Strategic Lead, Clinical Statistics & Submissions

Genentech; Boston (MA); Hybrid; USD 130,000 - 180,000; Full time

Job summary

A leading biotechnology company is seeking a Senior Principal Statistician based in Boston to apply their extensive statistical expertise in the design, conduct, analysis, and interpretation of clinical trials. The ideal candidate holds an MSc or PhD in Statistics and has a minimum of 12 years of experience in clinical development within the pharmaceutical sector. They will lead statistical strategy for molecule programs and mentor junior staff while ensuring regulatory compliance and scientific rigor across deliverables.

Qualifications

• Minimum of 12 years of experience in clinical development within the pharmaceutical, biotech, or healthcare sectors.
• Proven ability to lead statistical input into clinical development plans and regulatory submissions.
• Experience with innovative trial designs and clinical trial methodology.

Responsibilities

• Responsible for applying statistical expertise to the design, conduct, analysis, and interpretation of clinical trials.
• Accountable for delivering robust, meaningful data for decision-making and regulatory submissions.
• Mentor junior staff and promote quality standards.

Skills

Statistical expertise

SAS proficiency

R proficiency

Clinical trial methodology

Regulatory interactions

Problem-solving

Critical thinking

Education

MSc or PhD in Statistics, Biostatistics, or related field

Tools

SAS

R

Job description

A leading biotechnology company is seeking a Senior Principal Statistician based in Boston to apply their extensive statistical expertise in the design, conduct, analysis, and interpretation of clinical trials. The ideal candidate holds an MSc or PhD in Statistics and has a minimum of 12 years of experience in clinical development within the pharmaceutical sector. They will lead statistical strategy for molecule programs and mentor junior staff while ensuring regulatory compliance and scientific rigor across deliverables.