Principal Biostatistician

ALK; Hørsholm Kommune; Hybrid; DKK 800,000 - 1,100,000; Full time

Job summary

ALK is seeking a Biometrics leader with a strong statistical toolkit and at least 10 years in pharmaceutical clinical development. The role combines scientific leadership with regulatory interaction, overseeing regulatory strategy, study designs, and statistical inputs across trials and publications.

The position sits in ALK's Biometrics department, collaborating across Biostatistics, Clinical Data Management, and Statistical Programming to shape evidence for products and indications worldwide.

Qualifications

• Solid MSc level theoretical background in statistics or equivalent.
• At least 10 years of experience in clinical development within the pharma industry.
• Strong knowledge of statistical regulatory guidelines in pharma.
• Familiar with SAS programming; Python/R knowledge is a plus.

Responsibilities

• Shape regulatory strategy and the statistical thinking behind evidence.
• Lead when authorities return questions and craft the statistical response.
• Scope new development opportunities and turn ideas into trials.
• Run scenario work to compare options and implications.
• Explore what studies can still support with existing data.
• Act as sparring partner across the organisation translating needs into stats.
• Contribute statistical input across protocols, briefing books, and publications.
• Represent statistics with regulators, partners, and key opinion leaders.
• Expand the department's methodological range with new approaches.

Skills

SAS programming

R or Python

Statistical design

Communication skills

Education

MSc in Statistics

Tools

SAS

R

Python

Job description

Do you bring advanced statistical expertise and insights to shape how evidence is built, not merely to analyse data? If so, this Biometrics role at ALK could be your next career challenge.

ALK develops allergy immunotherapy treatments that modify the immune system's response to allergens rather than just treating symptoms. Our clinical trials generate the evidence that gets those treatments to patients in North America, Europe, and China, and that supports the new products and indications we are building next.

This is not a role in taking a statistical analysis plan and executing it. It is about being the person others come to when a question is still open: an authority comes back with a question that needs more than a standard answer, a submission in a new market needs a route mapped out, a development opportunity is still a rough idea. That kind of work is growing here, which is why the role exists. You demonstrate deep statistical proficiency, a keen sense for which methods are fit for purpose, and the confidence to advocate for better solutions.

A forward-looking mindset is essential in this role. Artificial intelligence is reshaping statistical practice and will continue to do so. What will not change is the need for accountable scientific leadership: clearly articulating assumptions, making principled design decisions, interpreting results with rigour, and standing behind the conclusions we endorse. We seek a colleague who advances the department and drives continuous improvement, rather than simply maintaining the status quo.

You will be part of Biometrics, a department consisting of Biostatistics, Clinical Data Management, and Statistical Programming. We support the full product lifecycle, from early development through marketing authorisation and variations to publications and post-market support. We combine the agility of a small team, where individual insight can rapidly shape direction, with the breadth to provide visibility across the entire development arc.

What you will be doing

• Shape regulatory strategy, and the statistical thinking behind how we build and defend the evidence.
• Take the lead when authorities come back with questions, working out the statistical response and the argument behind it.
• Scope new development opportunities. Turn a rough idea into a project and trial outline: what is needed, what is feasible, and how to sequence it.
• Run scenario work across projects, so decisions get made with a clear view of what each option would mean.
• Explore what our concluded studies can still support, and where there is more to get from data we already have.
• Be a sparring partner across the organisation. Listen to what colleagues are trying to achieve, translate it into statistical terms, and propose a way forward.
• Contribute statistical input across the line: trial designs, protocols, briefing books, summary documents, publication review, and due diligence.
• Represent statistics with regulatory authorities, partners, and key opinion leaders, and explain statistical issues clearly to people who are not statisticians.
• Expand the department's methodological range. Bring in approaches we are not using yet, and make the case for when they add value.

What we are looking for

• A candidate with a comprehensive statistical toolkit coupled with the judgment to select the appropriate method for each problem. You are as comfortable proposing an approach as executing one.
• Someone with a holistic view, comfortable when a question is still taking shape. You see how a design choice early on shapes what can be claimed later.
• 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.
• The confidence to challenge constructively, identifying when a plan will not meet stakeholder needs and proposing more effective alternatives; values rigorous discussion as much as the final decision.
• Curiosity about where the field is going, and a view on which new methods and tools are worth adopting. You bring colleagues along with you.
• Good knowledge of SAS programming. Familiarity with R or Python is an advantage.
• Strong communication skills. You can explain a statistical issue to a clinician, a regulator, and a project team, and be understood by all three.
• The ability to work independently, hold several priorities to timelines, and work across functions.

You have a solid theoretical background in mathematical statistics, at minimum MSc level or equivalent, and at least 10 years of experience in clinical development within the pharmaceutical industry. You know the statistical regulatory guidelines well. Insight into pharmacokinetics and pharmacodynamics is an advantage. Experience in allergy, immunology, or respiratory is a plus, but the ability to get up to speed in a therapeutic area matters more than already being there.

Become a part of ALK

ALK is a global pharmaceutical company specialised in allergy immunotherapy. We provide an attractive working environment for individuals looking for both personal and professional development. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with our colleagues.

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.