Senior SAS Developer: Data Automation & CDISC Expert

Certara; United Kingdom; On-site; GBP 70,000 - 110,000; Full time

Job summary

Certara is seeking a Senior SAS developer to support Clinical Data Automation in a regulatory life sciences environment. You will design, build and maintain automated data flows using SAS, R and/or Python, ensuring CDISC SDTM/ADaM standards are met and Define.xml is generated with Pinnacle 21 validation.

The role emphasizes reusable code, automation frameworks, and collaboration with cross-functional teams to enable submission-ready data and high-quality analyses.

Qualifications

• At least 6 years of clinical trials related work experience in SAS programming, analysis and reporting in the context of drug development projects.
• Well experienced in the Pinnacle 21 validation process, generating Define.xml using Pinnacle 21.
• Extensive experience in implementing CDISC standards, annotating CRFs, creating specifications for SDTM and ADaM datasets.
• Experience creating Define.xml and the corresponding Reviewers’ Guide for SDTM and ADaM datasets.
• Good verbal and written communication skills in English.

Responsibilities

• Develop, validate and maintain clinical trial programming deliverables using SAS, with additional use of R and/or Python where appropriate.
• Work with clinical trial datasets including SDTM, ADaM, Define.xml, Reviewer’s Guides and submission packages.
• Apply strong knowledge of CDISC standards to support data standardization, transformation, validation and submission-readiness activities.
• Review clinical data structures, metadata, controlled terminology, mapping specifications and validation outputs for compliance.
• Support development and maintenance of reusable programming standards, macros, utilities and automation frameworks.
• Design and build automated data flow processes to support ingestion, standardization, validation and reporting of clinical study data.

Skills

SAS programming

R and/or Python programming

Clinical data automation

CDISC SDTM and ADaM

Pinnacle 21 / P21 Enterprise

Clinical data validation

Metadata-driven programming

Define.xml and submission standards

Data flow automation

API or workflow integration

Regulatory submission readiness

Reusable macro and utility development

Data quality checks and issue tracking

Clinical programming process improving

Education

B.Sc., M.Sc. or equivalent education in Biostatistics/Statistics, Bioinformatics, Life Sciences, Mathematics, Physical Sciences or related fields

Job description

Certara is seeking a Senior SAS developer to support Clinical Data Automation in a regulatory life sciences environment. You will design, build and maintain automated data flows using SAS, R and/or Python, ensuring CDISC SDTM/ADaM standards are met and Define.xml is generated with Pinnacle 21 validation.

The role emphasizes reusable code, automation frameworks, and collaboration with cross-functional teams to enable submission-ready data and high-quality analyses.