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💸 239497.0 - 271577.0 USD per year
🔍 Biotechnology
🏢 Company: careers
- 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
- 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.
LeadershipData AnalysisPeople ManagementSAS EGData StructuresRDBMS
Posted about 9 hours ago
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