Description
You will lead statistical planning and delivery for clinical research in Japan, working with cross-functional teams to design trials, analyse data, and support regulatory interactions.
Responsibilities:
- Act as primary statistical lead for Japan projects, contributing to study design, analysis plans, and interpretation of results.
- Collaborate with global statisticians and local cross-functional teams to align trial design and analysis across regions.
- Prepare statistical input for regulatory interactions and support submissions to Japanese health authorities.
- Oversee external statistical partners and vendors to ensure quality, timelines, and cost control.
- Apply modern statistical methods, including adaptive and Bayesian approaches, to enable efficient and ethical study designs.
- Coach and mentor statisticians and non-statistical colleagues, promoting good statistical practice and reproducibility.
Basic Qualifications:
- Degree in statistics, biostatistics, mathematics or a closely related quantitative discipline.
- At least 5 years of experience working as a statistician in randomized clinical trials, with industry or CRO experience.
- Practical experience in clinical trial design and statistical analysis.
- Proficiency with statistical software such as R or SAS and working knowledge of clinical trial data formats and conventions.
- Business-level English and fluent Japanese.
- Strong communication skills with experience explaining statistical concepts to non-statisticians.
Preferred Qualifications:
- PhD or advanced degree in statistics, biostatistics, or related field.
- Experience with regulatory submissions and direct interactions with Japanese regulatory authorities.
- Knowledge of adaptive designs, Bayesian methods, or other innovative statistical approaches.
- Background in one or more therapeutic areas relevant to our work in Japan.
- Experience managing external vendors and contract statisticians.
- Familiarity with data science tools and modern workflows oriented to reproducibility and automation.
Working Arrangement: This role is hybrid, based in Japan, combining on-site work with flexible remote days.