Experienced Biostatistician

Would you like to have a key role in the clinical development in ALK and have the opportunity to influence the strategy on how to achieve the organizational goals of ALK?

Does it appeal to you, to contribute the statistical deliverables that are the core of ALKs future submissions in North America, Europa or China?

If yes, then a position as Biostatistician in ALK will be of interest to you.

As a Biostatistician, you will be a part of the Biometrics Department including Biostatistics, Clinical Data Management and Statistical Programming with 15 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 variation applications, support to marketing and publications.

Fields of responsibility

• Providing statistical input to trial designs, clinical trial protocols, briefing books, summary documents and publications
• Generate, present and discuss trial results both with internal and external collaborators
• As statistical expert, you will take part in the interaction with regulatory authorities, partners and key opinion leaders
• Planning more high-level statistical tasks as well as utilisation of statistical tasks via SAS programs and macros
• Work closely together with the other Biostatisticians, Statistical Programmers and Data Managers in the department as well as being 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 minimum MSc level or equivalent
• At least 3 years of experience in clinical development within the pharmaceutical industry or CROs
• Good knowledge of SAS programming
• Knowledge of statistical regulatory guidelines within the pharmaceutical industry in North America and Europe as well as 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 improve efficiency and resolve scientific as well as technical issues
• Good communications skills and fluent in oral and written English

We offer

ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization, 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 who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization, and our offices offer a green view of the DTU Scion science park in Hørsholm.

Deadline

21 August 2022.

Contact

For further information on the position please contact Head of Biometrics, Peter Meisels, +45 61 91 11 77.