Biostatistician

Genentech • Daly City, CA

2d • $118,500 - $220,100 • Onsite

About The Position

This Biostatistician role is within Biostatistics, a core function of Product Development Data Science and Analytics (PDD) at Roche. Biostatistics provides strategic leadership and scientific rigor across Development, using data, digital, and design capabilities to support drug development decisions and clinical programs. The position is based onsite in South San Francisco.

As a key member of a cross-functional study or molecule team, the Statistician applies statistical expertise to the design, conduct, analysis, and interpretation of individual clinical trials. The role supports scientific rigor and regulatory compliance through contributions to protocol development, statistical analysis plans, data analyses, and interpretation and communication of results. The Statistician helps ensure each study generates robust, meaningful data to support decisions and regulatory submissions. The position works under guidance on trial design and study deliverables, applies established processes and templates, addresses moderately complex issues with appropriate judgment, and seeks guidance on novel or ambiguous situations. It also participates in peer review and mentoring relationships to uphold quality and develop methodological and regulatory expertise.

Requirements

• PhD in Statistics, Biostatistics, or a closely related quantitative field.
• 0–2 years of relevant experience in clinical trial statistics within a pharmaceutical, biotech, or CRO setting.
• Familiarity with ICH guidelines, GCP, and regulatory requirements such as FDA and EMA requirements.
• Strong understanding of statistical principles and methodology relevant to clinical trial design and analysis.
• Proficiency in SAS and/or R and familiarity with CDISC standards.
• Capacity for independent thinking and ability to make decisions based on sound principles.
• Excellent strategic agility, problem-solving, critical-thinking skills, and agility beyond the technical domain.
• Respect for cultural differences when interacting with colleagues in a global workplace.
• Excellent verbal and written communication skills, including presentation and writing, and ability to explain complex technical concepts clearly.

Nice To Haves

• Experience working in cross-functional teams.
• Ability to translate complex statistical concepts for non-statistical audiences.
• Experience with multiple phases of drug development, including early and/or late stage.
• Ability to influence and translate complex data for non-technical stakeholders.
• Strategic mindset and ability to contribute to portfolio-level decisions.

Responsibilities

• Contribute to trial design under guidance, applying standard statistical methods.
• Draft and review protocols, statistical analysis plans (SAPs), and case report forms (CRFs) using templates and precedents.
• Perform or support statistical analyses according to statistical analysis plans and escalate issues when needed.
• Represent Biostatistics and PDD at the Study Team level, ensuring statistical and scientific rigor of study deliverables under guidance.
• Collaborate with study team members to meet deliverables while following existing processes.
• Summarize findings clearly with support from senior colleagues.
• Contribute to clinical study report (CSR) development and regulatory responses using established templates.
• Apply judgment to moderately complex statistical or data issues, balancing scientific rigor with appropriate flexibility, and seek guidance on novel or ambiguous situations.
• Participate in peer review and mentoring relationships to uphold quality and build methodological and regulatory expertise.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for the benefits detailed at the link provided in the posting; specific benefits are not listed.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Ph.D. or professional degree