Senior Director, Biostatistics

Summary

Join Annexon Biosciences as their Senior Director, Biostatistics, a leadership role overseeing a team of statisticians responsible for clinical development, submission strategy, and clinical trial analysis. This highly visible and collaborative position involves partnering with clinical and regulatory experts to advance medicines. You will establish the vision for Biostatistics, lead project statisticians, serve as a methodological expert, and ensure scientifically sound development strategies. The role also includes representing Annexon at regulatory meetings and contributing to a positive team culture. This position reports to the SVP, Biometrics and offers a competitive salary and benefits package.

Requirements

• PhD in statistics or related field with 10+ years (or MS with 15+ years) of experience in the pharmaceutical or biotechnology industry
• Experience leading product development programs through submission and approval
• Demonstrated expertise in advanced statistical methods (e.g. Adaptive designs, Bayesian methods, real world evidence, multiplicity, subgroup identification, precision medicine, modeling & simulation etc.)
• Deep understanding of Regulatory guidelines (FDA/EMA/ICH) and the submission and approval process, with the ability to interpret and apply them in real-time drug development settings

Responsibilities

• Establish the vision for Biostatistics by building and maintaining a high performing organization that serves as a key strategic partner within Annexon
• Lead and oversee project level statisticians, providing operational, strategic, and technical guidance while ensuring accountability for all statistical deliverables, including, development plans, protocols, SAPs, analyses, reports, and regulatory submissions within Annexon
• Serve as methodological expert providing guidance to statisticians, teams and executive leadership
• Ensure scientifically sound development strategies that incorporate both current best practices and innovative approaches. Propose and implement optimal methodologies including accelerated, Bayesian or seamless designs
• Represent Annexon at key regulatory meetings and/or FDA advisory committee meetings or deploy qualified staff as appropriate
• Serve on the Biometrics leadership team to provide guidance on direction and operations of the department
• Define, advance and codify the department’s procedural framework including the operating model, process definitions, SOPs, and best practices
• Collaborate cross-functionally with key partners to drive the advancement of Annexon products, contributing to data acquisition, study quality activities, regulatory reporting and communications, publication planning and support and data interpretation
• Ensure appropriate oversight of Biometrics outsourced activities
• Contribute to and participate in the development and maintenance of a positive team-focused company culture

Preferred Qualifications

• Experience building and leading high performing teams; and identifying, attracting, developing, and retaining top talent
• Ability to communicate with clarity and influence executives, regulators, and key stakeholders, including translating complex quantitative issues in simple, understandable terms
• Experience with clinical trial outsourcing models and associated GCP oversight
• Leadership acumen including emotional intelligence and business awareness
• Strong ability to collaborate and influence at all levels of the organization, coupled with excellent judgement in negotiation – balancing compromise, standing firm, or identifying alternative solutions
• Strategic and innovative approach to drug-development, with a willingness to challenge the status quo
• Ability to balance appropriate levels of structure/process with efficiency and simplicity
• Awareness of external industry landscape with respect to best practices and emerging topics

Benefits

• Flexible work schedules
• Remote opportunities
• Ability to achieve a work-life balance
• Shuttle service from BART, CalTrain and the Ferry
• Competitive base salary and equity participation
• Employee stock purchase plan
• Comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits