James reimann, Ph.D.

Genentech

 Since November 2020 James has led the Data Strategy and Delivery organization, which supports clinical trial databases for all Roche pharmaceuticals development programs in late-stage product development and early development (pRED/gRED). The group is accountable for "data as an asset" for the entire clinical development pipeline, adding to the capabilities found in a traditional Data Management organization with a diverse set of additional capabilities (data standards & governance, data pipeline optimization & automation, data curation & integration, data privacy & sharing, external data asset management) that reflect a shift from viewing patient data as an operational step in clinical trials to viewing it as a strategic asset in the age of digital healthcare. The group comprises >300 data professionals in Basel (Switzerland), Mississauga (Canada), South San Francisco (USA), and Welwyn Garden City (UK).

James was raised in South Australia and completed his undergraduate studies in Statistics and Applied Mathematics at the University of Adelaide.  He came to California in 1990 to pursue PhD studies in Statistics at the University of California at Berkeley, during which he first worked for Genentech as Summer Intern in Nonclinical Statistics.  James joined Genentech in 1994 and spent 5 years supporting Clinical Pharmacology and Early-Development for experimental therapies for pulmonology, cardiology, diabetes, and ophthalmology before moving to the oncology therapeutic area. 

James joined the Avastin project in 2000 as was responsible for the first Phase III study of Avastin in breast cancer and later served as the Development filing team leader for the US BLA submission in colorectal cancer.  He then led the biostatistics group supporting the HER projects (Herceptin, Perjeta, and Tarceva) including the US approval for Tarceva in lung cancer.  He then took on positions of increasing responsibility, including Development Team Leader for Herceptin, Genentech head for Avastin Biostatistics, and Global Head of Oncology Biostatistics. Later his remit broadened to include the Patient-Centered Outcome Research group which develops, applies, and analyzes patient-centered endpoints in clinical trials across all disease areas at Roche. After 20 years working in oncology clinical research, James decided to move to a completely different area of quantitative science and took on the role of head of Data Strategy & Delivery as this new organization was being formed, in order to create an increasingly strategic, end-to-end clinical data business that balances primary and secondary data use.