Software Engineer

• Develop, validate, and maintain statistical programs (SAS, R, or similar) for data manipulation, analysis, and reporting in clinical trials
• Collaborate with biostatisticians and clinical teams to understand project requirements and ensure accurate implementation of statistical analyses
• Prepare and review statistical analysis plans (SAPs) and programming specifications to meet regulatory standards
• Ensure data integrity and compliance with industry regulations, including ICH/GCP guidelines, throughout the programming process
• Participate in the preparation of clinical study reports and other documentation required by regulatory authorities
• Deliver statistical programming work to a high standard while working closely with team members and stakeholders

Software Engineer jobs in Japan

Statistical Programmer