Genentech ยท 2 days ago
Statistician, Early Development
South San Francisco, CA
Full-time
Onsite
New Grad, Entry Level
$118K/yr - $194K/yr
0+ years expGenentech is a leading biotechnology company focused on developing innovative medicines. The Early Development Statistician plays a critical role in the design and analysis of exploratory clinical studies, applying statistical expertise to guide early-phase trial strategy, design, and interpretation.
BiotechnologyLife ScienceManufacturing
Responsibilities
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
Qualification
Required
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
Preferred
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
Benefits
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.
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
Chief Executive Officer
Michael Laird
Vice President
Recent News
2026-01-07
MarketScreener
2026-01-06
Company data provided by crunchbase