Statistical Programmer

Statistical Programmer
CMRQ
Tokyo Japan

Embark on a rewarding journey as a Statistical Programmer at Novo Nordisk where your expertise will drive the success of our clinical trials and ensure compliance with PMDA requirements. You will play a pivotal role in managing programming tasks contributing to high-quality outputs and collaborating with stakeholders to meet regulatory standards. Join us in a dynamic and supportive environment where your continuous development and commitment to excellence will make a real impact on the lives of patients worldwide.

Your new role
Join our team as a Statistical Programmer where youll manage key tasks in clinical trials and ensure that electronic study data submissions meet PMDA requirements. Take charge of the quality of programming deliverables for regulatory interactions while continuously developing your skills in a dynamic and collaborative environment.
Your responsibilities will include:

• Handle assigned tasks in clinical trial and cross-trial activities ensuring programming and output review align with specifications.
• Contribute to SDTM and ADaM programming trial specifications (SDRG ADRG mock TFL) and Clinical Study Reports (CSR) addressing Q&As from health authorities.
• Ensure compliance with PMDA requirements for electronic study data submissions keeping headquarters updated and collaborating with stakeholders for regulatory adherence.
• Maintain quality of programming deliverables for regulatory authority interactions through the preparation of outputs for submissions and responding to authority Q&As.
• Engage in continuous professional development by sharing best practices providing training complying with relevant SOPs and guidelines and expanding knowledge in key focus areas.

Your new department
The CMRQ Clinical Statistics team at Novo Nordisk Japan is a dedicated group of experts focused on providing statistical support for clinical trials and research initiatives. They play a crucial role in designing studies assessing data and ensuring compliance with regulatory standards while fostering collaboration across various departments. Focused on delivering high-quality results the team continually enhances their skills and methodologies to drive impactful results in the biopharmaceutical field.

Your skills & qualifications
We are seeking a resourceful and self-driven professional with strong analytical skills who is focused persistent and accountable in delivering results. The ideal candidate will be adept at managing a variable workload while keeping processes simple and eliminating unnecessary complexity. You will bring with you:

• Bachelors or preferably Masters degree in life sciences natural sciences engineering or equivalent.
• Over 3 years of programming experience ideally biological data or relevant practical experience.
• Proficient in programming languages such as SAS or R.
• Knowledgeable about CDISC and PMDA requirements for electronic study data submissions would be an advantage.
• English business fluency and Native Japanese level required.

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this we approach our work with an unconventional spirit a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose mutual respect and a willingness to go beyond what we know delivers extraordinary results.

What we offer
There is of course more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means that opportunities to learn and develop are all around us while our benefits are designed with your career and life stage in mind.

More information
You are welcome to contact our Japan Talent Acquisition team at if you have questions about the role. Be advised that we might not be able to answer queries about your recruitment status.

Deadline
Until the completion of the recruitment. Applications are reviewed on an ongoing basis.

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.

Novo Nordisk is not your typical healthcare a modern world of quick fixes we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science make healthcare more accessible and treat prevent and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real lasting change in health.

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