Statistician

Key Skills

English Proficiency, SAP, Statistics

Job Description

Are you passionate about statistical analysis? Do you want to participate in a wide variety of global clinical development projects? Then you may want to explore this incredible opportunity in Novo Nordisk Japan as Statistician. Join us and be part of a world-renowned pharmaceutical company whose aim is to change patients lives. 

Apply now!

About the Department

Novo Nordisk is a global healthcare company with more than 100 years of innovation and supervision in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases.

The position of Statistician is to be in Tokyo, and report to Senior Director, Strategic Pharmacovigilance & Scientific Data Generation.

The Position

As the Statistician, you will be accountable for all statistics within the designated projects/trials and optimize the clinical development plan statistically. You will complete the protocol, statistical analysis plans (SAP), data handling, clinical trial report (CTR), non-interventional study report (NSR) , common technical document (CTD) and regulatory documents statistically. You will also drive Case Report Form (CRF), Trial Validation Plan (TVP), CTR data flow plan input, CTR/NSR workflow plan, Statistical Programming Specification (SPS) as well as perform statistical analysis and programming of output according to specification.

Other tasks include, but are not limited to:

• Drive trial outline (TO) development including sample size calculation, protocol development including statistical section of protocol. Support to derived programming according to industry standards. Interpret trial results and present results for the project and upper management. Day-to-day trial execution and coordination within the trial stats team. Ensure project statistical programming specification input and statistical input to design of trial.
• Do presentation and negotiation of clinical development program at meetings with regulatory authority/Pharmaceuticals and Medical Device Agency (PMDA). Develop submission document(s), and post-submission activities to achieve regulatory approval and optimal labelling to allow the successful launch of the drug.
• Share better practices and increase awareness of statistics within the designated projects and Clinical Medical Regulatory development division. Act a part of the standardization and globalization of the statistical activities.
• Be responsible for continuous development of own skills (statistical knowledge, English communication skill, needed training and education) according to individual development plan (IDP).
• Keep Headquarters up to date on PMDA requirements on electronic data submission, review e-data consultation documents by checking e-data to submit to PMDA and coordinate e-data consultation.

Qualifications

• Minimum master’s degree of Science in Statistics or equivalent.
• Minimum of 3 years of experience as a statistician within the pharmaceutical area or equivalent knowledge through relevant experience.
• Good knowledge of Good Clinical Practice (GCP) and statistical guidelines within drug development.
• Experience with a broad range of statistical tasks, statistical software, and in-depth experience with at least one statistical software package.
• Experience with communication of statistical issues and presentations. Business-level in English (writing and speaking) is required.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Deadline: Until the completion of recruitment.

Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.