メディカル・バイオ - メディカルデータマネジメント
メディカル・バイオ - 統計解析

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 you'll 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.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

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:

Bachelor's or preferably Master's 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.

■職種未経験者：不可