Senior Director, Safety Biostatistics (Oncology)

Location: South San Francisco, California, United States; onsite four days per week

Salary: $270,000–$334,000 per year

Company

hirify.global is a precision medicine oncology company developing targeted therapies for genetically defined solid tumors, including small-molecule and antibody-drug conjugate programs.

What you will do

• Lead Biometrics members within cross-functional clinical development teams.
• Provide strategic statistical input to clinical development plans, protocols, and oncology programs, with a focus on Drug Safety and Pharmacovigilance.
• Set statistical standards and methods for clinical and pharmacology datasets in collaboration with data management and other functions.
• Oversee, author, review, and approve protocols, SAPs, CRFs, IBs, DSURs, CSRs, publications, and related program documents.
• Manage internal and external biostatistics resources, consultants, vendors, programmers, and production of standardized statistical software and TFLs.
• Represent biostatistics in complex stakeholder discussions, regulatory interactions, and statistical defense of company positions.

Requirements

• Ph.D. or M.S. in Statistics or a closely related field.
• 15+ years of statistical experience in drug development, including 10+ years in oncology drug development.
• At least 8 years of extensive experience supporting Drug Safety and Pharmacovigilance in pharmaceutical R&D.
• Hands-on experience writing complex protocols and SAPs and conducting interim and CSR analyses from Phase 1 through regulatory submission.
• Direct responsibility for multiple NDA/BLA submissions with approved oncology drugs.
• Expertise in clinical trial design, statistical methodologies, safety analysis, cross-functional leadership, communication, and organization.

Culture & Benefits

• Collaborative, inclusive, data-driven environment focused on advancing precision oncology therapies.
• Medical, dental, and vision coverage, with 100% company-paid coverage for employees and 90% company-paid coverage for dependents.
• 401(k), employee stock purchase plan, wellness programs, and eligibility for merit increases, short-term incentives, and stock options.
• Work-from-home flexibility is available alongside required onsite work.
• Employees working in company facilities must be fully vaccinated, subject to applicable accommodations.