12 oct
|
PHASTAR
|
España
As a Senior Statistical Programmer, you will be working embedded within the sponsor FSP team, delivering SAS programming in line with CDISC standards (SDTM and ADaM). The role focuses on vendor oversight and end-to-end project coordination to ensure high-quality, on-time clinical data deliverables.ResponsibilitiesProgram, QC, and maintain SDTM and ADaM datasets in SAS in accordance with CDISC standardsCoordinate programming deliverables, timelines, and dependencies across sponsor stakeholders and external vendorsProvide oversight of vendor programming activities, including review of specifications, deliverables, and issue resolutionSupport CDISC-compliant submission deliverables (e.g., define.xml support and dataset-level metadata) in collaboration with internal teams and vendorsLead programming workstreams by planning, tracking, and communicating status/risks for SDTM and ADaM deliverablesPerform SDTM and ADaM mapping/derivations and ensure traceability from source to analysis datasetsApply and maintain study standards for SDTM and ADaM implementation (structures, variables,
controlled terminology) across internal and vendor outputsDrive issue management for SDTM/ADaM deliverables (e.g., review findings, validation queries, and remediation) through to closurePerform senior review and QC of SDTM and ADaM datasets and associated documentation, including vendor deliverablesCreate, QC, and maintain SDTM and ADaM dataset specifications and ensure alignment with study standards and vendor outputsQualificationsEducated to BSc or above within Computer Science, Mathematics or a Science related disciplineSAS & R Programming experience within the Pharmaceutical or CRO industryKnowledge of SDTM and ADaM CDISC standardsWhy Join UsRemote working and versátil working hoursCareer development, mentorship, and continuous learningSupportive, friendly, and collaborative cultureMaking a Positive Impact: As a B-Corp organization, we are committed to sustainability, solid responsibility
📌 Senior Statistical Programmer (España)
🏢 PHASTAR
📍 España