Career Category
Clinical
Job Description
Job Purpose
This position is responsible for providing statistical expertise and leadership for clinical development and regulatory filing activities in Japan as a member of Global Biostatistical Science Japan Biostatistics.
The role will focus primarily on Japan-specific submission-related activities, including new drug application in Japan, interactions with health authorities, document preparation such as CTD, and Japan-specific analyses and interpretations.
Working closely with global and Japan cross-functional teams, this position will plan and execute the statistical strategies, analyses, documents, and regulatory responses required in Japan with a high level of quality.
Key Responsibilities
Formulation and Execution of Statistical Strategy and Scientific Rationale for Clinical Development and Regulatory Submission Activities in Japan
- Contribute statistical input from the biostatistical perspective to Japan development strategies, submission strategies, PMDA consultation strategies, responses to regulatory inquiries, preparation of regulatory documents, audit support, and other key decision-making activities.
- Provide statistical judgment on whether Japan should participate in MRCT, the need for Japan-specific additional explanations or analyses, and the interpretation of results in the Japanese population.
- Prepare and organize statistical issues, risks, recommended responses, and explanation strategies for interactions with Japanese regulatory authorities, including PMDA.
Preparation, Review, and Oversight of JNDA-related Deliverables and Japan-specific Analysis
- In the above activities, provide statistical input and prepare, support, review, and perform quality checks of necessary deliverables, including statistical documents such as statistical analysis plans, TFL shells, analysis outputs, and responses to regulatory inquiries.
- Ensure that statistical documents and analysis results are scientifically sound, explainable from a regulatory perspective, and compliant with internal and external quality standards.
- Collaborate with global and Japan team members to deliver analyses, documents, and explanatory materials required in Japan within agreed timelines.
Statistical Contribution to Clinical Trials and Japan Local Activities
- Conduct statistical evaluations related to the number of Japanese participants and its rationale in MRCTs, and the interpretability of results in the Japanese subgroup.
- Provide statistical advice on Japan local study activities, local requirements, and additional considerations for domestic clinical development.
- Provide statistical review and input from the Japan perspective on protocols, SAPs, TFL specifications, CSRs, and other study-related documents.
- As needed, lead the planning and execution of clinical trials in Japan as a Study Lead Statistician or Study Statistician.
- Contribute from a statistical perspective to evidence-generation activities in Japan, including post marketing surveillance, Phase 4 studies, publications, and support of investigators sponsored study.
Operational Excellence
- As a member of Japan Biostatistics in the Global Biostatistical Science, contribute to operational quality and efficiency, standardization, knowledge sharing, and continuous improvement.
- Demonstrate Amgen values in all aspects of work.
Basic Qualifications
- Master’s degree in biostatistics, statistics or a statistics-related field.
- 6 or more years of statistical experience in pharmaceutical, biotechnology, medical research, public health, or related fields.
- Practical experience and knowledge of clinical development, clinical trial methodology, statistical analysis, regulatory authority interactions, and the drug development process.
- Experience using statistical software such as SAS, R, and/or Python.
- Experience collaborating effectively with cross-functional teams and global members.
- Strong communication skills, with the ability to clearly explain statistical information both in writing and verbally.
- Business-level communication skills in both Japanese and English.
Preferred Qualifications
- PhD in biostatistics, statistics, epidemiology, data science or a statistics-related field.
- Experience supporting participation in multinational clinical trials from Japan, as well as Japan regulatory submissions based on MRCT data.
- Knowledge of CDISC standards, including SDTM and ADaM.
- Interest in or experience with emerging statistical methodologies, such as estimands, complex innovative designs, adaptive designs, and Bayesian methods.
- Experience leading business process improvements, standardization initiatives, internal training, or related capability-building activities.
Core Competency
- Excellent statistical judgment and scientific problem-solving skills.
- Effective communication of complex statistical concepts to non-statistical stakeholders.
- Collaborative working style across global and Japan cross-functional teams.
- High level of ownership and accountability for deliverables, quality, and timelines.
- Independent execution with limited guidance, with sound judgment in escalating risks when needed.
- Effective influence without direct authority, with the ability to drive alignment across teams.
- Comfort with ambiguity and change, supported by a positive, proactive, and solution-oriented mindset and strong execution discipline.
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