Head Biostatistics - BE, Mechelen
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), UK (London), Germany (München), and in 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 Head Biostatistics.
Scope of the job
The core purpose of the role Head Biostatistics is the strategic management and leadership for the Biostatistics department to ensure flawless execution through operational excellence and scientific rigour, across all projects of the development portfolio in an effective and compliant manner.
You will lead a group of approximately 15 professionals in total in the area of biostatistics, consisting of biostatistical leaders, a team of biostatisticians, and a team of data scientists, both lead by a dedicated Team Leader.
- Determine mid- and long-term strategy for the Biostatistics department, fitting with the Biometrics and company strategy
- Ensure recruiting appropriately qualified staff, and staff personal development through continuous training of staff
- Ensure high quality deliverables for the functional area of responsibility
- Ensure delivery of activities / deliverables for studies and projects within timelines
- Ensure appropriate and required processes and procedural documents are in place in line with (legal) requirements, timely training, and compliance by team members
- Ensure appropriate tools and systems are available and are meeting the applicable validation requirements from a business owner perspective
- Contribute to strategic vendor management in collaboration with procurement and other departments
- Ensure sound scientific input in Development processes and deliverables
- Contribute to merger & acquisition activities from Biostatistics perspective
- Identify strategic external partnerships that drives internal outcomes
- Proactively takes the lead to identify opportunities for innovative solutions to address project critical needs efficiently and effectively
- Represent your functional area during audits and inspections on departmental level, and ensure timely CAPA follow-up
- Act as Clinical Development Committee (CDC) member, reviewing clinical documents like protocols, study reports
- Partner with other statisticians in developing publications (e.g. manuscripts, oral presentations, posters, abstracts, and internal technical reports) and creating software
- Serve as initial consultation contact for new projects from Biostatistics perspective.
- Maintain and grow internal customer base and build loyal relationships with other functional areas within Biometrics as well as other internal customers.
- Actively build working relationship with Galapagos partner Gilead, and possibly others, in the area of Biostatistics
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.
- You have previous line management experience and/or a demonstrated record of project-based leading.
- You have a minimum of 10 years’ experience in pharmaceutical industry and drug development
- You have outstanding communication, organizational and leadership skills, with a successful track record of collaborating with cross-functional teams and delivering on objectives in defined timelines.
- You have an open mind towards innovation
- As a leader, you promote an open and supportive climate and a collaborative organization.
- You are open to work Belgium based.
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…!