CDISC Lead Statistical Programmer — SDTM/ADaM Expert

myhrabc; España; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Cencora is seeking a highly skilled Senior Statistical Programmer with extensive CDISC-compliant statistical programming expertise. The Statistical Programmer will act as a subject matter expert (SME) in CDISC data standards and coordinate programming activities for regulatory submissions.

You will develop SDTM/ADaM datasets, prepare Define.xml, SDRG, ADRG, and support SDSP development while collaborating with statisticians and data management across internal and external teams.

Formación

• Master's or Bachelor's degree in a quantitative field with significant clinical programming experience.
• Hands-on regulatory submission experience (eCTD) with SDTM/ADaM.
• Experience creating macro libraries, documentation, and SOPs.

Responsabilidades

• Lead development and documentation of CDISC datasets (SDTM/ADaM) and act as SME on CDISC standards.
• QC CDISC datasets, tables, figures and listings for regulatory quality.
• Prepare submission-ready documentation (Define.xml, SDRG, ADRG) per FDA/EMA expectations.
• Collaborate with statisticians and data management to resolve data issues.

Conocimientos

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Project management

Communication skills

Educación

Master's degree in Statistics/Biostatistics/Data Science

6+ years clinical statistical programming experience

Herramientas

SAS

R

Descripción del empleo

Cencora is seeking a highly skilled Senior Statistical Programmer with extensive CDISC-compliant statistical programming expertise. The Statistical Programmer will act as a subject matter expert (SME) in CDISC data standards and coordinate programming activities for regulatory submissions.

You will develop SDTM/ADaM datasets, prepare Define.xml, SDRG, ADRG, and support SDSP development while collaborating with statisticians and data management across internal and external teams.