Senior Biostatistics Director: Biosimilars Strategy

Amgen; United States; Vor Ort; USD 230.000 - 300.000; Vollzeit

Zusammenfassung

Amgen seeks a Senior Director, Biostatistics to provide strategic statistical input and oversee biosimilar development for all products. You will lead and grow the biostatistics team, supervise CRO performance, and enhance statistical methods across development programs.

The role involves shaping regulatory submissions, science communications, and collaborations with authorities, academics, and industry partners to advance biosimilar programs.

Qualifikationen

• PhD or equivalent in statistics/biostatistics.
• Advanced degree required with significant leadership experience in biostatistics.
• Experience with regulatory submissions and CRO oversight is expected.

Aufgaben

• Provide strategic statistical input for biosimilar development across products.
• Lead and develop biosimilars biostatisticians and oversee CRO teams.
• Enhance statistical understanding within Biosimilar Development and propose innovative study designs.
• Contribute to regulatory strategies, presentations, and scientific reports.

Kenntnisse

Statistical leadership

Regulatory submissions

Team leadership

Communication skills

Ausbildung

Doctorate in Statistics/Biostatistics

Master’s in Statistics/Biostatistics

Bachelor’s in a related field

Jobbeschreibung

Amgen seeks a Senior Director, Biostatistics to provide strategic statistical input and oversee biosimilar development for all products. You will lead and grow the biostatistics team, supervise CRO performance, and enhance statistical methods across development programs.

The role involves shaping regulatory submissions, science communications, and collaborations with authorities, academics, and industry partners to advance biosimilar programs.