Biostatistician

Roche • South San Francisco, CA

2d • $118,500 - $220,100 • Onsite

About The Position

This role is within Biostatistics, a core function of Product Development Data Science and Analytics (PDD), which provides strategic leadership and scientific rigor across Development at Roche. Biostatistics applies data, digital, and design capabilities across PDD, PD, and the broader Roche Pharma organization to support scientifically rigorous decisions, robust clinical trials, regulatory success, and timely delivery of medicines to patients.

The Statistician is a key member of a cross-functional study or molecule team and applies statistical expertise to the design, conduct, analysis, and interpretation of individual clinical trials. The role supports scientific rigor and regulatory compliance by contributing to protocol development, drafting statistical analysis plans, performing or overseeing data analyses, and helping interpret and communicate results. The position is based on site in South San Francisco.

The role contributes to trial design under guidance using standard statistical methods; drafts and reviews protocols, statistical analysis plans, and case report forms using templates and precedents; and performs or supports analyses according to statistical analysis plans, escalating issues when needed. The Statistician represents Biostatistics and PDD at the Study Team level, collaborates with study team members to meet deliverables, summarizes findings with support from senior colleagues, contributes to clinical study report development and regulatory responses, and addresses moderately complex statistical or data issues while seeking guidance on novel or ambiguous situations. The role also participates in peer review and mentoring relationships to uphold quality and build 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 making decisions based on sound principles.
• Strong problem-solving and critical-thinking skills and strategic 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 the 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 clinical 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 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 benefits detailed at the provided link; specific benefits are not listed in the posting.

What This Job Offers

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