Senior Statistician, Early Development

Overview The Early Development Statistician partners with Biostatistics, Analytical Data Science, and Data Management teams to design, analyze, and interpret exploratory clinical studies in early development at Roche. The role provides strategic leadership, scientific rigor, and high-quality statistical input to inform go/no‑go decisions and regulatory interactions across first‑in‑human, dose‑escalation, proof‑of‑concept, and biomarker‑enriched studies. Responsibilities Contribute to protocol design and statistical analysis plans (SAPs) for early phase studies. Lead the development and quality review of statistical deliverables, including protocols, SAPs, and CRFs. Design and execute complex analyses such as PK/PD modeling, exploratory biomarker data assessment, and interim futility evaluations. Identify data limitations or methodological challenges and propose solutions. Collaborate with study teams to align timelines, deliverables, and evolving scientific priorities. Interpret and communicate results within the clinical context, framing implications for dose/regimen selection, go/no‑go decisions, and future trial design. Lead statistical contributions to Clinical Study Reports (CSRs) and regulatory documents such as IND updates and briefing packages. Provide functional guidance and informal mentoring to less experienced statisticians. Who You Are • MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field.

• Minimum of 3years clinical trial statistics experience in pharmaceutical, biotech, or CRO settings.
• Demonstrated experience in design, analysis, and interpretation of cross‑phase studies, with solid understanding of regulatory expectations and statistical methodologies for clinical development.
• Proficiency in SAS and/or R, familiar with CDISC standards.
• Ability to work autonomously and collaborate effectively in cross‑functional teams.
• Strong strategic agility, problem‑solving, and critical‑thinking skills.
• Excellent verbal and written communication, capable of explaining complex technical concepts in clear language.
• Respect for cultural differences in a global workplace.

Preferred Experience supporting early‑stage drug development (PhaseI/II) with knowledge of FIH, SAD/MAD, dose‑finding, and proof‑of‑concept study designs. Proficiency with innovative statistical designs (adaptive trials, Bayesian frameworks, MIDD) and their application in early clinical research. Strong communication skills to translate exploratory or model‑based methodologies into actionable insights for clinicians and non‑statistical stakeholders. Mentoring or leadership experience guiding less experienced statisticians or cross‑functional partners in early‑phase strategy. Experience leading or influencing study‑level projects or cross‑study initiatives (e.g., platform protocols, disease‑area strategies). Compensation and Benefits Relocation benefits are not available for this posting. The expected salary range for the primary location (California) is \$136,900–\$254,200, determined based on experience, qualifications, geographic location, and other job‑related factors. 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. Genentech is an equal‑opportunity employer. The company’s policy prohibits unlawful discrimination, including discrimination on the basis of Protected Veteran status, individuals with disabilities status, and is 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 the Accommodations for Applicants form. #J-18808-Ljbffr F. Hoffmann-La Roche AG