Biostatistics Director, Oncology Biosimilars- US Remote

Amgen • Baltimore, MD

1d • $200,109 - $270,735 • Remote

About The Position

The Biostatistics Director provides strategic statistical input and is responsible for statistical aspects of clinical development from early to late phase for multiple products across therapeutic areas, with a focus on oncology biosimilars. The role leads statistical strategy and supports clinical development plans, study design, analysis, reporting, regulatory submissions, and product defense. It also includes hiring, managing, and developing statistical staff; overseeing internal and CRO deliverables; contributing to policies and process improvements; and representing the statistical function with regulatory authorities, scientific bodies, and external experts.

Requirements

• Doctorate degree and 4 years of Biostatistics experience, or a master’s degree and 8 years of Biostatistics experience, or a bachelor’s degree and 10 years of Biostatistics experience.
• Ten years of post-graduate statistical experience in the pharmaceutical industry or medical research organizations, with deep knowledge of statistical methodology and applications in drug development, especially oncology.
• Knowledge of statistical methodology and applications within drug development.
• Statistical leadership for regulatory submissions.
• Effective written and oral communication and presentation skills, including communicating statistical strategy.
• Demonstrated ability to drive innovation by implementing new methodologies and relevant statistical designs.
• Experience with adaptive-design methodologies, such as group sequential designs, treatment-arm selection adaptations, or Bayesian adaptive designs, and/or combined phase 1/2 or phase 2/3 designs.
• Drug development life-cycle experience, including pre-clinical development, clinical development, and post-marketing.
• Demonstrated leadership and a track record of charting direction and developing high-performance teams.
• Experience working in global teams and with CRO partners to ensure operational excellence and efficiencies.

Nice To Haves

• Master’s or doctorate degree in Mathematics, Biostatistics, or Statistics.

Responsibilities

• Develop and maintain statistical excellence in design, analysis, and reporting throughout biosimilar development across products and therapeutic areas.
• Provide strategic statistical input and contribute to clinical development plans.
• Review product- and study-level documents, including development plans, regulatory documents, synopses, protocols, statistical analysis plans, flash memos, clinical study reports, submission documents, health authority correspondence, and publications.
• Hire, allocate, manage, and develop internal statistical staff, and contribute to goals, budgets, and resource plans.
• Develop and execute statistical strategies for clinical development programs, ensuring standards, technical quality, and consistent approaches while maintaining indication-specific standards.
• Provide statistical input into regulatory strategies, presentations, and scientific reports for clinical trials, submissions, product defense, market support, and publications.
• Represent the statistical function in meetings with regulatory authorities, key opinion leaders, and specialist bodies, and defend statistical approaches.
• Provide oversight and mentorship to Amgen staff and CROs to ensure study deliverables meet timelines and quality standards.
• Support development and review of policies, SOPs, and other controlled documents to improve processes and operational efficiency.
• Provide expertise in statistical methodologies, publish applied research, and present statistical methodology at external scientific meetings.
• Stay current with scientific advances and contribute to the field, ensuring internal practices remain current.
• Develop and maintain long-term relationships with statistical opinion leaders in academia, regulatory agencies, and industry.

Benefits

• Retirement and Savings Plan with company contributions
• Medical, dental, and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible
• Career development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Director