Senior CDISC Statistical Programmer Lead

PharmaLex; Lisboa; On-site; EUR 90,000 - 120,000; Full time

Job summary

Cencora is seeking a Senior Statistical Programmer (CDISC focus) to lead CDISC data standards and programming efforts across internal and external teams. The role emphasizes SDTM/ADaM, regulatory submission readiness, and governance of CDISC datasets using SAS and R.

The position requires substantial experience with regulatory components (Define.xml, SDRG, ADRG) and an ability to manage multiple study data activities while driving automation and training across the programming ecosystem.

Qualifications

• Master's or Bachelor with extensive CDISC regulatory exposure.
• Hands-on regulatory submission work with eCTD favored.
• Experience developing SDTM/ADaM datasets from raw data.

Responsibilities

• Lead CDISC dataset specs, SDTM/ADaM and governance.
• QC CDISC datasets, TFLs, and submission-ready outputs.
• Prepare Define.xml, SDRG, ADRG for regulatory filings.
• Perform SAS/R programming ensuring CDISC compliance.
• Drive process improvements and internal CDISC training.

Skills

CDISC-compliant programming

SAS

R

SDTM/ADaM

regulatory submissions

project management

Define.xml/SDRG/ADRG

Education

Master's in Statistics/Biostatistics/Data Science

6+ years clinical statistical programming

Tools

SAS

R

Job description

Cencora is seeking a Senior Statistical Programmer (CDISC focus) to lead CDISC data standards and programming efforts across internal and external teams. The role emphasizes SDTM/ADaM, regulatory submission readiness, and governance of CDISC datasets using SAS and R.

The position requires substantial experience with regulatory components (Define.xml, SDRG, ADRG) and an ability to manage multiple study data activities while driving automation and training across the programming ecosystem.