Biostatistician

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

The Position

Biostatistician

Department Summary

This role is within Biostatistics, a core function within Product Development Data Science and Analytics (PDD) that provides strategic leadership and scientific rigor across Development at Roche. Biostatistics identifies opportunities to apply the full breadth of data, digital, and design capabilities to deploy innovative methods across PDD, PD and the broader Roche Pharma organization.

As trusted analytical partners in end-to-end drug development, Biostatistics leverages data to drive scientifically rigorous programmatic decisions across Roche’s Development portfolio; Biostatistics designs robust trials and analysis plans that increase the probability of technical success, accelerating timelines to advance Roche’s clinical pipeline and promote regulatory success — ultimately bringing medicines to our patients faster.

This position is based in South San Francisco, on site.

The Opportunity

The Statistician is a key member of the cross-functional study or molecule team, responsible for applying statistical expertise to the design, conduct, analysis, and interpretation of individual clinical trials. This role ensures the scientific rigor and regulatory compliance of the study by contributing to protocol development, authoring statistical analysis plans, performing or overseeing data analyses, and supporting the interpretation and communication of results. The Statistician plays a critical role in ensuring that each study generates robust, meaningful data to support decision-making and regulatory submissions.

• You contribute to trial design under guidance, applying standard statistical methods.
• You draft and review protocols, statistical analysis plans (SAPs), and case report forms (CRFs) using templates and precedents.
• You perform or support statistical analyses as per statistical analysis plans, escalating issues when needed.
• You represent Biostatistics and PDD at the Study Team level, ensuring statistical and scientific rigor of study deliverables under guidance.
• You collaborate with study team members to meet deliverables, following existing processes.
• You summarize findings clearly with support from senior colleagues.
• You contribute to CSR development and regulatory responses using established templates.
• You apply judgment to address moderately complex statistical or data issues, balancing scientific rigor with appropriate flexibility, and seek guidance when facing novel or ambiguous situations.
• You adhere to functional standards by participating in peer review and mentoring relationships to uphold quality and build methodological and regulatory expertise.

Who You Are

• You hold a PhD in Statistics, Biostatistics, or a closely related quantitative field.
• You have 0-2 years of relevant experience in clinical trial statistics within a pharmaceutical, biotech, or CRO setting.
• You are familiar with ICH guidelines, GCP, and regulatory requirements (e.g., FDA, EMA).
• You have a strong understanding of statistical principles and methodology relevant to clinical trial design and analysis.
• You are proficient in SAS and/or R and familiar with CDISC standards.
• You demonstrate capacity for independent thinking and ability to make decisions based upon sound principles.
• You bring excellent strategic agility including problem-solving and critical thinking skills, and agility that extends beyond the technical domain.
• You demonstrate respect for cultural differences when interacting with colleagues in the global workplace.
• You have excellent verbal and written communication skills, specifically in the areas of presentation and writing, with the ability to explain complex technical concepts in clear language.

Preferred Qualifications

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

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $118,500.00 and $220,100.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.