This function is comprised of a number of sub-functions:
The Biostatistics Department provides statistical guidance and strategic direction in the design of interventional and non-interventional clinical trials, existing data projects, product development programmes and value evidence generation packages. We undertake the statistical analysis and reporting of these clinical research activities, contribute to the interpretation and the publication results in the medical literature and conference presentations. Our global function consists of statisticians based in the US, Canada and the UK.
The Epidemiology Department undertakes the design, analysis and reporting of epidemiological studies and provides epidemiological advice and support to observational research activities within R&D functions and corporate affairs. We make use of large medical care databases held in-house and supported by a team of programmers. In addition, we work more generally to promote the understanding and effective use of observational research to inform and complement our drug development programs, clinical trials and value evidence generation programs. Our global function includes epidemiologists, analysts and statistical programmers based in the US and the UK.
The Statistical Programming Department develops innovative software to analyse and report on clinical study data in support of scientific research and regulatory submissions. Our aim is to use leading edge technology including SAS®, S-PLUS® and the internally developed SDF system to generate validated statistical outputs and analysis datasets (CDISC compliant SDTM and ADaM) to the highest quality in compliance with internal SOPs and external regulatory guidelines. Partnering with Biostatistics, CDM, Epidemiology and Clinical, GSP (Global Statistical Programming) has statistical programmers, developers and Infrastructure Programmers based in the US and the UK.
The Clinical Data Management Department is a global function that collects and manages the data generated during the conduct of Amgen’s global clinical trials, from phase 0 through to phase 4. Our aim is to provide a clean and complete dataset, on time and with quality, to our Biostatistics and Statistical Programming Departments for analysis and reporting. We are split into two main groups: CDM Systems & the Therapeutic Area Teams. CDM Systems are responsible for developing the data capture tools and databases; whilst the Therapeutic Area Teams are responsible for the management of the data and are members of the Global Clinical Study Teams.
The Operations department is a global function that partners with Biostatistics, Epidemiology, Statistical Programming and CDM to support various project management, process improvement, performance management and regulatory compliance efforts. Our global function is based in the US and UK.
