01 oct
|
Jobrapido
|
Barcelona
01 oct
Jobrapido
Barcelona
Overview In this role, you will lead the design, development, and QC of SAS programs to create ADaM datasets, tables, figures, and submission packages. You collaborate with study teams to ensure submission-ready data (SDTM/ADaM) and oversee complex analyses and data delivery for regulatory submissions. You will drive efficiency by developing global tools and leading programming activities across multiple studies.
This is a hands-on, impact-oriented position within a cross-functional environment that shapes how data supports regulatory decisions and publications.
Responsabilidades
- Design data structure and specifications for ADaM datasets, tables, figures, listings, and submission content
- Ensure submission readiness and data quality for SDTM, ADaM, tables, figures, listings, and define.xml
- Lead pooled and exploratory analyses, working with statistics leads and programming teams
- Oversee ISS and ISE dataset specification and delivery when not provided by CRO
- Design and implement complex SAS programs for CDISC ADaM data analysis and reporting
- Develop general tools to improve efficiency and capacity of the Statistical Programming group
- Coordinate with study teams to meet timelines and deliver high-quality outputs
- Collaborate with CR&D; for data analysis requests; support regulatory responses, integrated summaries, publications, and exploratory analyses of available data
Requisitos principales
- 5+ years in clinical programming and/or statistical programming in CRO/pharmaceutical environments
- Deep understanding of clinical programming processes and standards
- Extensive SAS programming experience including SAS Macros
- Strong programming and problem-solving skills
- Proficient in R programming (hands-on)
- Advanced knowledge of CDISC standards (CDASH, SDTM, ADaM)
- Proven experience leading programming activities for pooled and exploratory analyses across multiple studies
- Ability to work independently or in teams and manage timelines
- Experience in cross-functional, multicultural, international clinical trial teams
- collaboration
- communication
- problem-solving
- SAS programming
- SAS Macros
- R programming
📌 Senior Statistical Programmer - FSP (Barcelona)
🏢 Jobrapido
📍 Barcelona