Role at a glance
- Job function
-
AI & Data Data Science
- Salary
- Not Disclosed
- Location
- Osaka, Japan
- Employment
- Full-time
- Experience
- Professional experience in the pharmaceutical industry, biostatistics, and statistical programming.
- Education
- A master’s degree or higher in statistics or a related field.
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Role Summary
The Manager, SQS Japan serves as the primary study statistician for clinical trials from Phase I to IV, post-marketing surveillance, and company-sponsored medical affairs studies. Based in Osaka, the role collaborates with global colleagues and stakeholders on study delivery, regulatory submissions, and agency engagement.
What You'll Do
- Provide statistical input to study design and interpretation of study results.
- Manage study budgets and schedules, and propose plans to address and mitigate risks.
- Collaborate with global Statistical and Quantitative Sciences colleagues and engage stakeholders on study matters.
- Contribute to regulatory submissions, including integrated analyses, compliant electronic data submissions, inspection readiness, and...
- Propose and implement improved methods and tools, including statistical programming, artificial intelligence, and machine learning...
- Guide junior colleagues and promote teamwork across study activities.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
A master’s degree or higher in statistics or a related field; professional experience in the pharmaceutical industry, biostatistics, and statistical programming; ability to apply appropriate statistical methodologies and assess proposed methods; understanding of relevant regulatory and statistical guidance; strong written and verbal English communication skills; ability to collaborate with stakeholders, including global colleagues; and interest in scientific development and proposing improved solutions.
Original job description
Content provided by the employer
Original job description
Content provided by the employer
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About Takeda
“Better Health for People, Brighter Future for the World” is Takeda’s purpose. We aim to create a diverse and inclusive organization where people can thrive, grow, and realize their potential while advancing this purpose. We continue to innovate and drive changes that can transform patients’ lives, and we welcome like-minded professionals to join us.
Takeda is a global, values-based, research and development-driven biopharmaceutical leader. Our values, known as Takeda-ism, have been passed down since the company’s founding and encompass Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. We bring these values to life by putting Patient, Trust, Reputation, and Business in that order.
About the Role
As Manager, SQS Japan, you will serve as a primary study statistician for clinical trials from Phase I to IV, post-marketing surveillance, and company-sponsored medical affairs studies. You will provide statistical input to study design and interpretation of results, and contribute to regulatory submission activities, including integrated analyses and compliant electronic data submissions. Based in Osaka, you will work within Statistical and Quantitative Sciences Japan and collaborate with global colleagues and stakeholders to support study delivery and agency engagement. You will also contribute to business improvement by proposing and implementing tools and approaches, including statistical programming, artificial intelligence, and machine learning. Your work will help strengthen the quality and efficiency of studies, support submission readiness, and advance the organization’s capabilities. You will also share expertise and guide junior colleagues, helping foster effective teamwork and continuous improvement.
How You Will Contribute
- Manage assigned studies as the primary study statistician, providing statistical input to study design and interpretation of results.
- Collaborate with global Statistical and Quantitative Sciences colleagues to align on study-related matters.
- Manage study budgets and schedules, and propose plans to address and mitigate risks.
- Engage with stakeholders to discuss study matters and support appropriate handling of questions from regulatory agencies.
- Contribute to regulatory submission activities, including integrated analyses, compliant electronic data submissions, inspection readiness, and responses to agency inquiries.
- Propose and implement improved methods and tools, including statistical programming, artificial intelligence, and machine learning approaches.
- Guide junior colleagues and promote teamwork across study activities.
Qualifications
- A master’s degree or higher in statistics or a related field.
- Professional experience in the pharmaceutical industry, biostatistics, and statistical programming.
- Ability to apply appropriate statistical methodologies and assess the feasibility of proposed methods.
- Understanding of regulatory and statistical guidance relevant to the area of responsibility.
- Strong written and verbal English communication skills.
- Ability to build collaborative relationships and work effectively with stakeholders, including global colleagues.
- Strong interest in scientific development and the ability to identify and propose improved solutions.
Takeda Compensation and Benefits Summary:
Allowances: Commutation, Housing, Overtime Work etc.
Salary Increase: Annually, Bonus Payment: Twice a year
Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
Flexible Work Styles: Flextime, Telework
Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
Important Notice concerning working conditions:
It is possible the job scope may change at the company’s discretion.
It is possible the department and workplace may change at the company’s discretion.
Locations
Osaka, JapanWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeAbout the company
Takeda
Large Enterprise
Takeda is a global biopharmaceutical company headquartered in Tokyo, Japan, with a rich history spanning over 240 years. Specializing in the research, development, and commercialization of innovative medicines, Takeda focuses on therapeutic areas such as oncology, gastroenterology, neuroscience, and rare diseases. Committed to improving patient outcomes, the company harnesses advanced technologies and scientific expertise to deliver breakthrough therapies and enhance healthcare worldwide. Takeda's dedication to sustainability and social responsibility underscores its mission to strive towards better health for people and communities across the globe.