Senior Director, Biostatistics — Biosimilars Leadership

Initial Therapeutics, Inc.; Washington (District of Columbia); On-site; USD 210,000 - 320,000; Full time

Job summary

Amgen is seeking a Senior Director, Biostatistics to provide strategic statistical input and lead a team of biosimilars biostatisticians. You will oversee CROs, enhance statistical methods, and shape regulatory strategies across biosimilar programs.

You will manage staff, collaborate with leaders, and contribute to trial design, analysis plans, and regulatory submissions, helping to advance medicines for patients worldwide.

Qualifications

• Doctorate degree and 5 years of Senior Director, Biostatistics experience
• OR Masters degree and 9 years of Senior Director, Biostatistics experience
• OR Bachelors degree and 11 years of Senior Director, Biostatistics experience
• At least 5 years experience directly managing people and/or leadership experience

Responsibilities

• Provide oversight for protocols, SAPs, flash memos, study reports and regulatory communications.
• Develops and maintains statistical excellence in design, analysis and reporting for biosimilar development.
• Ensures standards, quality and consistency in clinical development strategy and statistics.
• Provides statistical input into regulatory strategies and submissions for regulatory authorities.
• Oversees staff and CROs to deliver study deliverables on time and to quality standards.
• Responsible for hiring, allocation and development of statistical staff and budgets.
• Leads development and review of Policies and SOPs with CROs and Amgen Biosimilar Development.
• Publishes applied research and shares statistical methodology at scientific meetings.

Skills

Leadership

Biostatistics

Regulatory submissions

Data analysis

Education

Doctorate in Statistics/Biostatistics

Masters degree

Bachelors degree

Job description

Amgen is seeking a Senior Director, Biostatistics to provide strategic statistical input and lead a team of biosimilars biostatisticians. You will oversee CROs, enhance statistical methods, and shape regulatory strategies across biosimilar programs.

You will manage staff, collaborate with leaders, and contribute to trial design, analysis plans, and regulatory submissions, helping to advance medicines for patients worldwide.