Standards Programming Specialist in Global Development

Do you thrive by working in an engaged and highly professional organisation where you can use your programming skills and experience with data standards in a global environment? Then you may be our new Programming Specialist.

In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. We provide medical and scientific documentation for clinical submissions and authorities and ensure that the process lives up to uniform global standards, regulations and business ethics. We work in Global Project teams with focus on delivering viable products that make a difference to patients and ultimately benefit society.

About the department
Clinical Data Standards is a part of Global Development and our main responsibility is to develop standards for collection and reporting of clinical data and to support the use of clinical data standards from early trial design to submission of data and documentation in accordance to the international data standard Clinical Data Interchange Standards Consortium (CDISC).

Our department consists of 29 enthusiastic and highly engaged people working closely with multi-functional and international teams on a variety of clinical and technical projects in a pleasant and informal atmosphere.

The position
Your primary responsibility will be to develop and optimise a library of standard programs that produces CDISC compliant data for all clinical trials. This entails driving the programming efforts needed when upgrading to new data and terminology versions or when optimising the program library to align with industry best practices. Furthermore you will be responsible for training the stakeholders that will utilise the programs.

Besides programming you will be part of driving the development and maintenance of clinical data standards and related processes in alignment with the needs of clinical projects, clinical systems and processes, external regulatory requirements and industry best practices and you will take part in multi-stakeholder data standardisation projects.

You will have close collaboration with our primary stakeholders such as Biostatistics, Data Management, Study Data Tabulation Model (SDTM) Programmers, Risk Based Monitoring and Trial Management in order to define optimal data standards to be used across clinical projects in Novo Nordisk.

You will be expected to travel 1-2 weeks per year to our affiliate in Bangalore, India.

You have a B.Sc., M.Sc. or Ph.D. within IT, Natural Sciences or other relevant degree and you bring 5-8 years of extensive knowledge of and experience with advanced programming. Preferably you have experience with SAS programming, knowledge of the SDTM data model, Define-XML, Study Data Reviewer’s Guides, clinical development, driving IT projects and IT system development methodologies.

We expect you to be flexible and efficient combined with an ability to manage several challenging tasks in parallel without compromising quality.

The job requires that you are able to work very well in a team with diverse skill sets and varying levels of expertise with clinical data standards. You will play an important role in the ongoing competency development of and support to the department and its many stakeholders.

As a specialist we expect you to be a driver, show initiative, work independently, seek guidance when needed and take responsibility for delivering high-quality results on time. Since you will be working in an international setting we expect you to be fluent in English, written and spoken.

Working at Novo Nordisk
In Novo Nordisk, your skills, commitment and ambition help us to improve many people's lives. Our ambitious teams strive to perfect existing drugs, devices and processes and work toward developing the next generation of care. We offer an interesting and challenging job with a high degree of individual responsibility and a chance to work alongside the best in the field.

For further information, please contact Trine Næstoft at +45 3075 2135 or Martin Lindhard at +45 3075 1060.

6 May 2018.

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