Senior Biostatistics Director (Oncology)

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

Salary: $216,500–$307,500 annually, depending on geographic market, experience, skills, and internal equity.

Company

hirify.global is a biotechnology and pharmaceutical company developing clinical programs and therapies, including in oncology.

What you will do

• Lead statistical strategy, design, conduct, and analysis for Phase I–IV clinical trials, particularly oncology studies.
• Review trial protocols, case report forms, and statistical analysis plans for methodological soundness.
• Analyze and interpret study results and collaborate with clinical teams on interim reports, final reports, and publications.
• Direct the development, validation, and reporting of integrated safety and efficacy summaries.
• Represent biostatistics in interactions with FDA, EU authorities, institutional review boards, ethics committees, and health agencies.
• Manage contract research organizations and vendors, including proposals, scope of work, timelines, deliverables, budgets, and contract negotiations.

Requirements

• BS/BA with at least 15 years of related experience, MS/MA with at least 13 years, or PhD with at least 12 years in Statistics, Biostatistics, or a related discipline.
• Extensive experience managing or supporting clinical trials and statistical analysis of Phase I–IV studies for US NDAs.
• Comprehensive knowledge of experimental design, clinical trial requirements, oncology statistics, and FDA/EU statistical guidelines.
• Experience developing or reviewing SDTM and ADaM specifications and applying CDISC standards.
• Advanced experience with statistical software such as SAS, EAST, nQuery, and Cytel Studio.
• Strong analytical, business communication, project management, and vendor negotiation skills.

Nice to have

• Experience in the oncology therapeutic area and biotech or pharmaceutical industry.
• Leadership of a Phase III clinical trial.
• Direct experience working with FDA or EU authorities.

Culture & Benefits

• Collaborative office environment focused on sharing ideas and solutions.
• Comprehensive medical, dental, and vision coverage, plus life and disability insurance.
• 401(k) plan with company contributions and flexible spending accounts.
• Annual discretionary bonus, company stock purchase opportunities, and long-term incentives.
• 15 accrued vacation days in the first year, 17 paid holidays including a company-wide winter shutdown, and up to 10 sick days annually.
• Office equipment including dual monitors and ergonomic chairs.