Director, Biostatistics & Clinical Trial Strategy

Monte Rosa Therapeutics Inc.; Boston (MA); On-site; USD 150,000 - 200,000; Full time

Job summary

A biotechnology company in Boston is seeking a Director of Biostatistics to lead statistical strategy for Phase 1-3 clinical trials, primarily in oncology and inflammatory diseases. The candidate should have over 15 years of experience in clinical drug development, including expertise in regulatory standards and CRO management. Responsibilities include designing statistical methodologies, overseeing outsourced teams, and ensuring the quality of statistical deliverables. This role combines scientific leadership with hands-on execution.

Qualifications

• 15+ years of experience in clinical drug development, including Phase 1-3 trials.
• Strong expertise in statistics and regulatory standards.
• Experience with CRO management and oversight.

Responsibilities

• Lead statistical strategy for Phase 1-3 clinical studies.
• Oversee CROs, ensuring adherence to quality standards.
• Engage in regulatory submissions and response to health authority questions.
• Mentor statistical programmers and ensure compliance with standards.

Skills

Clinical trial statistics

SAS proficiency

Regulatory standards (FDA, ICH)

Statistical analysis

CRO management

Education

PhD in Biostatistics, Statistics, Mathematics, or related field

Job description

A biotechnology company in Boston is seeking a Director of Biostatistics to lead statistical strategy for Phase 1-3 clinical trials, primarily in oncology and inflammatory diseases. The candidate should have over 15 years of experience in clinical drug development, including expertise in regulatory standards and CRO management. Responsibilities include designing statistical methodologies, overseeing outsourced teams, and ensuring the quality of statistical deliverables. This role combines scientific leadership with hands-on execution.