Principal Statistical Programming Lead – Clinical & Statistical Programming

About the role

The Principal Statistical Programming Lead will drive the design, development, and delivery of complex clinical programming solutions for innovative medicine projects, ensuring high‑quality, on‑time outputs across multiple therapeutic areas.

Key responsibilities

• Design and develop efficient programs for critical clinical research analysis, including urgent on‑demand requests.
• Provide technical guidance and mentorship to programming team members, ensuring compliance with departmental processes.
• Oversee programming activities, including matrix leadership of multiple teams and coordination with third‑party vendors.
• Review project requirements, contribute to process improvement initiatives, and adopt new technologies.
• Manage clinical database design, validation, and maintenance, as well as implementation of data tabulation and analysis standards.

Required profile

• Minimum 6 + years of experience in pharmaceutical, CRO or biotech programming.
• Proven ability to lead teams, manage projects, and deliver high‑quality results in a matrix environment.
• Strong communication, influencing, and decision‑making skills.
• Experience managing outsourced programming activities is preferred.

Required skills

• Expert knowledge of SAS (required for clinical programming).
• Proficiency in R and Python for data manipulation and reporting.
• Deep understanding of CDISC standards.
• Familiarity with regulatory guidelines such as ICH‑GCP and 21 CFR Part 11.