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Expert Statistician Supporting Clinical Projects Globally - Denmark  

Company managed [?] Still accepting applications
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Posted on : 10 April 2017

Project Description


Job Description
  • Do you possess expert bio statistical competences and do you enjoy teaching, knowledge sharing and process optimization?  You may be our new expert statistician.
  • In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. 
  • We ensure medical and scientific documentation for clinical submissions and authorities while ensuring that the process lives up to uniform global standards, regulations and business ethics.



About the department
  • The biostatistics function currently consists of 230 statisticians and statistical programmers worldwide. 
  • The position is based in Biostatistics Anchor which is a team of eleven including four statisticians supporting the global biostatistics function as statistical experts. 


The position
  • You will support statisticians in the clinical projects by providing expert advice on complex statistical challenges across all phases of clinical development, i.e. from phase 1 to New Drug Application (NDA) submission and price negotiations.
  •  Based on your continuous update of your knowledge of the view of the regulatory authorities and trends in biostatistics, you will also provide support in interactions with regulatory authorities and external collaborators.
  • Training of statisticians and other professionals is also an important part of the job, both in relation to on-boarding of new colleagues and to ensure that more experienced colleagues are up to date in. You will spend as a minimum 4 weeks per year doing training.
  • You are responsible for review of selected key deliverables within our clinical development process e.g. clinical trial synopses/protocols and result meeting presentations across our clinical projects. 
  • Development of methods and processes, as well as knowledge sharing is continuously on-going in our company.
  • You will be involved in process improvements within Bio statistics and across our Global Development organisation. 
  • You will also take part in development of our internal Bio statistics guideline and you will facilitate the implementation of global standards for analyzing and reporting clinical data. 
  • You must expect to collaborate with many different areas of our company  and both in Denmark and across borders with our colleagues in India, China and Japan, as well as our outsourcing partners around the world.
  • We expect you to take part in our dedicated efforts to make Biostatistics a good and challenging place to work. In exchange we offer great opportunities for on-going training to ensure your continued competency development.



Qualifications
  • You have a solid theoretical background in statistics corresponding to PhD level and at least 10 years of experience with clinical research in the pharmaceutical industry. 
  • You have expert knowledge of bio statistical methods and extensive experience with practical application of bio statistical methodology and statistical software including SAS. 
  • You have experience with the process of drug applications with the FDA and EMA. 
  • Experience with project management and teaching will be considered an advantage. 
  • You are able to handle many assignments concurrently without compromising the quality of your work and you quickly adapt from one therapeutic area to another. 
  • You are a result oriented person with a strategic mind-set, a keen business perspective, personal impact and integrity.
  •  You work independently, and you are proactive with a strong focus on quality and a deep understanding of business needs.  
  • We expect that you remain high spirited, also when things are moving fast. You have excellent collaboration and communication skills. 




Working with Us:
  • We are an organisation with many international employees and we welcome local as well as non-local applicants. 
  • We offer an inspiring and ambitious working environment, alongside the flexibility that allows you to influence your own working day. 
  • We believe that is what stimulates the ingenuity to develop the next generations of cutting-edge treatments.
  • Your skills, dedication and ambition help us change lives for the better.
  •  In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.