09 sep
|
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.
Responsibilities
Program, QC, and maintain SDTM and ADaM datasets in SAS in accordance with CDISC standards
Coordinate programming deliverables, timelines, and dependencies across sponsor stakeholders and external vendors
Provide oversight of vendor programming activities, including review of specifications, deliverables, and issue resolution
Support CDISC-compliant submission deliverables (e.g., define.xml support and dataset-level metadata) in collaboration with internal teams and vendors
Lead programming workstreams by planning, tracking, and communicating status/risks for SDTM and ADaM deliverables
Perform SDTM and ADaM mapping/derivations and ensure traceability from source to analysis datasets
Apply and maintain study standards for SDTM and ADaM implementation (structures, variables,
controlled terminology) across internal and vendor outputs
Drive issue management for SDTM/ADaM deliverables (e.g., review findings, validation queries, and remediation) through to closure
Perform senior review and QC of SDTM and ADaM datasets and associated documentation, including vendor deliverables
Create, QC, and maintain SDTM and ADaM dataset specifications and ensure alignment with study standards and vendor outputs
Qualifications
Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
SAS & R Programming experience within the Pharmaceutical or CRO industry
Knowledge of SDTM and ADaM CDISC standards
Why Join Us
Remote working and adaptable working hours
Career development, mentorship, and continuous learning
Supportive, friendly, and collaborative culture
Making a Positive Impact: As a B-Corp™ organization, we are committed to sustainabi
📌 Senior Statistical Programmer (España)
🏢 PHASTAR
📍 España