16 ott - Italia
EUSA Pharma
Overview In this role you will program and validate outputs (tables, listings, figures) to support data cleaning and statistical analyses for clinical studies, regulatory and market access requests. You will oversee SDTM/ADaM datasets and related documents, ensuring CDISC compliance and alignment with CRO outputs. You'll develop SAS macros and templates, and collaborate with statisticians, data managers and pharmacovigilance to maintain SOPs and data standards. This position offers the opportunity to shape statistical programming practices and contribute to regulatory submissions.
Responsabilità
Program and validate output (tables, listings, figures) for clinical studies and regulatory/market access requests
Supervise generation of SDTM/ADaM datasets and related documents in CDISC compliance and CRO outputs
Develop standard SAS macros, templates and validation documents
Collaborate with Statistian to prepare tables/listings per specification documents
Interact with Data Manager for data cleaning and external data management
Coordinate with Drug Safety Unit to evaluate pharmacovigilance data
Lead development, maintenance and adherence to divisional SOPs and guidelines
Requisiti fondamentali
~3-5 years in a CRO or pharmaceutical company with clinical trials experience
~ Solid understanding of theoretical and applied statistics and regulatory guidelines in pharma
~ Expert in development and submission of NDA
~ CDISC standards knowledge, GCP preferred
~ Proficiency in SAS System; R and/or SQL as options
~ collaborative
~ good communicator
~ able to interact with all levels of the organization
~ SAS System programming
~ CDISC SDTM/ADaM knowledge
~ SAS macros development
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