Jeff Abolafia
Jeff Abolafia is currently Director of Product Innovation at Pinnacle 21. Previously Jeff held the position of Chief Strategist of Data Standards and was a member of the faculty in the Department of Biostatistics at the University of North Carolina. Jeff has been involved with public health research and data standards for over thirty years. Jeff co-founded the RTP CDISC User's Group and is a member of the CDISC ADaM and Analysis Results teams and several PHUSE Real World Evidence working groups. His areas of interest include real world evidence, mobile health, data standards, and regulatory submissions.
|
 |
Pradeep Bangalore
Pradeep Bangalore is the Co-founder of Cesta Inc., which provides Software Solutions and IT Consultancy services to the Pharmaceutical, Biotech, and CRO industries. Pradeep’s passion for data analysis and his commitment to providing clients with the best possible service have made him a highly sought-after consultant. He is known for his ability to translate complex data into actionable insights that can help clients improve their business performance. He is also a highly effective communicator, and he is able to explain complex concepts in a clear and concise way. He is a frequent speaker at industry conferences, and he is always eager to share his knowledge and expertise with others.
|
 |
Jim Box
Jim Box is a data scientist with the Life Sciences Industry Consultants at SAS. Prior to that he spent 20 years in the CRO industry primarily as a study statistician. He holds Masters Degrees in Statistics from Duke University and Analytics from North Carolina State University and is a frequent presenter at PharmaSUG and other industry conferences.
|
 |
Dany Guerendo Christian
Dany Guerendo Christian, M.A, is an accomplished Data Analyst (20+ years) and Programmer. She holds a master’s in mathematics from Indiana University and a Graduate Certificate in Applied Statistics from Texas A&M. She is a certified project management professional, PMP®. She programs in SAS, R, and Python. She has extensive leadership experience in clinical data standards (CDISC) for regulatory submission.
|
 |
Priscilla Gathoni
Priscilla Gathoni is an executive leadership coach, facilitator, author, inspirational and motivational speaker, educator, and voice artist. Dr. Gathoni has delivered inspirational and unforgettable talks at global conferences and community events. As a coach, Dr. Gathoni is a charismatic and energetic coach who uses a non-judgmental approach and proven coaching tools, techniques, and frameworks to enable clients to advance in their thinking, ideas, goals, and aspirations to unlock their true potential. As an educator, Dr. Gathoni is a data science professor at the University of Maryland Global Campus. Dr. Gathoni is the Academic Chair for PharmaSUG 2024.
|
 |
Ajay Gupta
Ajay Gupta is an Associate Director at Daiichi Sankyo. He has around 17 years of experience as data standard lead, project lead, technical lead, and system developer in CRO/Pharmaceutical industry. He received his master's degree in Biomedical Engineering from Louisiana Tech University in 2006. Since 2010, he has been a regular presenter at SAS conferences. He is interested in topics related to CDISC, RWD/RWE, Spotfire, R, Python, Pinnacle21, Visual Basic for Applications, SAS Grid and SAS Application development.
|
 |
Vineet Jain
Vineet Jain is a seasoned expert in the field of clinical research, with over 17 years of experience supporting statistical programming, statistics, and data management. He is the Founder and CEO of Nimble Clinical Research, a company that provides statistical services to the pharmaceutical, biotechnology, and medical device industries. Vineet's background in computer science, statistics, and machine learning gives him a unique perspective on the use of technology in clinical research. Vineet has established Nimble Clinical Research as a leading provider of clinical research solutions, leveraging cutting-edge technology and industry expertise to deliver high-quality results to clients.
|
 |
Kirk Paul Lafler
Kirk Paul Lafler is a SAS, SQL and Python consultant, application developer, programmer, and educator; an adjunct professor at San Diego State University; an advisor and adjunct professor at the University of California San Diego Extension; and teaches SAS, SQL, Python, Excel and cloud-based courses, workshops, and webinars around the world. Kirk has been a SAS consultant, application developer, and programmer since 1979; an SQL user since 1985; a Python programmer since 2017, and an author of several books including, Exploratory Data Analysis (EDA) By Example (PB&J Press. 2023) and PROC SQL: Beyond the Basics Using SAS, Third Edition (SAS Press. 2019) along with numerous papers and articles on a variety of SAS, SQL, and Python topics. Kirk has served as an Invited speaker, educator, keynote, and section leader at SAS conferences; and is the recipient of 27 “Best” contributed paper, hands-on workshop (HOW), and poster awards.
|
 |
Mark Pittman
For the past three decades, Mark Pittman has been focused on bringing efficient processes together with effective communication. Now, working with the cutting-edge AI-driven Medical Writing tool, ZYLiQ, Mark is able to share how AI is effectively impacting the completion of CSRs and getting FDA submissions across the finish line weeks ahead of schedule.
|
 |
Liping Sun
Liping Sun is a Statistical Analyst at the FDA, working in the Division of Analytics and Informatics within the Office of Biostatistics in CDER (Center for Drug Evaluation and Research). She has both medicine and statistics background. She is interested in enhancing data quality and implementing data standards to improve review experience for statistical reviewers and analysts. She is involved in efforts to improve the implementation and utilization of data standards within the agency, as well as participating in outside agency collaborations. Before joining the FDA, she performed data analysis for academic epidemiology research at the NIH (National Institutes of Health).
|
 |
Sabarinath Sundaram
Sabarinath Sundaram has over 10 years of statistical programming experience working in exploratory research studies to Phase III studies, CDISC standards, handling PK/PD/ADA data, and across multiple therapeutic areas. He has a Ph.D. degree in Life Sciences (Biochemistry). He is the Principal Statistical Programmer at Seagen, Inc. as well as PK/PD center of excellence lead.
|
 |
Sushant Thakare
Sushant Thakare is an accomplished pharmaceutical professional with more than 16 years of experience in the industry. Currently serving as an Associate Director at AstraZeneca, he has made significant contributions in the vaccine and immune therapy unit. Notably, Sushant led the successful submission of a Biologics License Application (BLA) to the FDA, showcasing his expertise in regulatory compliance. He has actively participated in regulatory responses and served as a valuable member of the FDA Ad-comm AZ team. Sushant is responsible for overseeing the Statistical Programming team, ensuring the efficient execution of projects under his purview.
|
 |
Richann Watson
Richann Watson is an independent statistical programmer and CDISC consultant based in Ohio. She has been using SAS since 1996 and specializes in analyzing clinical trial data and implementing CDISC standards. She is a member of the CDISC ADaM team and various sub-teams. She has presented numerous papers, posters, and training seminars at various conferences. Richann holds a bachelor’s degree in mathematics and computer science and master’s degree in statistics.
|
 |
Diane Wold
Diane Wold received her Ph.D. in Statistics from the University of North Carolina at Chapel Hill. She worked for Burroughs Wellcome/Glaxo Wellcome/Glaxo Smith Kline in a variety of roles for over 30 years. At the Glaxo Smith Kline merger, she joined the data standards group, and in 2002 she joined the CDISC SDS team. She was also involved in other CDISC teams, including the Protocol Representation Group and SHARE. In 2012 she became involved in the CFAST initiative to develop therapeutic area standards. In 2015 she joined CDISC as an employee. Among other activities, she is currently working on SDTM variable definitions, SDTM variable roles, and the CDISC Knowledge Base.
|
 |