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Director of Biostatistics
Director of BiostatisticsEPM Scientific • San Francisco County, CA, United States
Director of Biostatistics

Director of Biostatistics

EPM Scientific • San Francisco County, CA, United States
21 days ago
Job type
  • Full-time
Job description

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
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