Novo Nordisk A/S
Gladsaxe, 1 stilling
- Biostatistics and Data Management
- Denmark - Søborg
Do you possess expert biostatistical competences and do you enjoy teaching, knowledge sharing and process optimisation? You may be our new principal statistician.
In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. We ensure medical and scientific documentation for clinical submissions and authorities while ensuring that the process lives up to uniform global standards, regulations and business ethics.
About the department
The biostatistics function currently consists of 230 Statisticians and Statistical Programmers worldwide. The position is based in Biostatistics Anchor which is a team of eleven including four Statisticians supporting the global biostatistics function as statistical experts.
The job
You will support Statisticians in the clinical projects giving expert advice on complex statistical challenges. Based on your continuous update of your knowledge of the view of the regulatory authorities, you will also provide support in interactions with regulatory authorities and external collaborators.
Training of statisticians and other professionals is also an important part of the job, both in relation to on-boarding of new colleagues and to more experienced colleagues. You will spend as a minimum 4 weeks a year doing training.
You are responsible for review of selected key deliverables within our clinical development process e.g. clinical trial protocols and result meeting presentations across our clinical projects.
Development of methods and processes, as well as knowledge sharing is continuously on-going in Novo Nordisk. You will be involved in process improvement within Biostatistics and across our Global Development organisation. You will also take part in development of our internal Biostatistics guideline and you will facilitate the implementation of global standards for analysing and reporting clinical data.
You must expect to collaborate with many different areas of Novo Nordisk and both within Denmark and across borders with our affiliates in the US, India, China and Japan, as well as our outsourcing partners around the world.
We expect you to take part in our dedicated efforts to make Biostatistics a good and challenging place to work. In exchange we offer great opportunities for on-going training to ensure your continued competency development.
Qualifications
You have a solid theoretical background in statistics corresponding to PhD level and at least eight years of experience with clinical research in the pharmaceutical industry. You have expert knowledge of biostatistical methods and extensive experience with practical application of biostatistical methodology and statistical software including SAS. You have experience with the process of drug applications with the FDA and EMA. Experience with project management and teaching will be considered an advantage.
You are able to handle many assignments concurrently without compromising the quality of your work and you quickly adapt from one therapeutic area to another. You are a result oriented person with a strategic mind-set, a keen business perspective, personal impact and integrity. You work independently, and you are proactive with a strong focus on quality. We expect that you remain high spirited, also when things are moving fast. You have excellent collaboration and communication skills.
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Contact
For further information, please contact Anders P. Riis at +45 3079 5583.
Deadline
4 January 2016.
