Biostatistics Director, Oncology Biosimilars- US Remote

Key Responsibilities

• Develops and maintains successful application of statistical excellence in design, analysis, and reporting to all phases of biosimilar development across multiple products and therapeutic areas.
• Provides strategic statistical input and is a major contributor to clinical development plans.
• Reviews product and study level documents such as clinical development plans, regulatory documents, study synopses, protocols, statistical analysis plans (SAPs), flash memos, clinical study reports (CSRs), submission documents, correspondences with health authorities, and clinical publications.
• Responsible for hiring, allocation, management, and development of internal statistical staff, and contributes to developing and managing goals, budgets and resource plans.
• Developing and execution of statistical strategy for clinical development programs ensuring standards, technical quality and consistent approaches in clinical development strategy, study design and statistical analysis while maintaining indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results.
• Ensuring excellent statistical input into regulatory strategies, presentations and scientific reports for clinical trial, regulatory submission, product defense, market support, scientific presentations/publications.
• Representing the statistical function at meetings with regulatory authorities, key opinion leaders and other specialist bodies and defending statistical approaches.
• Providing oversight and mentorship to Amgen staff members and CROs in completing study deliverables per agreed to timelines and quality standards.
• Supporting the development and review of Policies, SOPs and other controlled documents with CROs or within Amgen for process improvement and operational efficiency.
• Providing subject matter expertise in statistical methodologies, publishing applied research in scientific journals and books and making presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings.
• Staying abreast of and contributing to scientific advances in the field and ensuring internal practices are current.
• Developing and maintaining long-term relationships with key statistical opinion leaders within academics, regulatory agencies and industry.

Basic Qualifications

• 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

Preferred Qualifications

• Master's or Doctorate degree in Mathematics, Biostatistics or Statistics
• Ten years post-graduate statistical experience in the pharmaceutical industry or medical research organizations with a deep knowledge of statistical methodology and applications within drug development, especially in the oncology therapeutic area.
• Knowledgeable of statistical methodology and applications within drug development
• Statistical leadership to regulatory submissions
• Effective communication and presentation skills including statistical strategy
• Demonstrated ability to drive innovation by implementing new methodologies and relevant statistical designs.
• Experience in statistical methodologies related to adaptive designs (e.g., group sequential design, adaptations to treatment arm selection design, Bayesian adaptive design) and/or combined phase 1/2 or phase 2/3 design.
• Statistical leadership for regulatory submissions.
• Demonstrated effective communication and presentation skills including statistical strategy (written and oral).
• Life cycle Drug development experience (pre-clinical development, clinical development, post-marketing).
• Demonstrated leadership attributes with a track record in charting the course and developing high-performance teams.
• Background in working within a global team and with CRO partners to ensure operational excellence and efficiencies.