Early-Phase Statistician for Drug Development

F. Hoffmann-La Roche AG; South San Francisco (CA); On-site; USD 121,000 - 224,000; Full time

Job summary

Genentech, a member of the Roche group, is seeking an Early Development Statistician to design and analyze exploratory clinical studies, guiding early-phase trial strategy and interpretation.

You will collaborate with Biostatistics, Analytical Data Science, and Data Management to implement rigorous statistical methods, adaptivity, and model-based approaches, supporting regulatory interactions and decision milestones.

Qualifications

• MSc or PhD in Statistics or Biostatistics.
• 0 to 2+ years in clinical trial statistics.
• Familiar with ICH, GCP, and FDA/EMA regulatory expectations.
• Proficient in SAS and/or R; CDISC standards familiarity.

Responsibilities

• Contribute to protocol design, SAPs, and CRFs using established templates.
• Analyze high‑dimensional data to inform early go/no‑go decisions.
• Help shape early phase trial design with adaptive methods.
• Interpret outputs and translate into concise insights for decisions.
• Support clinical study reports and regulatory submissions.

Skills

SAS

R

Statistical methods

Clinical trial design

Communication skills

Education

MSc or PhD in Statistics/Biostatistics

Tools

CDISC standards

Job description

Genentech, a member of the Roche group, is seeking an Early Development Statistician to design and analyze exploratory clinical studies, guiding early-phase trial strategy and interpretation.

You will collaborate with Biostatistics, Analytical Data Science, and Data Management to implement rigorous statistical methods, adaptivity, and model-based approaches, supporting regulatory interactions and decision milestones.