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Senior Principal Biostatistician  

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Posted on : 08 May 2017

Project Description

Senior Principal Biostatistician

Would you like to play a key role in the development of our growing portfolio - and are you an experienced Biostatistician - then the opportunity is here.

LEO Pharma is committed to improving the lives of people with skin diseases around the world. With our ambitious aspiration to help more than 100 million people by 2020, LEO Pharma is looking at new and innovative solutions - now also entering into development of biologic treatments. LEO Pharma is set to become the world dermatology leader – offering the most diverse range of treatment solutions to meet the individual needs of people with skin diseases.

We are in Biometrics, LEO Pharma looking for a Senior Principal Statistician for a Biostatistics Lead role. The responsibility of a Biostatistics Lead is to be part of the strategic planning of our development projects, and to ensure planning and execution of required activities in collaboration with relevant colleagues in R&D. As a Biostatistics Lead you are an important link between our project organisation and our departments in R&D.

Your primary assignments  

  • Member of a cross functional Portfolio team, responsible for the overall strategic planning within a disease/portfolio area
  • Provide statistical advice to Portfolio/Project teams, management and to other scientists within R&D
  • Ensure data alignment across projects within a disease/portfolio area
  • Participate in authority interaction, both written correspondence as well as face to face meetings
  • Ensure quality of data for external communication (publications, abstracts, posters)
  • Responsible for integration between the project organisation and relevant line organisations
  • Provide statistical input to documents supporting strategic planning of development projects: Project Business Plans, Target Product Profile/Claim, Clinical Development Plans, Clinical trial designs, Pediatric Investigational Plans
  • Approve documents supporting clinical development: Clinical Trial Protocols, Statistical Analysis Plans, Clinical Trial Reports, submission documents
  • Provide statistical input to Due Diligence projects
  • Participate in Ad Board/KOL interactions
  • Collaborate closely with project statisticians, trial statisticians and programmers from the Biometrics Department as well as many other experts and colleagues from R&D with focus on clinical development
  • Participate in the continuous improvement of the Biometrics department’s procedures and secure best practices

 

Your competency profile

You must possess the following qualifications:

  • Appropriate theoretical statistical background e.g. M.Sc. or PhD in statistics
  • Experience from working with clinical development  project
  • Relevant clinical and pharmaceutical industry experience in the planning and conduct of clinical trials
  • NDA/MAA submission experience
  • Be a team player who is able to work with other scientists from different functional areas and simultaneously has the ability to work and think independently
  • You take responsibility, are structured, committed, flexible and have a positive attitude
  • You possess good communication skills in English, verbally as well as in writing

Are you ready to join us?

Biometrics is part of GCO, R&D and consists of Biostatistics, Medical Communication, Data Management and Biostatistics Leads. You will report to the Director of Biometrics and as part of the extended Biometrics Management Team you will be involved in the continuous development and improvement of the Biometrics area within LEO Pharma. 

We offer a challenging job as Biostatistics Lead, where you in close collaboration with the other members of the Portfolio team will be part of setting the strategy for our development projects. You will be working together with competent colleagues across LEO including medical experts, regulatory professionals and commercial, and you will be collaborating with other qualified statisticians and statistical programmers from Biostatistics.

You will have the opportunity to attend relevant workshops/congresses in order to develop your skills as pharmaceutical biostatistician.

We offer a challenging job in a global environment and aim to offer a competitive package. Furthermore you will get the opportunity to contribute and be part of a flexible, pleasant and busy working environment in a well-run and informal department.

We look forward to welcoming you to our team!