Senior SAS Developer

Certara; Germany (OH); On-site; USD 120,000 - 160,000; Full time

Job summary

Certara is seeking a Senior SAS developer to support Clinical Data Automation in a regulated life sciences environment. Strong SAS, R, and/or Python skills are required to design automated data workflows.

You will work with SDTM/ADaM datasets, Define.xml, and CDISC standards to ensure submission readiness and data quality across studies.

The role emphasizes reusable macros, automation frameworks, and collaboration with cross-functional teams to deliver scalable data solutions.

Qualifications

• 6+ years of Clinical trials SAS programming experience.
• Experience with Pinnacle 21 validation and Define.xml.
• CDISC SDTM/ADaM standards expertise.
• Define.xml creation and submission readiness.

Responsibilities

• Clinical Programming using SAS with R/Python as needed.
• Work with SDTM/ADaM datasets and Define.xml.
• Ensure CDISC standards for data standardization and validation.
• Develop reusable programming standards and automation frameworks.
• Collaborate with cross-functional teams to automate data quality checks.

Skills

SAS programming

R programming

Python programming

Clinical automation

CDISC SDTM/ADaM

Pinnacle 21

Data validation

Metadata-driven programming

Define.xml

APIs/workflows

Regulatory submission readiness

Macros/utilities

Data quality checks

Education

BSc/MSc Biostatistics or Life Sciences

Tools

Pinnacle 21 / P21 Enterprise

Job description

About Certara

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.

Overview

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.

Our goal is to 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. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization.

We are seeking a highly skilled Senior SAS developer to support Clinical Data Automation with strong experience in SAS, R, and/or Python to support the development of automated clinical data workflows within a regulatory life sciences environment.

This role is ideal for a candidate who 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.

The position requires a strong understanding of CDISC standards, clinical trial data structures, regulatory submission expectations, and practical programming approaches to automate repeatable data quality and validation workflows.

Responsibilities

• Clinical Programming and Standards
• 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.

Data Flow Automation and P21 Integration

• 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.

Application Development and Technical Implementation

• 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.

Qualifications

• 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 is required.
• 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, attention to detail, accountable to quality and timely delivery.
• Ability to work on multiple collaborative projects, team player mentality.
• Experience with the R software platform (in addition to SAS) is a plus.

Key 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

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.