Senior Principal Statistical Programmer (Remote)

About the role

The Senior Principal Statistical Programmer serves as a senior technical leader and subject matter expert in statistical programming, with deep expertise supporting clinical trials and Data Monitoring Committee (DMC) deliverables. This role combines advanced hands-on programming capabilities with technical leadership, driving the design, development, and standardization of high-quality statistical outputs.

Responsibilities

• Serve as a senior technical expert in statistical programming, providing guidance across multiple studies or functional areas.
• Design, develop, validate, and oversee complex statistical programming deliverables, including analysis datasets, tables, listings, and figures.
• Lead the development, validation, and continuous improvement of DMC macros and programming standards.
• Provide technical oversight and review of programming work to ensure quality, compliance, and consistency across deliverables.
• Drive the establishment and adoption of programming standards, best practices, and process improvements.
• Collaborate with biostatistics and study teams to support complex trial designs, analyses, and DMC reporting.
• Independently manage and prioritize programming activities across multiple studies or initiatives.
• Mentor and provide technical leadership to statistical programming staff, supporting skill development and best practices.
• Contribute technical expertise to proposals, project planning, and scope discussions as needed.
• Partner with IT and technology teams to support SAS environments, tools, and system validation efforts.
• Provide technical oversight for programming activities supporting regulatory submissions and inspection readiness.
• Ensure programming deliverables align with regulatory expectations, submission requirements, and CDISC standards.
• Influence programming approaches, standards, and best practices across multiple studies or programs.
• Serve as a technical escalation point for complex programming, data, or deliverable issues, leading resolution of highly complex or ambiguous challenges.
• Provide expert interpretation of statistical analysis plans (SAPs), protocols, and study documents, translating requirements into programming strategy.
• Champion process improvements, automation, and innovative approaches to enhance efficiency, scalability, and consistency of programming deliverables.

Qualifications/Experience

• Minimum 8–10 years of statistical programming experience in a clinical trial environment.
• Deep expertise in SAS programming, including complex analyses and regulatory deliverables.
• Proficiency in R programming is a must.
• Demonstrated experience with CDISC standards and regulatory requirements.
• Proven ability to independently lead complex programming efforts across studies.
• Experience mentoring staff and driving technical standards or best practices.
• Demonstrated ability to independently coordinate biostatistical projects, including planning and oversight of programming activities, with minimal direction from senior leadership.