Job Description

Job Title: Head of Biostatistics

Location: San Francisco, California (Hybrid Position)

Job Type: Full Time

Position Overview: The Head of Biostatistics will provide strategic and operational leadership for all biometrics activities, with a strong focus on oncology clinical development. This role is pivotal in driving statistical excellence, ensuring the integrity, accuracy, and regulatory compliance of clinical data and analyses across all phases of development. The ideal candidate will bring deep oncology expertise, heavy designing and org skills, and a proven ability to lead biostatistical strategy in a dynamic environment.

Key Responsibilities

• Develop and implement the strategic direction for the Biostatistics team
• Collaborate with cross-functional teams to support clinical development and regulatory submissions
• Provide biostatistical leadership across all phases (I-IV) of oncology clinical trials
• Ensure the quality and integrity of statistical deliverable, including protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs).
• Work directly with Reg Authorities

Qualifications:

• PhD in Biostatistics, Statistics, or a related field.
• 12+ years of experience within Oncology clinical trials (Early Oncology and Late Asset Experience)
• Proven track record of successful regulatory submissions and interactions (Strong BLA IND Filing Experience)
• Heavy Designing and Org skills
• Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment.
• Detail-oriented with strong problem-solving skills and the ability to manage multiple projects simultaneously.
• Ability to report on-site 4 days a week in South San Francisco, California (Relocation assistance is available)

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