Lead CDISC Programmer SDTM/ADaM Expert

PharmaLex; Warszawa; On-site; PLN 230,000 - 320,000; Full time

Job summary

Cencora is seeking a Senior Statistical Programmer with CDISC expertise to lead regulatory data packages and SDTM/ADaM development across cross-functional teams.

The role emphasizes SAS and R programming, CDISC standards governance, and preparation of Define.xml, SDRG, ADRG for FDA/EMA submissions, with remote collaboration across international teams.

You will drive process improvements, support data management, and help train staff in modern programming practices.

Qualifications

• 6+ years in clinical statistical programming with regulatory submission experience.
• Expert-level SAS with SDTM/ADaM development from raw data.
• Experience with eCTD submissions and regulatory expectations.
• Strong communication and project management skills.
• Ability to lead CDISC governance and training initiatives.

Responsibilities

• Lead SDTM and ADaM dataset development and data set specifications.
• QC CDISC datasets and TFLs for regulatory submission.
• Prepare Define.xml, SDRG, ADRG and other submission documents.
• Perform statistical programming in SAS and R for CDISC datasets.
• Collaborate with statisticians and data management across teams.

Skills

CDISC programming

SAS programming

R programming

Project management

Documentation skills

Quality assurance

Education

Master's degree in Statistics

Bachelor’s degree in related field

Tools

SAS

R

Job description

Cencora is seeking a Senior Statistical Programmer with CDISC expertise to lead regulatory data packages and SDTM/ADaM development across cross-functional teams.

The role emphasizes SAS and R programming, CDISC standards governance, and preparation of Define.xml, SDRG, ADRG for FDA/EMA submissions, with remote collaboration across international teams.

You will drive process improvements, support data management, and help train staff in modern programming practices.