Sr Statistical Programmer

Job Title: Sr. Statistical Programmer

Job Summary

The Senior Statistical Programmer develops, validates, and documents statistical analysis programs to support clinical trial data analysis and regulatory submissions. This role leads programming activities, ensures deliverables meet industry and regulatory standards, and mentors junior programmers. The Senior Statistical Programmer collaborates closely with cross-functional teams, troubleshoots data and programming issues, and advances process improvements to optimize project outcomes.

Job Details/Responsibilities

• Perform and support statistical programming activities, including the development, validation, documentation, and troubleshooting of statistical programs for clinical trial datasets (SDTM/ADaM) and outputs (tables, listings, and figures) supporting regulatory submissions and publications, ensuring timely delivery of high quality and reliable deliverables.
• Conduct comprehensive quality control checks and peer code reviews of programming deliverables to ensure accuracy, consistency, reliability, and compliance with regulatory requirements and programming standards.
• Collaborate with biostatisticians, data managers, and clinical operations, medical affairs, and other cross-functional teams to ensure project requirements are met and deliverables are aligned with project timeline and quality expectations.
• Act as the lead statistical programmer for assigned device types or therapeutic areas, providing technical leadership by directing programming activities, coordinating multiple concurrent projects, monitoring project progress and deliverables, and mentoring junior programmers to promote programming excellence and adherence to industry standards and best practices.
• Review project documentation, including Statistical Analysis Plans (SAPs), mock TLF shells, programming specifications, CRFs, and database design specifications, providing proactive and strategic feedback to optimize programming efficiency, enhance data quality, and reduce rework and implementation risks.
• Drive innovation within the department by leading process improvement and operational efficiency initiatives, promoting best practices, standardization, and continuous improvement across statistical programming activities.

Knowledge, Skills and Abilities (KSA)

• Excellent written and verbal communication skills.
• Understanding of Statistical Analysis Plan (SAP) programming specifications.
• Knowledge of CDISC standards and requirements required.
• Strong attention to detail, accuracy, and initiative, with the ability to effectively manage multiple complex tasks simultaneously.

Qualifications/ Background Experiences

• Bachelor’s degree, preferably in a scientific, statistical, or related discipline, with a minimum of 5 years SAS programming experience in pharmaceutical, biotechnology, CRO, or medical device industry, or an equivalent combination of education, training and relevant experience.
• Extensive programming experience in SAS or other relevant software required, preferably within a clinical trial or regulated environment.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

www.terumoaortic.com