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Biostatistics Leader

Posted 24 Mar 2024
Work experience
1 to 3 years
Full-time / part-time
Full-time
Job function
Degree level
Required language
English (Fluent)

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Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Basel (Switzerland) and in Boston (US).

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 Biostatistics Leader - with the possibility to work from Mechelen (BE) / Leiden (NL) / Romainville (FR) or Basel (CH)

You will be part of the rapidly expanding Biostatistics team. The Biostatistics Leader is a functional expert in the field of clinical trial biostatistics, and as such supports the Clinical Development Team (CDT) in providing expert statistical and strategic input into the compound development and is to ensure the submission package will meet all necessary regulatory requirements from a statistical perspective. He/she oversees the coordination of the External Service Providers (ESP) with respect to Biostatistical activities and deliverables and supervises biostatisticians working on their project. You may or may not have line management responsibilities. You will be reporting to the Head of Biostatistics.

Our mission is to apply the appropriate statistical methodology to deliver the portfolio through collaborative scientific leadership and operational excellence. Our core business is the design and analysis of Phase 1-3 clinical trials and accurate interpretation and communication of statistical results and concepts to the clinical team.

Your role

  • Representing Biometrics as a standing member to CDT meetings and to the Project Team as an ad-hoc member.
  • Providing expert input into the design and analysis of phase 1-3 clinical trials
  • Providing guidance to biostatistician(s) responsible for the individual studies, especially by clear communication, coaching, empowerment and good resource planning
  • Providing strategic input into the compound development plan
  • Representing Biometrics in meetings with regulatory agencies
  • Maintaining a company-wide project focus while strengthening the function

Requirements

Who are you?

  • You have a PhD or a Master degree in (bio)statistics and a strong interest to keep up to date with proceedings in statistical methodology in relevant fields.
  • An open mind towards innovation
  • At least ten years of experience in drug development or life sciences.
  • Relevant experience in submission-related activities
  • You are able to quickly acquire in-depth knowledge about the specific disease area and are knowledgeable about clinical pharmacology.
  • 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 in English and the ability to work in a multi-disciplinary environment.
  • You are a team player and possess excellent interpersonal skills.

What’s in it for you ?

You will be part of a fast growing and 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…!

Galapagos is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Galapagos’ pipeline comprises Phase 3 through to discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications.

Healthcare
Leiden
1,000 employees