Principal Biostatistician Medical Affairs - Mechelen,BE/Leiden,NL/Basel,CH

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville & Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), the UK (London), Germany (München), and in the US (Boston).

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.

We are looking for a Principal Biostatistician Medical Affairs- Mechelen,BE/Leiden,NL/Basel,CH

You will be part of the expanding Biostatistics team. Our mission is to apply the appropriate statistical methodology to deliver the portfolio through collaborative scientific leadership and operational excellence. Our first medicine is approved and available to patients in Europe, we are looking for a biostatistician to lead the post approval statistical activities in rheumatoid arthritis and ulcerative colitis.

Your Role:

You will be responsible for, or involved in:

  • Lead statistical cross-functional teams to generate publications, presentations, and posters in collaboration with Medical Affairs
  • Build relationships with other Medical Affairs' functions to effectively collaborate on designs that may involve real world elements, and to ensure that the objectives meet the needs of the late phase environment
  • Support KOL engagement activities supporting HTA and commercialization, including advisory boards, publication meetings and HTA preparations
  • Implement a strategic publication plan in collaboration with Medical Affairs
  • Perform additional analyses required for HTA submissions of phase III and IV data
  • Analyses of and design of observational studies (both prospective and retrospective)
  • Gain insight in the specific disease area and the competitive landscape through focused literature search and summarizing of publicly available data.
  • Support PASS/PAES from conception and setup to execution, reporting and filing
  • Support PRO investigations
  • Perform work in full compliance with applicable internal and external policies and procedures

Job requirements

Who are you?

  • You have a PhD or a Master degree in (bio)statistics or related field and have a strong interest in keeping up to date with proceedings on statistical methodology in relevant fields.
  • You have 5 to 15 years of experience in drug development of life sciences and you are able to apply modelling, simulation and data visualization using SAS and/or R. Experience in the Medical Affairs area would be a valuable asset.
  • You are able to lead the statistical activities independently, and lead/mentor your team of biostatisticians and programmers to high-quality and timely delivery of outputs.
  • You are able to quickly acquire in-depth knowledge about the specific disease area you will be working in.
  • You are a keen learner, a strategic thinker and knowledgeable about the various aspects of clinical development and regulatory requirements.
  • You have excellent written and oral communication skills and the ability to work in a multi-disciplinary environment.

What’s in it for you ?

You will be part of an amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos : together we can make it happen…!