Manager, Statistical Programming, SQS Japan

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Job Description

Statistics:

• Properly to input statistical considerations in study design and interpretation of study result for non-clinical trials, clinical trials from Ph-I to IV, post marketing surveillance, and medical affairs company sponsored study and to implement statistical analysis for these studies as primary study statistician (J1 may be responsible for one or more projects level statistician)
• To contribute to NDA filing activities, including integrated analysis, and e-data submission with CDISC compliant format, inspection readiness and response to inquiries from the agency

CDISC/SAS:

• To develop and oversight statistical deliverables in clinical trials from Ph-I to IV, post marketing surveillance, and medical affairs company sponsored study
• To be engaged in e-data submission with CDISC compliant format, 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 SAS programming group
• To propose and implement IT technology or tool to business improvement, such as SAS macro, R/Python, AI and ML

Accountabilities:

You will have primary responsibility for:

• Managing all studies assigned
• Collaboration and alignment with counterpart in global SQS on study basis
• Budget and schedule management in the studies, including proposal of risk management and mitigation plans
• Equally discuss study related matters including handling Q&A properly with the agency

Requirements:

• Bachelor’s degree or higher in statistics or related field
• English communication skill in both written and verbal
• High level of expertise or experiences in pharmaceutical industry: ability to use statistical methodologies properly
• Understanding regulatory standard in the responsible area: ability to estimate the feasibility of the proposing methodology
• Knowledge of regulatory and statistical guidance

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.

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