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Job Description

”Better Health for People, Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.

Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

About this Job:

• To develop and oversight statistical deliverables in clinical trials from Ph-I to IV, integrated analysis, post marketing surveillance, and medical affairs company sponsored study

• To be engaged in e-data submission with CDISC compliant format for Japan NDA filing, including consultation meeting with the agency, inspection readiness and response to inquiries from the agency

• To be engaged in standardization activities such as data standard and TLF template, collaborating with global SQS programming group

• To propose and implement new and innovative technology or tool to business improvement, such as advanced SAS macro, R/Python, AI and ML

Accountabilities:

・You have primary responsibility for:

• Managing all studies assigned to – may be responsible for one or more project level statistical programmers

• Collaboration and alignment with counterpart in global SQS on study basis

• Budget and schedule management in the studies and e-data submission for Japan NDAs, including strategy of CDISC-compliant deliverables and mitigation plans

・Equally discuss study related matters including handling Q&A properly with the agency

・Contributes to and/or leads process improvement initiatives

・Exhibits existing internal and external presence on topics of interest

Requirements:

• Bachelor’s degree or higher in statistics or related field

• Operational experience in pharmaceutical drug development with significant direct exposure to clinical development

• English communication skill in both written and verbal

• High level of expertise or experiences in pharmaceutical industry: ability to develop and execute advanced SAS programming code properly

• Understanding regulatory standard in the responsible area: ability to apply and leverage appropriate CDISC standards for statistical deliverables

• Knowledge of regulatory guidance related to statistical programming, analysis environment, e-data submission

タケダの DE ＆ I

Better Health, Brighter Future

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, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time