Senior Standard Developer
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Søborg
Do you wish to experience a highly professional and engaging global environment bringing clinical projects to market? Do you want to apply your skills and quality mind-set in translating regulatory and business needs into fit-for purpose data standards, or apply your flair for technology and programming into adapting our standards and tools to the evolving e-clinical landscape? Then our department offers an exciting opportunity as a Standards Developer. Apply Today for a life-changing career! The Position Our department is responsible for developing and maintaining an efficient set of data collection & reporting standards, systems, processes, programs and tools used in the generation of regulatory compliant clinical data. We work in multi-functional and international teams on a variety of clinical and technical projects across trial operations, data management and biostatistics. The positions offer a unique opportunity to gain valuable experience and insight across a broad set of functions in the drug development process. Based on your skills and experience, your tasks will focus on one or more of the following areas: Define and develop visualisation tools and supporting the evaluation of ML/AI using python, SAS or other programming languages.
Develop and optimise SAS programs generating SDTM packages for all clinical trials.
Define and develop CDASH/SDTM compliant clinical data standards, and support in their continuous improvement.
Research external and internal requirements and industry best practices (either in the use of systems or in regulatory requirements like CDASH, SDTM and ICSR) to identify improvement opportunities and provide expert advice to the organisation.
Improve our processes and systems through leveraging new and existing technology solutions.
Support our clinical studies in ensuring compliance to business requirements, and use of standards and systems, through expert advice, just-in-time training and system implementations.
Qualifications To excel in this role, you have: A university degree within IT, natural sciences or other field of relevance.
Analytical approach to tasks and an ability to quickly grasp the overview and inter-relationship of discrete datatypes and related systems.
Good experience programming in one or more technologies, and you are confident in your ability to learn new ones.
Ability to manage complex and critical communication in a clear, concise and timely fashion is a must, and experience with structured authoring is a benefit.
High attention to detail and thrive when performing careful meticulous work. You are able to work independently, take on responsibility and show initiative.
On a personal level, you are team oriented and enjoy working with people from different professional backgrounds. You are eager to see things moving forward and possess a certain drive to make things happen which has a positive and motivating effect on your team members. Fluency in oral and written English is essential. About the Department In Global Development, we are responsible for managing clinical drug development worldwide, ensuring that the process lives up to uniform global standards, regulations and business ethics while delivering viable products that make a difference to patients and ultimately benefit society. Our department, Data Standards and Outreach, is a part of Data Science and consists of 12 enthusiastic and highly engaged people with both broad and specialist knowledge. The composition of industry acknowledged Subject Matter Experts and innovative mindsets provides optimal training grounds for anyone with a desire to boost their pharma industry knowledge to the highest level. Working at Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Martin Lindhard, Director Data Standards & Outreach at +45 30 75 10 60. Deadline 31 October 2023. Please do not hesitate to apply. Applications will be evaluated as they are received. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. 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.
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 3.10.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forretningsudvikler
- Søborg
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