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Sr. Manager of Biostatistics
Job Description
Location: Tokyo, Japan
Employment Type: Permanent, Full Time
Role Overview
A global clinical research organisation is seeking an experienced Senior Manager of Biostatistics to support medium to high-complexity clinical trial programs across Phase I–IV. This role sits within a well-established biostatistics function and combines hands-on technical contribution with leadership and process improvement responsibilities.
The position will play a key role in statistical analysis, regulatory submissions, and cross-functional collaboration, with scope to mentor and supervise junior team members.
Key Responsibilities
- Lead the generation of analysis datasets and statistical analyses for medium to high-complexity clinical trials
- Support Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), and electronic regulatory submissions
- Contribute to the development and optimisation of statistical and analytical processes
- Provide leadership and guidance on data management, analysis, and reporting challenges
- Apply and advise on appropriate statistical methodologies across Phase I–IV studies
- Stay current on relevant technical and regulatory developments and advise management accordingly
- Supervise and mentor other biostatistics team members, as appropriate
- PhD in Biostatistics, Statistics, or a related discipline
- 7+ years of experience in pharmaceutical clinical trials
- Strong hands-on experience with SAS programming (or equivalent statistical software)
- Solid understanding of advanced statistical methods applied to Phase I–IV studies
- Experience supporting regulatory submissions, including ISS and ISE
- Strong knowledge of global regulatory requirements and drug development processes
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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