Biostatistics Director, Nephrology Clinical Development

Biogen; San Francisco (CA); Hybrid; USD 209,000 - 288,000; Full time

Benefits offered by this job

Financial benefits package

Job summary

Biogen seeks a Director of Biostatistics, West Coast Hub, to provide statistical leadership for late-stage nephrology programs and oversee all biostatistics activities. You will shape analysis plans, contribute to regulatory submissions, and mentor statisticians across functions.

The ideal candidate holds a PhD in Biostatistics with 8+ years in pharma/biotech, strong FDA/EMA regulatory experience, and a proven ability to lead cross-functional teams in a fast-paced environment.

Qualifications

• PhD in Biostatistics/Statistics or equivalent.
• 8+ years relevant work experience in the pharmaceutical/biotech industry.
• Broad understanding of statistical principles and clinical trial methodology; able to practice and implement them.
• Knowledge of regulatory guidance (FDA and international).
• Knowledge of nephrology or immunology is preferred.

Responsibilities

• Develop and direct overall statistical activities for the assigned projects, ensuring high-quality and timely deliverables.
• Provide guidance and support for all biostatisticians on the projects through direct supervision, coaching and staff development.
• Represent biostatistics on project, study teams and governance meetings; provide guidance, oversight or input into strategy and regulatory submissions.
• Provide guidance and input addressing statistical issues in regulatory, legal, or other challenges, and represent the company in regulatory meetings and scientific conferences.
• Lead or participate in initiatives to identify opportunities for clinical development innovation and process improvement.
• Provide broader mentoring and leadership to ensure organizational missions and goals are achieved.

Skills

Pharma/biotech leadership

Statistical leadership

Regulatory knowledge (FDA/EMA)

Clinical trial design

Nephrology knowledge

Communication skills

Team management

Project strategy

Education

PhD in Biostatistics/Statistics

Job description

Biogen seeks a Director of Biostatistics, West Coast Hub, to provide statistical leadership for late-stage nephrology programs and oversee all biostatistics activities. You will shape analysis plans, contribute to regulatory submissions, and mentor statisticians across functions.

The ideal candidate holds a PhD in Biostatistics with 8+ years in pharma/biotech, strong FDA/EMA regulatory experience, and a proven ability to lead cross-functional teams in a fast-paced environment.