Senior Statistical Programmer – CDISC SDTM/ADaM Expert

PharmaLex; Madrid; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Cencora is seeking a Senior Statistical Programmer (CDISC focus) to lead CDISC data standards, coordinate programming activities, and support regulatory submissions across CDISC SDTM/ADaM. The role requires strong SAS programming and project leadership within multi-disciplinary teams.

The candidate will ensure high-quality datasets, documentation, and deliverables for FDA/EMA submissions, while contributing to process improvements and cross-border collaboration with affiliates.

Formación

• Extensive CDISC-compliant statistical programming experience.
• Proven ability to prepare data for regulatory submissions.
• Strong communication and collaboration with cross-functional teams.

Responsabilidades

• Lead CDISC dataset specifications for SDTM/ADaM and governance.
• QC CDISC datasets, TFLs, and submission-ready outputs.
• Perform SAS/R programming ensuring regulatory alignment.
• Prepare Define.xml, SDRG/ADRG and other regulatory documents.
• Support process improvements and internal training for CDISC programming.

Conocimientos

CDISC expertise

SAS programming

R programming

Data standards governance

Project management

Regulatory submissions

Educación

Master's degree in Statistics / Biostatistics / Data Science

6+ years clinical statistical programming

Herramientas

SAS

R

Descripción del empleo

Cencora is seeking a Senior Statistical Programmer (CDISC focus) to lead CDISC data standards, coordinate programming activities, and support regulatory submissions across CDISC SDTM/ADaM. The role requires strong SAS programming and project leadership within multi-disciplinary teams.

The candidate will ensure high-quality datasets, documentation, and deliverables for FDA/EMA submissions, while contributing to process improvements and cross-border collaboration with affiliates.