Senior Director, Safety Biostatistics (Oncology)

Location: South San Francisco, California, United States; onsite four days per week, with some work-from-home flexibility.

Salary: $270,000–$334,000 per year.

Company

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

What you will do

• Lead Biometrics members within cross-functional clinical development teams.
• Provide strategic statistical input on clinical development plans, protocols, and oncology programs in collaboration with Drug Safety, Pharmacovigilance, Clinical Sciences, Clinical Pharmacology, Regulatory, Commercial, and Data Management functions.
• Set statistical standards and methods for clinical and pharmacology datasets.
• Oversee, author, review, and approve protocols, SAPs, CRFs, IBs, DSURs, CSRs, publications, and other study and program documents.
• Manage internal and external biostatistical personnel, programmers, consultants, and vendors to deliver standardized statistical software and high-quality tables, figures, and listings.
• Represent the biostatistics function, resolve complex stakeholder concerns, mentor development teams, and maintain current statistical and regulatory practices.

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.
• 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 methodology, safety analysis, cross-functional leadership, communication, writing, and organization.

Culture & Benefits

• Collaborative, inclusive, and data-driven environment focused on precision oncology and improving outcomes for cancer patients.
• Competitive total rewards with merit-based salary increases, discretionary short-term incentives, and potential stock option awards.
• Medical, dental, and vision coverage, with the company paying 100% for employees and 90% for dependents.
• 401(k), ESPP, and wellness programs.
• Employees working in company facilities must be fully vaccinated against COVID-19, subject to applicable accommodations and legal requirements.