Head of Biostatistics, West Coast Hub

Role Summary

Head of Biostatistics, West Coast Hub leads the Biostatistics function across early and late clinical development for immune-mediated diseases. Responsible for strategic direction, scientific integrity, and regulatory submission support (NDA/BLA/MAA), while mentoring and aligning teams across locations.

Responsibilities

• Develop and oversee activities within the Biostatistics function for assigned therapeutic areas, ensuring high-quality and timely deliverables.
• Serve as a key member of the WCH Biometrics leadership team, contributing to the vision and goals of Biostatistics and the West Coast Hub Biometrics organization.
• Manage performance and career development of staff, fostering an engaging and collaborative culture.
• Enhance collaboration with other functional areas within Biometrics to drive innovations and overall productivity.
• Partner with West Coast Hub Statistical Programming and Data Management; establish relationships with Biostatistics and other quantitative science colleagues across Biogen.
• Engage with other R&D functions to set drug development strategies that increase success probability.
• Represent the company in biostatistical interactions with regulatory agencies, corporate partners, and CROs.
• Lead cross-functional initiatives representing Biometrics and participate in key R&D governance meetings.

Qualifications

• Required: PhD in Biostatistics/Statistics or equivalent with a minimum of 14 years relevant experience, or MS with a minimum of 16 years relevant experience.
• Broad understanding of statistical principles and clinical trial methodology.
• Experience in meeting FDA and international regulatory guidelines.
• Knowledge of medical/biological terminology and clinical practice in relevant therapeutic areas.
• Proven track record of staff development and effective people management.
• Strong ability to motivate and ensure productivity under ambiguous conditions.
• Leadership skills in proactive strategy setting, priority evaluation, and conflict resolution.

Skills

• Experience in cross-functional drug development strategies and governance.
• Ability to partner with clinicians, scientists and leadership from other functions.
• Ability to develop fit-for-purpose innovative statistical solutions across early and late-stage development; experience across multiple therapeutic areas.
• Filing experience in multiple global health authority jurisdictions.

Education

• PhD or MS in Biostatistics/Statistics or equivalent (as specified above).