pIn 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. /pulliProgram and validate output (tables, listings, figures) for clinical studies and regulatory/market access requests /liliSupervise generation of SDTM/ADaM datasets and related documents in CDISC compliance and CRO outputs /liliDevelop standard SAS macros,



templates and validation documents /liliCollaborate with Statistian to prepare tables/listings per specification documents /liliInteract with Data Manager for data cleaning and external data management /liliCoordinate with Drug Safety Unit to evaluate pharmacovigilance data /liliLead development, maintenance and adherence to divisional SOPs and guidelines /lili3-5 years in a CRO or pharmaceutical company with clinical trials experience /liliSolid understanding of theoretical and applied statistics and regulatory guidelines in pharma /liliExpert in development and submission of NDA /liliCDISC standards knowledge, GCP preferred /liliProficiency in SAS System; R and/or SQL as options /liliable to interact with all levels of the organization /liliSAS System programming /liliCDISC SDTM/ADaM knowledge /li /ul #J-18808-Ljbffr

📌 Sas Programmer (Bardi)
🏢 EUSA Pharma
📍 Bardi