Director of Biostatistics - Oncology
Location : San Francisco (Hybrid - 3 days onsite)
Compensation : $2100,000-$260,000 + Bonus + Equity
Company Summary :
We're working with a clinical-stage oncology biotech developing next-generation therapies for solid tumors and hematologic malignancies. With multiple assets in Phase 2 and a robust pipeline targeting high-unmet-need indications, the company is positioned to transform cancer care.
What sets this organization apart is its integration of advanced statistical modeling and real-world evidence to accelerate oncology drug development. Backed by leading investors and a leadership team with multiple oncology approvals, the company is expanding its biometrics function and seeking a Director of Biostatistics to lead statistical strategy across all oncology programs.
Primary Responsibilities :
- Lead statistical strategy for oncology clinical trials from early development through registration.
- Design innovative oncology trial methodologies, including adaptive and basket / umbrella designs.
- Provide statistical leadership for protocol development, SAPs, and data interpretation to support critical go / no-go decisions.
- Represent biostatistics in regulatory submissions and interactions with FDA, EMA, and other health authorities.
- Oversee internal biostatistics teams and manage CRO partnerships to ensure quality and compliance.
- Collaborate with Clinical Development, Medical Affairs, and Data Science to drive data-driven oncology strategies.
Ideal Qualifications :
PhD or MS in Biostatistics, Statistics, or related quantitative discipline.8+ years of biostatistics experience in oncology drug development, with at least 3 years in a leadership role.Proven track record in regulatory submissions and successful oncology product approvals.Expertise in CDISC standards (SDTM, ADaM)Oncology experience in industry