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About the Role

This position provides statistical expertise and leadership for clinical development and regulatory filing activities in Japan, focusing on Japan-specific submission activities, including new drug applications, health authority interactions, document preparation, and analyses. The role involves planning and executing statistical strategies, analyses, documents, and regulatory responses with a high level of quality, working closely with global and Japan cross-functional teams.

Responsibilities

Formulate and execute statistical strategy and scientific rationale for clinical development and regulatory submission activities in Japan.
Contribute statistical input to Japan development strategies, submission strategies, PMDA consultation strategies, and responses to regulatory inquiries.
Provide statistical judgment on Japan's participation in MRCTs, the need for Japan-specific explanations or analyses, and interpretation of results in the Japanese population.
Prepare and organize statistical issues, risks, recommended responses, and explanation strategies for interactions with Japanese regulatory authorities.
Provide statistical input and prepare, support, review, and perform quality checks of JNDA-related deliverables and Japan-specific analyses.
Ensure statistical documents and analysis results are scientifically sound, regulatorily explainable, and compliant with quality standards.
Collaborate with global and Japan team members to deliver analyses, documents, and explanatory materials within timelines.
Conduct statistical evaluations related to the number and rationale of Japanese participants in MRCTs and subgroup interpretability.
Provide statistical advice on Japan local study activities, local requirements, and domestic clinical development considerations.
Provide statistical review and input on protocols, SAPs, TFL specifications, CSRs, and other study-related documents from a Japan perspective.
Lead the planning and execution of clinical trials in Japan as a Study Lead Statistician or Study Statistician, as needed.
Contribute statistically to evidence-generation activities in Japan, including post-marketing surveillance, Phase 4 studies, publications, and investigator-sponsored studies.
Contribute to operational quality, efficiency, standardization, knowledge sharing, and continuous improvement within Japan Biostatistics.
Demonstrate Amgen values in all aspects of work.

Requirements

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.

Skills

Statistical expertise
Clinical development
Regulatory filing
Japan-specific submission activities
New drug application in Japan
Health authority interactions
CTD preparation
Statistical analysis and interpretation
Statistical strategy planning and execution
SAS
R
Python
Cross-functional team collaboration
Global team collaboration
Written communication
Verbal communication
Japanese language proficiency
English language proficiency
CDISC standards (SDTM, ADaM)
Emerging statistical methodologies (estimands, complex innovative designs, adaptive designs, Bayesian methods)
Business process improvement
Standardization initiatives
Internal training
Capability building
Statistical judgment
Scientific problem-solving
Communication of complex statistical concepts
Collaborative working style
Ownership and accountability
Independent execution
Risk escalation
Influence without direct authority
Driving alignment
Comfort with ambiguity and change
Proactive mindset
Solution-oriented mindset
Execution discipline

Location

Japan

Work Type

Full-time

Experience Level

6+ years of statistical experience

Education Level

Master's degree in biostatistics, statistics or a statistics-related field
PhD in biostatistics, statistics, epidemiology, data science or a statistics-related field

About the Company

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen