Biostatistics Director – Oncology Biosimilars

This is a fully remote position, open to applicants in Illinois, +5 more states.

📋 Description

• Deliver strategic statistical insights for clinical development from early to late phases across various products and therapeutic areas.

• Establish and uphold statistical excellence in the design, analysis, and reporting of biosimilar development.

• Contribute to the formulation of clinical development plans.

• Assess clinical development plans, regulatory documents, study synopses, protocols, SAPs, flash memos, CSRs, submission documents, health-authority correspondence, and clinical publications.

• Recruit, allocate, manage, and enhance the skills of internal statistical personnel.

• Create and implement statistical strategies for clinical development programs.

• Ensure adherence to standards, technical quality, and uniform approaches in study design and statistical analysis.

• Offer statistical input into regulatory strategies, presentations, scientific reports, clinical trials, regulatory submissions, product defense, market support, and publications.

• Represent the statistical function in discussions with regulatory authorities, key opinion leaders, and specialized organizations.

• Provide oversight and mentorship to Amgen staff and CROs regarding study deliverables, timelines, and quality standards.

• Assist in the development and review of policies, SOPs, and controlled documents.

• Offer subject matter expertise in statistical methodologies.

• Publish applied research and present statistical methodologies at external scientific conferences.

• Remain updated on scientific advancements and revise internal practices accordingly.

• Cultivate and maintain relationships with statistical thought leaders in academia, regulatory agencies, and the industry.

⛳️ Requirements

• Doctorate degree and 4 years of Biostatistics experience OR Master’s degree and 8 years of Biostatistics experience OR Bachelor’s degree and 10 years of Biostatistics experience.

• Master’s or Doctorate degree in Mathematics, Biostatistics, or Statistics is preferred.

• A decade of post-graduate statistical experience in the pharmaceutical industry or medical research organizations.

• Profound knowledge of statistical methodologies and their applications in drug development, particularly in oncology.

• Familiarity with statistical methodologies and applications in drug development.

• Statistical leadership in regulatory submissions.

• Strong written and verbal communication and presentation skills, particularly in statistical strategy.

• Proven ability to drive innovation through the implementation of new methodologies and relevant statistical designs.

• Experience with adaptive designs, including group sequential design, treatment arm selection adaptations, Bayesian adaptive design, and/or combined phase 1/2 or phase 2/3 design.

• Comprehensive understanding of drug development life cycle from pre-clinical development through clinical development and post-marketing.

• Demonstrated leadership qualities and a history of developing high-performance teams.

• Experience collaborating within a global team and with CRO partners.

• Eligibility to work in the U.S., excluding Puerto Rico; sponsorship is not assured.

🏝️ Benefits

• A comprehensive employee benefits package, featuring a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off policies.

• Flexible work models where applicable.

• Opportunities for career development.

• Financial plans with options to save for retirement or other objectives.

• Support for work/life balance.