Accelerating CSR Timelines: Applying Real-Time Data, Governed Standards and Expert Oversight

(Moderator) Emma Bickford, Senior Director Biostatistics, IQVIA

Emma Bickford is a Senior Director of Biostatistics at IQVIA with 29 years of industry experience. As Chief of Staff, she is an active member of the Global Biostatistics senior leadership team and has a proven track record in setting and delivering on strategy, including leading process improvement initiatives and driving innovation adoption to support Real Time Data Analysis (RTDA). Before her current role, Emma line-managed a large team of statistical team leads. Her expertise also extends to a two-year period serving on the Biostatistics SOP team, during which she led a groundbreaking and highly successful Lean Sigma project. This initiative resulted in the development of a new SAP template and year-on-year improvement in the quality of SAPs produced. Emma’s dedication to continuous improvement and innovation ensures that the Biostatistics department remains at the forefront of excellence.

Karen Zieker, VP Biostatistics, IQVIA

Karen Zieker brings more than two decades of experience in the clinical development industry to her role as IQVIA’s Vice President, Global Head of Biostatistics and Programming. Her team utilizes their therapeutic, statistical and programming expertise to ensure high-quality and timely delivery of statistical analysis deliverables for Phase I- Phase III trials. Karen is trained in quality improvement methodologies and brings that knowledge and experience to her role to improve quality and make processes more efficient. Her prior experiences include leading statistical programming study teams, and pharma partnership management.

Dries Becker, Associate Director Statistical Programming, IQVIA

Dries Becker is an Associate Director of Statistical Programming at IQVIA, with 18 years of experience in the clinical research industry. He leads biostatistics and cross-functional optimization initiatives within the Business Solutions group and manages a team of programmers and statisticians across regions and client portfolios.

Dries has held key leadership roles, including head of the European programming group and also headed up the biostatistics data visualization group for a decade. In this role, he delivered tailored medical data review solutions to medical teams across multiple client partnerships. His earlier experience includes leading statistical programming project teams across multiple indications and study phases in complex, multi-national environments.

Paul Slagle, Senior Director Statistical Programming, IQVIA

Paul Slagle is the Senior Director of Global Data Standards Management at IQVIA. He has led multiple teams in the implementation and use of CDISC and other standards over the last 10 years. Paul is also an active member of the CDISC Standards team in leading the development of the ADaM Oncology Examples Document and multiple CDISC Therapeutic Users Guidance’s. He has also contributed to the SDTM Standards development. Before working and leading the development of standards teams, Paul led the Statistical Programming team at a few CRO’s and built the Statistical Programming team at a remote site for one CRO. Paul has been working in the pharmaceutical industry for over 20 years and, prior to that, worked in the R&D department for food manufacturing for almost 20 years. Paul is a member of the PharmaSUG Executive Committee and the 2023 Chair for the PharmaSUG Annual Conference in San Francisco.