Biostatistics Director, Oncology Biosimilars- US Remote

Amgen•Thousand Oaks, CA

20h•Remote

About The Position

Amgen is seeking a Biostatistics Director to provide strategic statistical input and lead statistical aspects of clinical development, from early to late phase, for multiple products across therapeutic areas, with a focus on oncology biosimilars. The role develops and executes statistical strategies for clinical development programs, maintaining technical quality, consistent approaches, and indication-specific standards for study design, analysis, data structures, and presentation of results. The Director reviews product- and study-level development and regulatory materials, contributes to clinical development plans and regulatory strategies, and represents the statistical function in discussions with regulatory authorities, key opinion leaders, and specialist organizations. The position also leads and develops internal statistical staff, oversees work by Amgen staff and CRO partners, supports process improvements, and contributes statistical expertise and research to the broader scientific community. This is a U.S. remote position. Amgen describes its culture as collaborative, innovative, and science-based, and offers a competitive benefits and rewards package. The posted annual salary range is $200,108.70–$270,735.30, excluding Puerto Rico; actual compensation varies based on relevant skills, experience, and qualifications.

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.
Deep knowledge of statistical methodology and its applications in drug development.
Effective written and oral communication and presentation skills, including the ability to communicate statistical strategy.
Demonstrated ability to drive innovation through new methodologies and relevant statistical designs.
Demonstrated leadership attributes and a track record of charting direction and developing high-performance teams.

Nice To Haves

Master’s or doctorate degree in Mathematics, Biostatistics, or Statistics.
Ten years of post-graduate statistical experience in the pharmaceutical industry or medical research organizations, especially in oncology.
Experience in statistical methodologies for adaptive designs, such as group sequential designs, treatment-arm selection adaptations, or Bayesian adaptive designs, and/or combined phase 1/2 or phase 2/3 designs.
Statistical leadership for regulatory submissions.
Drug-development experience across the lifecycle, including pre-clinical development, clinical development, and post-marketing.
Experience working within a global team and with CRO partners to ensure operational excellence and efficiency.

Responsibilities

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