With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.
In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.
Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer.
Functional Goal:
Sponsor accountable representative according to ICH and GCP principles in charge of the oversight of statistical programming activities outsourced to external partners. Provision of statistical programming expertise from clinical study set up to submission of clinical data packages to Regulatory Agencies. Accountability for technical acceptance of clinical data packages (in CDISC format or other required format) by Regulatory Agencies. Responsible for the programming or oversight of clinical outputs required to support Regulatory questions up to Regulatory approval and for outputs supporting Medical Affairs requests. Support to the development of internal programming processes and tools, including automation of specific tasks. Management of the clinical data repository and data analysis platform and other data exchanges tools. Accountability for Programming KPIs. Programming representative for Regulatory Inspections.
Main Tasks:
Other Tasks:
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