Principal Statistician (Ophthalmology, Fully Remote)

Job summary

This role involves leading statistical activities within clinical trials, particularly in the field of ophthalmology, while working fully remotely. The Principal Statistician will mentor biostatisticians, oversee project timelines, and ensure high-quality statistical outputs throughout the project lifecycle.

Qualifications

• Graduate degree in biostatistics or a related field.
• Extensive experience in clinical trials or a combination of education and experience demonstrating the ability to manage multiple projects.
• Proficiency in R programming.

Responsibilities

• Serve as a resource for the statistical department, mentoring biostatisticians and developing training materials.
• Direct activities of biostatistics personnel on projects to ensure timely and quality work.
• Provide support for all statistical tasks from protocol to clinical study report (CSR).
• Prepare and oversee Statistical Analysis Plans (SAPs) and collaborate with sponsors as needed.
• Review programming specifications and ensure compliance with protocol criteria.
• Interface with project teams and contribute to internal meetings.
• Conduct quality control of project deliverables and manage multiple project timelines.
• Participate in Data Safety Monitoring Board (DSMB) activities as required.

Skills

• Strong knowledge of statistical design and analysis.
• Ability to apply relevant regulatory guidelines and programming standards.

Education

• Graduate degree in biostatistics or related discipline.

Tools

• Proficiency in R programming and familiarity with SAS.