02 oct
|
Jobrapido
|
Barcelona
02 oct
Jobrapido
Barcelona
Overview
Compruebe que cumple con los requisitos de habilidades para este puesto, así como con la experiencia asociada, y luego envíe su CV a continuación.
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 integral 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
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- 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