Principal C&SP Methodology Lead

About the role

The Principal C&SP Methodology Lead is a senior technical programmer/developer responsible for driving technical strategy, innovation, and automation within Clinical and Statistical Programming. The role focuses on research, emerging technologies, and the development of standard tools to improve efficiency and quality of clinical data processes.

Key responsibilities

• Lead technical projects and provide expertise for Clinical and Statistical Programming, including research and innovation in emerging spaces.
• Identify, evaluate, and develop automation solutions (e.g., SAS macros, R functions/packages) to enhance data management, risk‑based monitoring, statistical analysis, visualization, and regulatory submissions.
• Collaborate with internal and external stakeholders to propose and implement innovative technical solutions.
• Design and support global technical solutions, including documentation and training materials.
• Provide functional leadership, talent development, and performance management for assigned personnel.

Required profile

• Bachelor’s degree or equivalent in computer science, data science, mathematics, public health, or related field.
• 6‑8 years of programming experience with increasing responsibility, including software development and testing.
• Experience in a matrix environment and strong communication skills.
• Knowledge of health authority guidelines (ICH‑GCP, 21 CFR Part 11) and clinical R&D concepts.

Required skills

• SAS programming and SAS macros
• R programming and R packages
• Python programming
• Knowledge of CDISC standards, SDTM, ADaM, and controlled terminology
• Software development life cycle (SDLC) and DevOps tools