Senior SAS Developer

About the role

Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. We enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development.

We are seeking a highly skilled Senior SAS developer to support Clinical Data Automation with strong experience in SAS, R, and/or Python. This role combines traditional clinical statistical programming expertise with hands-on application development, data pipeline automation, and standards-driven clinical data validation experience. The successful candidate will help design, build, and maintain automated data flow processes that support CDISC-compliant data standardization, validation, issue detection, and integration with P21 Enterprise/MDR library or similar clinical data validation systems.

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 associated 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 to ensure regulatory and internal standards 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.
• Develop utilities to standardize clinical datasets and metadata before validation and model/data review.
• Support automation of repeatable data quality checks across studies, programs, and therapeutic areas.
• Partner with cross-functional teams to identify manual programming or validation steps that can be converted into scalable automated workflows.
• Use SAS, R, Python, APIs, scripting, or workflow tools to build automation solutions for clinical data processing and validation.
• Develop modular, maintainable, and well-documented code that can be reused across studies and projects.
• Support integration between clinical data repositories, programming environments, P21 systems, metadata repositories, dashboards, and reporting tools.
• Collaborate with technology, data standards, statistical programming, biometrics, and clinical operations teams to define requirements and implement practical solutions.
• Contribute to the design of dynamic systems that can ingest data, apply standards, run validation, generate outputs, and support downstream review.

Requirements

• B.Sc., M.Sc., or equivalent education in Biostatistics/Statistics, Bioinformatics, Life Sciences, Mathematics, Physical Sciences, or related fields.
• 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, as well as annotating CRFs, creating specifications for SDTM and ADaM datasets.
• Experienced in creating Define.xml and the corresponding Reviewers’ Guide for SDTM and ADaM datasets.
• Good verbal and written communications skills in English.
• Demonstrated knowledge of clinical drug development.
• Proficiency in conducting advanced statistical analyses.
• Must be independent, detail-oriented, accountable to quality and timely delivery.
• Ability to work on multiple collaborative projects with a team player mentality.
• Experience with the R software platform (in addition to SAS) is a plus.

Skills

• SAS programming
• R and/or Python programming
• Clinical trial 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 improvement