Head of Biostatistics, West Coast Hub

Role Summary

Head of Biostatistics, West Coast Hub at Biogen. Lead the Biostatistics function for a portfolio of immune-mediated diseases across early and late clinical development, oversee strategic directions, ensure scientific integrity, and drive regulatory submissions components. Provide mentorship and foster collaboration across teams and locations. Ideally based in the Bay Area with internal talent consideration for hybrid or remote arrangements.

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 in the broader Biogen organization.
• 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 work 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, e.g., indication selection, clinical development planning, go/no-go decision-making, strategic and technical governance review, late-stage execution.
• Ability to partner with clinicians, scientists and leadership from other functions (data-facing and otherwise).
• Ability to develop fit-for-purpose innovative statistical solutions to meet development program needs; deep early and late-stage development experience across multiple therapeutic areas.
• Filing experience in multiple global health authority jurisdictions.

Education

• PhD in Biostatistics/Statistics or equivalent, or MS in Biostatistics/Statistics with extensive relevant experience.