SENIOR BIOSTATISTICIAN

Sutro Biopharma, Inc.; South San Francisco (CA); On-site; USD 158,000 - 195,000; Full time

Job summary

Sutro Biopharma, Inc. in South San Francisco, CA, is seeking a Senior Biostatistician to provide hands-on biostatistical support for early- and late-stage clinical studies and related programming.

You will design analyses, review results, and collaborate with cross-functional teams to inform decision-making. The role emphasizes writing and validating statistical programs, with potential to serve as study statistician, coordinate with CRO partners, and work with emerging patient data while

Qualifications

• Master’s degree in Statistics, Biostatistics, or a related quantitative field.
• Hands-on statistical programming experience in SAS and/or R.
• Experience providing independent statistical support for clinical studies.
• Familiarity with CDISC SDTM and ADaM standards.

Responsibilities

• Provide hands-on biostatistical support for clinical studies and contribute to statistical programming for analysis and decision-making.
• Serve as study statistician for assigned trials and coordinate work with CRO partners.
• Develop, review, and validate statistical programs and outputs in SAS and/or R.
• Ensure data integrity and quality across statistical analyses and reporting.
• Ensure adherence to GCP, ICH, and CDISC standards.

Skills

Biostatistics expertise

Clinical trial support

Statistical programming

Communication of statistics

Education

Master’s degree in Statistics/Biostatistics

PhD in a related quantitative field

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Senior Biostatistician

Position Summary:

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.

Key Responsibilities:

Biostatistics and Clinical Study Support

• 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.

Statistical Programming and Data Outputs

• 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.

Collaboration Quality and External Partners

• 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.

Qualifications:

• 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.

Preferred Experience:

• 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.

Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment.

As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.

The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $158,000 – $195,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.

About Sutro Biopharma

Sutro Biopharma, Inc., is relentlessly focused on the discovery and development of precisely designed cancer therapeutics to transform what science can do for patients. Sutro’s fit‑for‑purpose technology, including cell‑free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro is advancing a robust early‑stage pipeline of novel exatecan and dual‑payload antibody drug conjugates (ADCs), coupled with high‑value collaborations and industry partnerships, which validate its continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com.