Senior Director, Safety Biostatistics (Oncology)

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

Salary: $270,000–$334,000 annually

Company

hirify.global is a public, clinical-stage precision medicine biotechnology company developing targeted oncology therapies, including synthetic lethality and antibody-drug conjugates, for molecularly defined solid tumors.

What you will do

• Lead Biometrics members within cross-functional oncology development teams.
• Provide strategic statistical input to clinical development plans, protocols, and study designs, with a focus on Drug Safety and Pharmacovigilance.
• Set statistical standards and methods for clinical and pharmacology datasets.
• Oversee, author, review, and approve protocols, SAPs, CRFs, IBs, DSURs, CSRs, publications, and related study documents.
• Manage internal and external biostatistics personnel, programmers, consultants, and vendors producing standardized statistical software and high-quality TFLs.
• Represent the biostatistics function with internal stakeholders, external vendors, key opinion leaders, and regulatory agencies.

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 performing interim and CSR analyses from Phase 1 through regulatory submission.
• Direct responsibility for multiple NDA/BLA submissions with approved oncology drugs.
• Expert knowledge of clinical trial design, statistical methodologies, safety analysis, and cross-functional leadership.

Culture & Benefits

• Collaborative, inclusive, data-driven environment focused on precision oncology and patient safety.
• Medical, dental, and vision coverage, with company-paid employee coverage and substantial dependent coverage.
• 401(k), ESPP, wellness programs, merit-based salary increases, short-term incentive eligibility, and discretionary stock option awards.
• Commitment to integrity, ethical conduct, equal employment opportunity, and reasonable accommodations.