Principal Biostatistician

Would you like to have a key role within clinical development at ALK and have the opportunity to influence the strategy on how to achieve ALK’s 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, Europe, or China as well as to contribute to the development of new products and indications?
If yes, then a position as Principal Biostatistician in ALK will be of interest to you.

The position
As a Principal 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.

Your fields of responsibility in this role:

• Providing statistical input to clinical development plans, 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 programming.
• Work closely together with the other Biostatisticians, Statistical Programmers and Clinical 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

• A solid theoretical background in mathematical statistics corresponding to minimum MSc level or equivalent.
• At least 10 years of experience in clinical development within the pharmaceutical industry.
• A suitable candidate will have a good awareness of new trends in statistics and a profound knowledge of statistical regulatory guidelines within the pharmaceutical industry and the ability to support other biostatisticians to utilise new statistical methods.
• Good knowledge of SAS programming.
• Insight into pharmacokinetics and pharmacodynamics would be 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 spoken and written English.

Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. 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. You will be part of an engaged and informal team who values skill and knowledge creation. The culture is informal yet professional, encouraging a strong work-life balance while driving performance excellence.

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.

Do you want to learn more about our company, we encourage you to visit us at www.alk.net.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 12 January 2025.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 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.

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

We are looking forward to hearing from you!