Statistician, Early Development

Genentech • Daly City, CA

7d

About The Position

The Early Development Statistician is a critical partner in the design and analysis of exploratory clinical studies, applying statistical expertise to guide early-phase trial strategy, design, and interpretation. This role ensures scientific rigor while maintaining the flexibility needed for hypothesis generation and signal detection. Responsibilities include contributing to protocol design, developing statistical analysis plans, and analyzing complex, often high-dimensional data to inform early go/no-go decisions and regulatory interactions. The Statistician helps shape the early clinical narrative by ensuring data are robust, interpretable, and aligned with the evolving development strategy.
You contribute to early phase trial design under guidance, leveraging standard and adaptive methods for small samples and exploratory objectives, for example dose escalation models and Bayesian approaches.
You draft and review protocols, SAPs, and CRFs using established templates and examples, ensuring alignment with early development goals such as pharmacokinetics, pharmacodynamics, and early efficacy signals.
You perform or support statistical analyses per SAPs, often with non traditional endpoints or biomarkers, and proactively flag data anomalies or design related challenges given smaller datasets and less mature endpoints.
You collaborate with study teams to meet deliverables on accelerated timelines, adhering to evolving processes common in early phase trials.
You summarize findings clearly with support, translating complex outputs into concise insights that inform early go no go decisions or subsequent phase designs.
You contribute to clinical study reports and regulatory submissions, supporting documentation for INDs, EMA scientific advice, and FDA pre IND meetings, using appropriate templates.
You apply judgment to solve moderately complex statistical or data issues, balancing rigor with the flexibility needed in early phase development, and seek guidance when facing novel or ambiguous situations.
You adhere to functional standards and participate in peer review and mentoring to uphold quality while building expertise in early phase methodology and regulatory expectations.
You work under general supervision and apply independent judgment to interpret guidance, prioritize responsibilities, and make decisions in situations that require contextual understanding.

Requirements

• You hold an MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field.
• You bring 0 to 2 years of relevant experience in clinical trial statistics in pharmaceutical, biotech, or CRO settings.
• You are familiar with ICH guidelines, GCP, and regulatory requirements such as FDA and EMA.
• You have a strong understanding of statistical principles and methodologies relevant to clinical trial design and analysis
• You are proficient in SAS and or R and familiar with CDISC standards
• You demonstrate independent thinking and make decisions based on sound principles.
• You demonstrate excellent strategic agility including problem solving and critical thinking, with 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 in presentation and writing, with the ability to explain complex technical concepts in clear language.

Nice To Haves

• Experience working in cross-functional global study teams, including Clinical Pharmacology, Translational Medicine, and Early Clinical Development.
• Effective communication skills with the ability to translate complex, often exploratory or model-based statistical concepts for non-statistical audiences, including clinicians and early decision-makers.
• Basic understanding of the multiple phases of drug development, with a strong emphasis on early-phase (Phase I/II) design and analysis, including first-in-human, SAD/MAD, and proof-of-concept studies.
• Experience within a matrixed early development environment, including providing statistical guidance in fast-paced, high-uncertainty settings.
• Familiarity with innovative design methods (e.g., Bayesian designs, model-informed drug development) and regulatory expectations for exploratory endpoints.
• Agility and comfort working with incomplete or evolving data and pivoting approaches based on emerging results in early clinical trials.

Responsibilities

• Contribute to early phase trial design under guidance, leveraging standard and adaptive methods for small samples and exploratory objectives, for example dose escalation models and Bayesian approaches.
• Draft and review protocols, SAPs, and CRFs using established templates and examples, ensuring alignment with early development goals such as pharmacokinetics, pharmacodynamics, and early efficacy signals.
• Perform or support statistical analyses per SAPs, often with non traditional endpoints or biomarkers, and proactively flag data anomalies or design related challenges given smaller datasets and less mature endpoints.
• Collaborate with study teams to meet deliverables on accelerated timelines, adhering to evolving processes common in early phase trials.
• Summarize findings clearly with support, translating complex outputs into concise insights that inform early go no go decisions or subsequent phase designs.
• Contribute to clinical study reports and regulatory submissions, supporting documentation for INDs, EMA scientific advice, and FDA pre IND meetings, using appropriate templates.
• Apply judgment to solve moderately complex statistical or data issues, balancing rigor with the flexibility needed in early phase development, and seek guidance when facing novel or ambiguous situations.
• Adhere to functional standards and participate in peer review and mentoring to uphold quality while building expertise in early phase methodology and regulatory expectations.
• Work under general supervision and apply independent judgment to interpret guidance, prioritize responsibilities, and make decisions in situations that require contextual understanding.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees