Lead Statistical Programmer - Clinical Trials & Submissions

Terumo Aortic; United States; On-site; USD 87,000 - 122,000; Full time

Job summary

Terumo Aortic is seeking a Senior Statistical Programmer to develop, validate, and document statistical analysis programs for clinical trial data and regulatory submissions. The role leads programming activities, ensures quality and regulatory compliance, and mentors junior programmers across cross-functional teams.

You will drive quality checks, coordinate multiple projects, review SAPs and databases, and push process improvements to enhance efficiency and data integrity.

Qualifications

• Bachelor’s degree in a scientific, statistical, or related discipline.
• Minimum of 5 years SAS programming experience in pharmaceutical, biotechnology, CRO, or medical device industry.
• Extensive programming experience in SAS or other relevant software in regulated environments.
• Knowledge of CDISC standards and requirements.

Responsibilities

• Develop, validate, document, and troubleshoot statistical programs for clinical trial datasets (SDTM/ADaM) and outputs.
• Perform quality control checks and peer code reviews for regulatory submissions and publications.
• Collaborate with biostatisticians, data managers, and cross-functional teams to meet project requirements.
• Lead programming activities for assigned device types or therapeutic areas and mentor junior programmers.
• Review SAPs, CRFs, and database design specs to optimize programming efficiency and data quality.

Skills

Communication skills

SAP programming

CDISC standards

Attention to detail

Education

Bachelor’s degree in a scientific或 related discipline

Tools

SAS

Job description

Terumo Aortic is seeking a Senior Statistical Programmer to develop, validate, and document statistical analysis programs for clinical trial data and regulatory submissions. The role leads programming activities, ensures quality and regulatory compliance, and mentors junior programmers across cross-functional teams.

You will drive quality checks, coordinate multiple projects, review SAPs and databases, and push process improvements to enhance efficiency and data integrity.