ph.D.

Hiroshi Masumoto is Vice President of Data Intelligence at Daiichi Sankyo. Hiroshi leads the function, supervising clinical epidemiology, biostatistics, data management, and clinical data system and standards. His focus is to contribute to informed decision-making and value proposition through data-driven sciences. Hiroshi has broad experience and expertise in the pharmaceutical industry, including non-clinical research, global project management, corporate strategy and brand strategy. He received his Ph.D. in Bio-Organic and Medicinal Chemistry and BS in Pharmaceutical Chemistry from the University of Tokyo.

 

Mihoko Okada, Ph.D.

Dr. Mihoko Okada became President of the Institute of Health Data Infrastructure for All in May 2018. Prior to this role, she was a Professor of Health Informatics at Kawasaki University of Medical Welfare for 20 years, after serving as an Associate Professor of Statistics at Niigata University. Dr. Okada was the President of the Japan Association for Medical Informatics from 2013 to 2016 and has been with the ICH M2 EWG (Electronic Transfer of Regulatory Information) since 1998 and is currently an M2 Co-Rapporteur.

 

Erik Pulkstenis, Ph.D.

Dr. Erik Pulkstenis is Vice President and Global Head of Data and Statistical Sciences in support of clinical development strategy, data science, statistical analysis and reporting/analytics at AbbVie. Previously, Dr. Pulkstenis headed Clinical Biostatistics & Data Management at Medimmune, led the Biostatistics Department at Human Genome Sciences, and served at C.L. McIntosh & Associates consulting with medical device manufacturers with respect to study design, regulatory strategy, and FDA Advisory Committee preparation. From 2013 to 2019 he served on the American Statistical Association Biopharmaceutical Section Executive Committee and currently serves on the ICH E20 Adaptive Design Expert Working Group. Dr. Pulkstenis received an M.S. and Ph.D. in statistics from the Pennsylvania State University.

 

Christina Reith, BSc, MBChB, PhD, FRCP, FFPM

Dr. Christina Reith is a Senior Clinical Research Fellow at the University of Oxford’s Nuffield Department of Population Health (NDPH), where she primarily works on large-scale clinical trials and meta-analyses in relation to cardiovascular disease. She is also involved in teaching on the NDPH Global Health Sciences MSc, is a UK General Medical Council Educational Supervisor for Pharmaceutical Medicine specialty training, and acts as a College Advisor for students at the University of Oxford's Green Templeton College.

Christina studied at The University of Glasgow, gaining a first class honours degree in medical biochemistry and subsequently her medical degree, when she was jointly awarded the Brunton Medal for the most distinguished graduate in medicine.

 

Steve Rosenberg

Steve Rosenberg is Senior Vice President and General Manager of Oracle Health Sciences. He has over 30 years’ experience in the life sciences and healthcare arenas, leading development, services, support, and consulting. Mr. Rosenberg possesses a unique ability to address and influence the changing life sciences landscape, using his deep domain understanding, customer relationships, and technology vision.  He served as the visionary and lead evangelist for the integrated clinical technology suite introduced by Phase Forward. As senior vice president of Software and Services at Phase Forward, Mr. Rosenberg was an integral member of the senior management team and championed the integrated technology approach.