Arbejde Senior Principal Biostatistician unspecified LEO PHARMA A/S - jobtilbud

GÆLDER
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reference: 4864715

documentId: 4864715

connectionPointId: 7

lastModificationDate: 1534330390416

stillingsbetegnelse: Senior Principal Biostatistician

jobbeskrivelse:

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 on an exciting journey

LEO Pharma is stronger than ever with a growing global presence, a dedicated work force of more than 5,000 specialists and a strong pipeline of unrivalled pharmaceutical products within dermatology and thrombosis. In 2017, LEO Pharma helped more than 80 million patients, and laid out a new ambitious strategy towards 2025, with a clear direction towards global leadership in medical dermatology, while still continuing our investment in our thrombosis business.
We are in GCO Projects, LEO Pharma looking for an experienced biostatistician for a Biostatistics Lead role. 
GCO Projects is part of Global Clinical Operations, Research & Development. All Biometrics functions is in LEO part of Global Clinical Operations. The responsibility of a Biostatistics Lead is to contribute to the strategic planning of our development projects, and to ensure planning and execution of development activities in collaboration with relevant colleagues in Research & Development. As a Biostatistics Lead you are an important link between LEOs project organisation and the departments in Research & Development.

Your primary assignments

  • Member of a cross functional Portfolio/Project 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
  • Review and approve documents supporting clinical development: E.g. 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, and other experts and colleagues from R&D with focus on clinical development
  • Participate in the continuous improvement of the Biometrics department’s procedures, biostatistical competencies and secure best practice

 

Your competence profile

You must possess the following qualifications:

  • Appropriate theoretical statistical background e.g. M.Sc. or PhD in statistics
  • At least 10 years’ experience from working with clinical development projects in the pharmaceutical industry 
  • BLA/NDA/MAA submission experience and preferably also experience with health technology assessment aspects 
  • 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 on 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?

You will report to the Director of GCO Projects. As a Biostatistics Lead you will be working closely together with Research and Development portfolio and project teams. Furthermore you will collaborate closely with colleagues and managers from the Biometrics area in GCO and you will be involved in the continuous development and improvement of GCO and the Biometrics area. 
We offer a challenging job as Biostatistics Lead, where you in close collaboration with the other members of the Portfolio teams and Project teams 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. 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!



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jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2131

abstractJV_contact_0:
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positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR

GÆLDER

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