Sr Director, Biostatistics (Oncology)

Location: Alameda, California, United States; onsite office-based role

Salary: $248,000–$352,500 annually, with additional bonus and long-term incentives eligibility.

Company

hirify.global develops oncology therapies and conducts clinical development programs supported by biostatistics, translational medicine, and biomarker research.

What you will do

• Lead statistical oversight and strategy for early development programs and phase 1/2 oncology clinical trials.
• Provide statistical input into study design, translational medicine, clinical biomarker strategy, protocols, statistical analysis plans, and case report forms.
• Develop and implement biostatistics department standards, policies, practices, and process-improvement initiatives.
• Recruit, develop, directly manage, and supervise biostatisticians and project statisticians.
• Provide regulatory and statistical guidance through interactions with FDA and EU authorities.
• Manage CROs and other vendors, including proposals, scopes of work, timelines, deliverables, budgets, and contract negotiations.

Requirements

• MS/MA in Statistics, Biostatistics, or a related discipline with at least 13 years of relevant experience, or a PhD with at least 12 years of relevant experience.
• At least 5 years managing oncology clinical trials and at least 10 years across other therapeutic areas.
• Experience leading phase 1 and phase 2 oncology studies and managing multiple statisticians.
• Experience analyzing clinical biomarker, genetics, and omics datasets.
• Comprehensive knowledge of statistical experimental design, clinical trial requirements, and FDA/EMA/ICH guidelines.
• Knowledge of CDISC standards, strong people-management and communication skills, and the ability to manage multiple projects under tight timelines.

Nice to have

• Direct experience interacting with FDA and/or EU authorities.
• Experience in oncology or an equivalent combination of education and relevant experience.

Culture & Benefits

• Collaborative office environment focused on sharing ideas and solutions.
• Dual monitors, ergonomic chairs, and necessary work equipment provided.
• 401(k) with company contributions, medical, dental, vision, life, disability, and flexible spending benefits.
• 15 vacation days in the first year, 17 paid holidays, a company-wide winter shutdown, and up to 10 sick days annually.
• Eligibility for discretionary annual bonuses, company stock purchase, and long-term incentives.