Biostatistician with a flair for big data

Would you like to help us create our new Biostatistics function and set the stage for the assessment of medicinal products and clinical trials? Would you be interested in working with a European Big Data strategy and providing high-level scientific advice? And would you like to play a part in setting the European agenda for the licensing of medicines - with special focus on data, analysis and statistical methods? 
 
Then come and join us at the Danish Medicines Agency! 
 
The Danish Medicines Agency has a vision 
The Danish Medicines Agency is Denmark’s national regulatory authority for the licensing and monitoring of medicinal products, medical devices and clinical trials. Our mission is effective, safe and accessible medicines and safe medical devices that benefit society. 
 
We are around 400 employees based in Copenhagen and through the European Medicines Agency (EMA) we collaborate with our colleagues from the other European drug regulatory authorities. We participate in various professional working parties with other experts, and Denmark has a seat on all the European committees for medicinal products. 
 
Our vision is to become one of the leading drug regulatory authorities in Europe. This means that we want to be a key driver of European collaboration, obtain a strong international position and help boost Denmark a leading life science nation. 
 
The Danish Medicines Agency offers a multidisciplinary workplace 
The position is located in the Biostatistics function in our new Medical Evaluation & Biostatistics division. In this division, we will gather our medical resources from the licensing and pharmacovigilance divisions. The new Biostatistics function will strengthen our biostatistics efforts and establish an efficient data-analytical environment. The function will cooperate with all the relevant groups of the organisation. 
 
Your profile 
You have a relevant master’s degree in mathematics/statistics or equivalent master’s degree in natural science. Research experience from e.g. a PhD programme is desired. You have work experience in statistical analysis from the pharmaceutical industry or a strong research environment. Your professional expertise is essential. 
 
To apply for the position, you need to: 

• have an interest in and a flair for assessing clinical research and preferably experience in designing various types of clinical trials (phase I, II and III trials) 
• have a flair for big data 
• be able to combine and balance details with being pragmatic 
• have excellent interpersonal skills, stay focused, maintain strong attention to detail and meet deadlines  
• be motivated by working in an multidisciplinary and international environment where English is the working language, and you speak and write English proficiently. 

 
What we offer 
An international workplace with collaboration partners throughout Europe via the European Medicines Agency. In the longer term, you will get the opportunity to participate in the EMA’s working parties. 
 
You will become part of a dynamic and professional environment with competent and energetic colleagues, and you will be offered supplementary and further training within relevant areas. We offer an informal working environment characterised by dedication, humour and mutual respect. 
 
You will have challenging and varied work tasks, and you will be using and developing your competencies within a wide range of tasks. You will be offered an individual development programme tailored to your needs so that you can improve and develop your competencies. 
 
In the start-up phase, the Biostatistics function will have four scientific employees, and you will get the opportunity to increase your experience in the assessment of study designs and clinical data and get thorough knowledge of regulatory requirements for the licensing of medicines. We want to expand our biostatistical expertise, and you will get the chance to leave your mark on this. On an experimental basis, we will start to make statistical analyses of raw data to be able to validate submitted dossiers or clinical study reports. The intention is that our biostatisticians will participate in the EMA collaboration. In addition, you will be heavily involved in a pan-European working group on big data to be headed by the Danish Medicines Agency. 
 
A working day in our Biostatistics function 
You assess clinical data, analyses and statistical methods of a new medicinal product submitted by a pharmaceutical company. They have studied cancer patients, but you don’t quite agree with their interpretation of the results. 
 
You are having a conference call with experts from another EU country who have also assessed the studies or the clinical programme. You have co-authored a report, which all the European countries will be discussing at the next meeting of the European Committee for Medicinal Products for Human use. 
 
You are making preparations for a scientific advice meeting with a company. A pharmaceutical company plans to submit an application for the authorisation of a new medicinal product, but they are unsure whether the planned clinical development project is sufficient. They have obtained advice from the US drug regulatory authority. And now they are paying visits to various drug regulatory authorities in Europe. You provide statistical advice on the study design of their phases IIB and III programme. And you make your own analysis of the data they have submitted. 
 
Conditions of employment   
The position is covered by the terms of the collective agreement between the Danish Ministry of Finance and the Danish Confederation of Professional Associations with the possibility of negotiating qualification supplement. In addition to the salary, a monthly contribution to a pension fund is added (17.1% of the salary).  
 
The position is full time with start on 1 March 2017 or as soon as possible after this date. 
 
Further information   
For more information, please contact Director General Thomas Senderovitz, tel. +45 9359 6479 / +45 4488 9595. 
 
Read more about the Danish Medicines Agency at www.dkma.dk.  
 
Application   
Apply online on by clicking on "Apply" no later than 27 January 2017. The application should include your motivation letter, current CV and copies of relevant diplomas. Interviews are scheduled to be held in weeks 5 and 6.   
  
We encourage all interested candidates to apply, regardless of age, gender, religious affiliation or ethnic background. 

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