統計分析マネージャー/ Statistical Analysis Manager

A global pharmaceutical company is looking for a Statistical Analysis Manager. The chosen applicant will provide statistical expertise and leadership for clinical development and regulatory submission activities.

Responsibilities:

• Provide statistical input to Japan development strategies, submission strategies, PMDA consultation strategies, regulatory responses, regulatory documents, audit support, and key decision-making activities
• Provide statistical judgment on Japan's participation in MRCT, Japan-specific additional analyses or explanations, and interpretation of Japanese population results
• Prepare and organise statistical issues, risks, recommended responses, and explanation strategies for interactions with PMDA and other Japanese regulatory authorities
• Provide statistical input and perform preparation, review, support, and quality checks of statistical deliverables, including SAPs, TFL shells, analysis outputs, and regulatory responses
• Ensure statistical documents and analyses are scientifically sound, regulatorily acceptable, and compliant with internal and external quality standards
• Collaborate with global and Japan teams to deliver analyses, documents, and materials required for Japan within agreed timelines
• Evaluate statistical considerations for Japanese participation in MRCTs and interpretability of Japanese subgroup results
• Provide statistical advice on Japan local studies, local requirements, and domestic clinical development considerations
• Review protocols, SAPs, TFL specifications, CSRs, and other study documents from a Japan perspective
• Lead or support planning and execution of Japan clinical trials as Study Lead Statistician or Study Statistician as needed
• Contribute to post-marketing surveillance, Phase 4 studies, publications, and investigator-sponsored studies from a statistical perspective

Requirements:

• Master’s degree in biostatistics, statistics, or a statistics-related field
• More than 6 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, or Python
• Experience collaborating effectively with cross-functional teams and global members
• Strong communication skills, with the ability to clearly explain statistical information
• Business level Japanese and English

Preferred Requirements:

• 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, standardisation initiatives, internal training, or related capability-building activities

About the Company:

A global pharmaceutical group, this organisation is an internationally recognised name in biotechnology. Responsible for a range of medicines aimed at treating human illnesses, this company supplies medical professionals and patients across the world.

Keywords:

統計, 製薬, 医学研究, 外資系

Job Ref: HVCB5K