Senior Manager, SAS Macro Developer

Team: IT

Accountabilities:

• Lead the design, development, and maintenance of advanced, reusable SAS macros with a strong focus on TLF generation and clinical programming automation.
• Develop and implement enterprise-level tools for data transformation, QC checks, metadata generation, and workflow optimization.
• Ensure all development, testing, validation, and documentation activities comply with SDLC processes and GxP / 21 CFR Part 11 regulatory standards.
• Drive macro performance optimization to ensure scalability and efficiency across large and complex clinical trial datasets.
• Collaborate with biostatisticians, statistical programmers, and cross-functional teams to translate requirements into robust technical solutions.
• Lead validation efforts, including debugging, testing, and creation of comprehensive technical documentation.
• Mentor and guide junior programmers, while driving training initiatives on macro usage and best practices.
• Provide expert-level support for macro adoption and troubleshooting across study teams during regulatory deliverables.

Requirements:

• 12+ years of experience in SAS programming within pharmaceutical, biotechnology, or CRO environments.
• Minimum 5+ years of dedicated expertise in SAS macro development, including advanced macro language usage and enterprise-scale automation.
• Strong proficiency in SAS/Base and SAS/Macro programming, with experience building complex, dynamic, and reusable macros.
• Deep understanding of clinical drug development processes and CDISC standards (SDTM, ADaM, Define-XML).
• Solid knowledge of regulatory submission requirements (FDA, EMA) and validated system environments (GxP, SDLC, 21 CFR Part 11).
• Experience with Pinnacle 21 for CDISC validation; familiarity with R, Python, or Shiny is an advantage.
• Strong analytical mindset with the ability to design scalable and maintainable programming architectures.
• Excellent communication skills with experience collaborating in global, cross-functional teams.
• Leadership experience in mentoring, training, and guiding technical teams.
• Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or related quantitative field.

Benefits:

• Competitive compensation aligned with senior-level expertise and industry standards.
• Opportunity to lead enterprise-scale automation initiatives in global clinical development.
• Exposure to cutting-edge clinical programming, CDISC standards, and regulatory submissions.
• Strong learning and development opportunities in advanced SAS, automation, and leadership domains.
• Collaborative global work environment with cross-functional clinical and statistical teams.
• Career growth in technical leadership within pharmaceutical R&D and biometrics functions.
• Work on high-impact projects contributing directly to global drug development and regulatory success.