Clinical Biostatistician – Trials & Regulatory Analytics

Genentech, Inc.; South San Francisco (CA); On-site; USD 119,000 - 220,000; Full time

Job summary

Genentech, Inc. in South San Francisco, CA, is seeking a Biostatistician to contribute statistical expertise across the design, conduct, and analysis of clinical trials. This role emphasizes regulatory-ready analysis plans and robust data interpretation.

You will draft SAPs, analyze data, and support CSR development, collaborating with cross-functional teams to ensure high-quality deliverables for decision-making and regulatory submissions.

Qualifications

• PhD in Statistics, Biostatistics, or a closely related field.
• 0–2 years of relevant experience in clinical trial statistics.
• Familiar with ICH guidelines, GCP, and regulatory requirements (FDA/EMA).
• Proficient in SAS and/or R; familiar with CDISC standards.

Responsibilities

• Design, conduct, analysis, and interpretation of clinical trials under guidance.
• Draft and review SAPs, CRFs, and related study documents.
• Collaborate with cross-functional teams to ensure regulatory-ready analyses.
• Contribute to CSR development and regulatory responses using standard templates.
• Summarize findings clearly and support decision-making with robust data.

Skills

Statistical principles

Clinical trial statistics

Education

PhD in Statistics/Biostatistics

Tools

SAS

R

CDISC

Job description

Genentech, Inc. in South San Francisco, CA, is seeking a Biostatistician to contribute statistical expertise across the design, conduct, and analysis of clinical trials. This role emphasizes regulatory-ready analysis plans and robust data interpretation.

You will draft SAPs, analyze data, and support CSR development, collaborating with cross-functional teams to ensure high-quality deliverables for decision-making and regulatory submissions.