We are currently looking for a Senior SAS programmer. Reporting directly to the Global Head of Biometrics, you will provide support to all Vifor Pharma clinical studies and statistical projects.
Within this function, you will:
Act as the SAS programmer representative in clinical study and project teams and provide SAS programming expertise
Coordinate and monitor outsourced SAS programming activities
Review and approve the SAS programming deliverables, including programming of SDTM, ADaM and outputs production, and the preparation of the technical documents (specifications)
Ensure that quality control is performed on all programs, and that the outputs meet quality standards and project requirements
Lead the development and the update of the biometrics standards and SOPs
Coordinate and contribute to the preparation of the FDA and EMA submission filing or responses to the health authorities
Participate in the preparation of the integrated analyses of safety and efficacy (ISE/ISS)
Provide strategical input to and lead SAS programming activities
Prepare, plan and run SAS programming activities according to the projects timelines
Manage all technical documentation such as SDTM, ADaM, good programming practices, and Open CDISC validation reports associated to the development of SAS programs across all SAS programming activities.
YOUR PROFILE:
The successful candidate holds a University level degree (BSc or higher level) in health related field and/or computational science (Degree in Biology or biostatistics would be an advantage) and brings additionally the following knowledge and experience:
3 to 5 years of statistical programming experience in clinical trials
3 to 5 years of SAS programming experience, using SAS BASE, STAT, MACRO and GRAPH
Demonstrated and applied experience in the use of CDISC standards (SDTM and ADaM)
Good knowledge of GCPs, including local laws, ICH and other regulatory guidelines (in particular eCFR part 11 compliant)
Basic or advance knowledge of statistical principles and methods
Experience managing CROs and experience in the technical validation and installation of SAS or other programming tools are an asset
Abilities to develop, update and/or maintain complex SAS macros
Fluent English both written and spoken
Die Vifor Pharma Gruppe ist ein globales Pharmaunternehmen. Sie nimmt in allen ihren Kern-geschäften eine führende Position ein und besteht aus den folgenden Unternehmen: Vifor Pharma und Vifor Fresenius Medical Care Renal Pharma (ein Gemeinschaftsunternehmen mit Fresenius Medical Care). Die Vifor Pharma Gruppe ist an der Schweizer Börse kotiert (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
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