Senior Director, Biostatistics

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Requirements:

• Doctorate degree and 5 years of related experience of post-graduate statistical experience in the pharmaceutical industry or medical research OR Master’s degree and 9 years of related experience of post-graduate statistical experience in the pharmaceutical industry or medical research OR Bachelor’s degree and 11 years of related experience of post-graduate statistical experience in the pharmaceutical industry or medical research
• 5 years of experience directly managing people and/or leading teams, projects, or programs, in Statistics/Biostatistics
• statistical leadership to regulatory submissions, including advisory committees
• Demonstrated ability to work within a global team and with CRO partners to ensure operational excellence and efficiencies
• Life cycle Drug development experience (Pre-clinical Development, Clinical Development, and Post-marketing), hence knowledgeable of the processes and operations
• Knowledge/experience of Biosimilars development, including global regulatory requirements and design and analysis of non-inferiority and equivalence trials

Responsibilities:

• Provide oversight for protocols, Statistical Analysis Plans, Flash Memos/Summary of Report, Clinical Study Reports, submission documents, correspondences with health authorities, clinical publications, reimbursement documents and other communications.
• Develops and maintains successful application of statistical excellence in design, analysis, and reporting to all phases of biosimilar development.
• Provides strategic statistical input and is a major contributor to clinical development plans.
• Ensures standards, technical quality and consistent approaches in clinical development strategy, study design and statistical analysis; maintains indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results; and contributes to statistical strategy in Amgen's Biosimilar Development.
• Ensures excellent statistical input into regulatory strategies, presentations and scientific reports for clinical trial, regulatory submission, product defense, market support, scientific presentation/publication.
• Represents Biosimilar Development on statistical matters at meetings with regulatory authorities, key opinion leaders and similar other expert bodies and defends statistical approaches internally and externally.
• Provides oversight and guidance to staff members within Amgen and in CROs in completing study deliverables according to agreed timelines following quality standards.
• Responsible for hiring, allocation, management, and development of internal statistical staff, and contributes to developing and managing goals, budgets and resource plans.
• Leads and/or participates in the development and review of Policies, SOPs and other controlled documents with CROs or within Amgen's Biosimilar Development for process improvement and operational efficiency.
• Promotes, communicates, and becomes an expert in specific statistical methodologies.
• Publishes applied research in scientific journals and books and gives presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings.
• Stays abreast of and contributes to scientific advances in the field.
• Develops and maintains long-term relationships with key statistical opinion leaders, including academics, regulators and other industry leaders.