SAS Macro Developer, Senior Manager

Location: Remote/Hybrid

The Lead SAS Macro Developer at the Senior Manager level will drive the design, development, and maintenance of enterprise-level SAS macros, with a primary focus on TLF (Tables, Listings, and Figures) programming workflows, alongside support for SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model). This role requires a strong technical background in SAS programming and a deep understanding of the Software Development Life Cycle (SDLC) in a regulated (GxP) environment. The incumbent will play a critical role with a dedicated focus on advanced SAS macro development, automating and standardizing Statistical programming tasks to improve efficiency, quality, and compliance in regulatory submissions across the global portfolio.

In this role, a typical day might include the following:

• Lead the design, development, and implementation of complex, reusable, and dynamic SAS macros to streamline programming workflows, with a primary emphasis on TLFs. Contribute to the long-term automation strategy.

• Ensure all macro development, testing, and validation activities strictly adhere to formal SDLC processes and 21 CFR Part 11 / GxP compliance standards. Establish and enforce best practices.

• Spearhead the development of automated tools for data transformation, variable derivation, metadata generation, and quality control checks.

• Direct the testing and validation of macros, ensuring robust functionality and resolving complex bugs. Author and review comprehensive validation documentation.

• Partner with statistical programmers, biostatisticians, and other subject matter experts to understand business requirements and translate them into scalable technical solutions.

• Mentor junior developers and programmers. Document macro code, usage instructions, and best practices. Lead training initiatives for the broader biometrics team on leveraging the developed macros.

• Drive the optimization of macro performance to ensure scalability and maintainability across large, complex clinical trial datasets.

• Provide expert-level support to study teams specifically for the integration, adoption, and troubleshooting of enterprise macros particularly during TLF generation.

This Role May Be For You If Have

• Experience with Pinnacle 21 for CDISC validation. Familiarity with R, Shiny, or Python is highly preferred.

• Extensive experience and deep understanding of working in an SDLC-compliant manner within a regulated environment, including strong software validation and documentation practices.

• Deep understanding of the clinical drug development process and comprehensive knowledge of CDISC standards (SDTM, ADaM, Define-XML) and regulatory submission requirements (e.g., FDA, EMA).

• Exceptional analytical skills with the ability to design modular, reusable, and maintainable technical architectures and drive innovation.

• Excellent verbal and written communication skills in English, with the ability to effectively collaborate with cross-geographical global teams and influence technical strategy.

Experience: 12+ years of progressive experience in SAS programming within the pharmaceutical, biotechnology, or CRO industry. Must have at least 5 years of pure, dedicated SAS macro development experience. Expert-level proficiency in SAS/BASE and SAS/MACROS, with a strong ability to write complex, dynamic macros using advanced macro language features.

Your Success Matters to Us

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).