Principal C&SP Methodology Lead

About the role

The Principal C&SP Methodology Lead will drive technical strategy and innovation for clinical and statistical programming at Johnson & Johnson. This senior position combines deep programming expertise with leadership of projects and teams to improve automation, efficiency and quality of clinical data processes.

Key responsibilities

• Lead technical projects and develop innovative solutions for clinical and statistical programming, including SAS macros, R functions and Python tools.
• Collaborate with users, data management, biostatistics, IT and external partners to identify automation and continuous‑improvement opportunities.
• Design, document and train on global technical solutions, ensuring adoption across the department.
• Oversee work allocation of internal and external team members and provide coaching.
• Stay current with industry trends, standards (e.g., CDISC, SDTM, ADaM) and regulatory guidelines (ICH‑GCP, 21 CFR Part 11).

Required profile

• 6‑8 years of programming experience with increasing responsibility in clinical or statistical environments.
• Strong project‑management and matrix‑team leadership skills.
• Excellent communication, ability to translate complex problems into clear code.
• Experience with software development life‑cycle, DevOps tools and cloud platforms.

Required skills

• SAS (including macro development)
• R (functions/packages)
• Python
• SDLC and DevOps tooling
• Cloud‑based platform experience
• Knowledge of CDISC standards, SDTM and ADaM