SENIOR BIOSTATISTICIAN

Sutro Biopharma•South San Francisco, CA

2d•$158,000 - $195,000•Onsite

About The Position

The Senior Biostatistician is an integral contributor within Sutro Biopharma’s Clinical Development organization. The role provides hands-on biostatistical support for clinical studies and contributes to statistical programming for analysis, data review, and decision-making. Working closely with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Clinical Pharmacology, Translational Sciences, and Regulatory Affairs, this person helps turn clinical and scientific questions into sound study designs and reliable, interpretable analyses. The role is primarily focused on biostatistics, with meaningful responsibility for writing, reviewing, and validating statistical programs. The Senior Biostatistician may serve as the study statistician for assigned trials, coordinate work with CRO partners, and remain directly engaged with emerging patient data.

Requirements

Master’s degree in Statistics, Biostatistics, or a related quantitative field with at least 5 years of relevant biopharmaceutical clinical trial experience; or a PhD with at least 3 years of relevant experience. Equivalent combinations of education and experience will be considered.
Experience providing independent statistical support for clinical studies, including protocol input, statistical analysis plans, analysis specifications, and interpretation of trial results.
Hands-on statistical programming experience in SAS and/or R, including analysis, visualization, and independent quality control of datasets or statistical outputs.
Working knowledge of clinical trial data structures and CDISC standards, including SDTM and ADaM, and experience reviewing tables, listings, and figures.
Ability to explain statistical concepts and data limitations clearly to clinical and scientific colleagues and manage several deliverables in a collaborative environment.

Nice To Haves

Early-phase oncology studies, including dose escalation, dose expansion, dose optimization, or exploratory biomarker analyses.
Experience with antibody-drug conjugates or other oncology therapeutics; exposure to small, clinical-stage biotechnology teams.
Experience coordinating or reviewing CRO statistical and programming work and supporting regulatory documents or health authority questions.

Responsibilities

Serve as the study biostatistician for assigned early-phase oncology trials, providing statistical input from protocol development through data review, analysis, interpretation, and clinical study reporting.
Contribute to study designs, endpoint definitions, analysis populations, sample size assumptions, dose-escalation and expansion approaches, and quantitative decision criteria; use simulations when useful.
Prepare or contribute to protocol statistical sections, statistical analysis plans, mock tables, listings and figures, analysis specifications, and clinical study report sections.
Analyze and interpret safety, efficacy, pharmacokinetic, pharmacodynamic, and biomarker data, accounting for the limitations of small and evolving datasets.
Support cohort reviews, dose optimization discussions, and ad hoc analyses that inform clinical and program decisions; communicate assumptions and uncertainty clearly to cross-functional teams.
Review clinical data and analysis outputs for quality, consistency, and scientific plausibility; identify issues that could affect interpretation and work with partners to resolve them.
Use SAS and/or R to conduct exploratory analyses, simulations, data checks, and visualizations; document code and results so analyses are reproducible.
Program or independently validate selected analysis datasets, tables, listings, figures, and patient-level displays, particularly for emerging data reviews and time-sensitive clinical questions.
Collaborate with statistical programmers and CROs on dataset specifications, analysis derivations, output shells, and quality control; review programmed deliverables against the statistical analysis plan and source data.
Apply working knowledge of CDISC SDTM and ADaM standards to understand data lineage, support analysis-ready datasets, and review submission-related outputs as assigned.
Provide technical direction and review for assigned CRO biostatistics and programming deliverables, tracking quality and timelines and escalating issues to the appropriate study or functional lead.
Partner with Clinical Development, Data Management, Clinical Operations, Clinical Pharmacology, Translational Sciences, and Drug Safety on data collection, interpretation, and presentation.
Contribute statistical analyses and documentation to clinical study reports, scientific presentations, manuscripts, regulatory submissions, and health authority responses as assigned.
Follow applicable GCP and ICH requirements, company procedures, and established standards for data integrity, code validation, documentation, and inspection readiness.
Help improve statistical and programming templates, workflows, and reproducible analysis practices; share technical knowledge with colleagues and external partners.