Job Posting

Manager, Statistical Programming, SQS Japan

Osaka, Ōsaka

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Job Type: Full Time
Job Level: Senior
Travel: Minimal (if any)

Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.

Job ID R0142669 Date posted 01/31/2025 Location Osaka, Ōsaka

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’sPrivacy Noticeand 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

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

Takeda isa global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, whichhas been passed down since the company’s founding. Takeda-ismincorporatesIntegrity, 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

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During my 20-year journey here, I’ve been fully supported by my colleagues, and I can’t say enough about our rich internal talent and the long-standing values that drive our decisions as we work to develop important medicines for the patients we serve.

Doug Coffman - Head, R&D Asset Transition & Integration Office, R&D Regional & Business Operations

When making any type of decision, the first thing we ask is 'how will this impact patients?’ Ultimately, we’re laser focused on the best interests of the patient, and I truly believe we follow through on that.

Meredith Culp - VP, Head of Neuroscience Therapeutic Area Strategy & Operations and Head of Global Development Integration Office

Alison Handley, Head, Center for External Innovation

The heart of our work

Shining a light on new perspectives

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

Integrity
Fairness
Honesty
Perseverance

Working at Takeda

Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.