28 set - Bardi
EUSA Pharma
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.
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
3-5 years in a CRO or pharmaceutical company with clinical trials xrdztoy 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
able to interact with all levels of the organization
SAS System programming
CDISC SDTM/ADaM knowledge
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