Senior Director, Biostatistics

Job Title: Senior Director, Biostatistics

Location:San Franciso, California (Hybrid Position)

Job Type: Full Time

Reports to: VP Biometrics

Position Overview: The Senior Director, 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, strong cross-functional collaboration skills, and a proven ability to lead biostatistical strategy in a dynamic environment.

Key Responsibilities

• Develop and implement the strategic direction for the Biometrics 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).
• Stay current with industry trends and advancements in biostatistics and clinical trial methodologies.

Qualifications:

• PhD in Biostatistics, Statistics, or a related field.
• At least 15 years of experience in the biotechnology or pharmaceutical industry.
• 10 years of experience within Oncology clinical trials
• Proven track record of successful regulatory submissions and interactions.
• 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.