TL;DR

Statistician Early Development (Data Science/ML): Designing and analyzing exploratory early-phase clinical trials with an accent on statistical rigor, adaptive methods, and regulatory interactions. Focus on developing statistical analysis plans, interpreting complex data, and supporting early go/no-go decisions in a fast-paced pharmaceutical environment.

Location: South San Francisco, California, United States

Salary: $118,500–$194,000 per year

Company

%hirify_global% is a pioneering biotechnology company dedicated to groundbreaking science and developing medicines for serious diseases, part of the Roche group.

What you will do

Contribute to early phase clinical trial design using standard and adaptive statistical methods.
Draft and review protocols, statistical analysis plans (SAPs), and case report forms (CRFs) aligned with early development goals.
Perform or support statistical analyses of complex and high-dimensional data, flagging anomalies and design challenges.
Collaborate with cross-functional study teams to meet accelerated timelines and evolving processes.
Summarize findings clearly to inform early go/no-go decisions and subsequent phase designs.
Support clinical study reports and regulatory submissions for FDA and EMA interactions.

Requirements

Location: Must be based in South San Francisco, California, United States
MSc or PhD in Statistics, Biostatistics, or related quantitative field.
0 to 2 years of relevant clinical trial statistics experience in pharmaceutical, biotech, or CRO settings.
Familiarity with ICH guidelines, GCP, FDA and EMA regulatory requirements.
Proficiency in SAS and/or R; familiarity with CDISC standards.
Strong statistical principles and methodologies relevant to clinical trial design and analysis.
Excellent verbal and written communication skills in English.

Nice to have

Experience working in global cross-functional study teams.
Understanding of early-phase drug development phases and innovative design methods like Bayesian approaches.
Experience in matrixed early development environments and fast-paced settings.
Ability to communicate complex statistical concepts to non-statistical audiences.

Culture & Benefits

Equal opportunity employer with a commitment to diversity and inclusion.
Comprehensive benefits package as detailed by the company.
Supportive environment for professional growth and mentorship.