Early Development Statistician: Design & Analysis

Genentech; South San Francisco (CA); On-site; USD 121,000 - 224,000; Full time

Job summary

Genentech is seeking an Early Development Statistician to drive design and analysis for exploratory early clinical studies. You will apply statistical methods to guide go/no-go decisions, support protocol development, and contribute to regulatory submissions with robust, interpretable analyses.

The role emphasizes small-sample, exploratory objectives, PK/PD and early efficacy signals, while collaborating with cross-functional teams to accelerate timelines and maintain scientific rigor.

Qualifications

• MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field.
• Proficient in SAS and/or R; familiar with CDISC standards.
• Strong communication skills and ability to explain complex concepts clearly.

Responsibilities

• Contribute to protocol design, SAPs, and CRFs using established templates.
• Analyze data and support statistical analyses per SAPs with attention to small samples.
• Collaborate with study teams to meet accelerated timelines in early phase trials.
• Draft and review statistical reports and regulatory submissions (INDs, EMA, FDA).
• Apply rigorous statistical judgment to explore data and inform go/no-go decisions.
• Assist in mentoring peers and upholding quality within early phase methodology.

Skills

SAS

R

CDISC

Communication

Independent thinking

Education

MSc/PhD in Statistics/Biostatistics

Job description

Genentech is seeking an Early Development Statistician to drive design and analysis for exploratory early clinical studies. You will apply statistical methods to guide go/no-go decisions, support protocol development, and contribute to regulatory submissions with robust, interpretable analyses.

The role emphasizes small-sample, exploratory objectives, PK/PD and early efficacy signals, while collaborating with cross-functional teams to accelerate timelines and maintain scientific rigor.