Ballerup, Denmark
Posted by: Leo Pharma
05 Dec

Senior Principal Biostatistician

Ballerup, Denmark
Job Description

LEO Pharma has set the ambitious goal to become a world leader in medical dermatology. We want to offer the most diverse range of treatment solutions. As Senior Principal Biostatistician you will become a key player in making our vision come true. 

Your new team 
You will join the Biostatistics department, a team of 20 biostatisticians at the LEO Pharma headquarters in Ballerup, Greater Copenhagen. You can look forward to joining a team that is diverse and very well-functioning. We work in a good and informal atmosphere characterized by helpfulness and a common drive for breaking new land. 

Your role 
Your overall objective is to be the statistical lead on one or more clinical development programs - ensuring the scientific integrity and quality of all statistical aspects of the program. You can look forward to sharing knowledge and collaborating with other experts across clinical development. 

Your primary tasks will be to: 

• Provide the statistical input and perspective to the development plans and discussions in the projects. 
• Regulatory interaction: Be responsible for the statistical parts in regulatory interactions e.g. pre-IND meetings, IND submissions, EoP2 meetings, pre-NDA meetings, NDA and MAA submissions. 
• Act as mentor for junior staff. 
• Contribute to generation of and be responsible for the scientific statistical integrity of clinical development plans, trial outlines, clinical trial protocols, clinical regulatory documents, project outlines and similar documents. Contribution to publications. 
• Take initiative to gather scientific knowledge/advice from external parties. 
• Teaching or presenting to relevant LEO staff on seminars, internal courses, or other meetings (including investigator meetings) as required. 

Additionally, you will get the opportunity to impact our efforts to continuously improve the department's procedures and optimization of best practices. 

Job ID Reference
Desired Skills & Experience

You have a solid theoretical statistical background e.g. M.Sc. or PhD in statistics, mathematics, computing, or engineering. This is backed by +10 years of professional experience in statistics applied to clinical development. 
Your success will, to a wide extent, be founded within your ability to create results via collaboration with many different people across multiple areas of expertise. This takes an open-minded and positive approach as well as respect and curiosity, and you are driven by innovation, results and strategic business needs. 

Additionally, you must be able to communicate effectively your results, conclusions and recommendations in a way that is understandable to people without your personal expertise, in written and spoken English. 

  New York
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have an ambitious 2025 strategy, which aims to accelerate our impact in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma´s vision is to reach 125 mill. patients worldwide by 2025. Our nimble and entrepreneurial environment allows passionate people to innovate and make a visible impact.
 Ballerup, Denmark