Would you like to have a key role in clinical development and help influence the strategy on how to achieve our organisational goals? Does it appeal to you, to contribute to the statistical deliverables that are the core of ALKs future and current products in North America, Europa, and China as well as to contribute to early development programs of new compounds?

The position
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 authorisation of new drugs as well as variation applications, support to marketing and publications.

Your field of responsibility will be:

• 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.
• Maintain and update the Biometrics steering documents and Biometrics programming environment.

Your profile
We expect that you have:

• 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.

Become a part of ALK
ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. We provide an attractive working environment for individuals looking for both personal and professional development. You will be part of an engaged and informal team who values skill and knowledge creation.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 11 August 2024.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Hence, we prefer that you do not add images in your application documents. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

Do you want to learn more about our company, we encourage you to visit us at www.alk.net. For further information regarding the position please contact Head of Biometrics, Peter Meisels on +45 61 91 11 77.

We are looking forward to hearing from you!