ALK · Publicerad 9 apr 2019

Position
Would you like to have a key role in the clinical development within ALK?

In order to adapt to our markets in North America and China, ALK Biometrics is expanding the regulatory focus more globally to include US, Canada and China. By the end of 2019, we will have a complete CDISC framework set-up to accommodate FDA submission requirements.

Does it appeal to you to take responsibility of the statistical deliveries that are the core of ALK's future submissions to North America, Europa or China?

If yes, then the position as Principal Biostatistician may be of interest to you.

As a Principal Biostatistician, you will be a part of the Biometrics Department including Biostatistics, Clinical Data Management and Statistical Programming with 12 employees. Biometrics contributes to the entire drug development process from discovery to market. We are responsible for all clinical data deliverables for clinical trials, marketing authorization of new drugs as well as varying applications and support to marketing.

Field of responsibility
  • Provide statistical input to clinical development plans, trial designs, clinical trial protocols, briefing books, summary documents and publications
  • Generate, present and discuss trial results with internal and external collaborators
  • As a statistical expert, you will interact with regulatory authorities, partners and key opinion leaders
  • Plan and coordinate both standard and more high-level statistical tasks as well as drive the utilisation of statistical tasks via SAS macros
  • Work closely together with the other Biostatisticians, Statistical Programmers and Data Managers in the department and be a part of cross-disciplinary development teams
  • Communicate statistical issues and ideas to non-statisticians
Your qualifications
  • A solid theoretical background in statistics corresponding to MSc level or equivalent
  • Profound knowledge of SAS programming as well as statistical regulatory guidelines in North America and Europa
  • Knowledge of CDISC requirements for regulatory submissions is an advantage
  • Ability to work independently, handle multiple priorities within timelines, and collaborate with other functions to resolve issues and improve efficiency
  • At least 5 years of experience in pharmaceutical companies or CROs
  • Excellent communication skills and fluent in oral and written English
We offer
ALK provides a dynamic and pleasant work environment with inspiring and challenging assignments. The results of your efforts will be significant throughout the organisation and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team which values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organisation and our offices offer a green view of the DTU Scion Park in Hørsholm.

Contact

If you would like any additional information on this position please contact Head of Biometics, Peter Meisels, +45 61 91 11 77.

How to apply
Please click on apply and kindly remember to attach a letter of motivation and CV. We are looking forward to hearing from you.
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Sista ansökningsdag
8 juni 2019
Ort
Utland
Anställning
Tillsvidareanställd
Omfattning
Heltid
Antal Tjänster
1

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