Senior Biostatistician

Would you like to help us develop our 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 a focus on data, analysis and statistical methods?  

Then come 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: “Effective, safe and accessible medicines and safe medical devices that benefit society”.

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 as a leading life science nation.

We are around 450 employees based in Copenhagen and through the European Medicines Agency (EMA) we collaborate with our colleagues from the other European drug regulatory authorities. Denmark has a seat on all the European committees for medicinal products and we participate in professional, international working parties together with experts from the other European countries.

The Danish Medicines Agency offers a multidisciplinary workplace  

The position is based in the Biostatistics function in our Medical Evaluation & Biostatistics division. This division contains the collective medical resources of the Danish Medicines Agency within licensing and pharmacovigilance. The Biostatistics function is set out to strengthen our biostatistics efforts and establish an efficient data-analytical environment. The function cooperates with all the relevant groups of the organisation.  

Your profile  

You have a relevant master’s degree in statistics/mathematics or equivalent master’s degree in natural science. Research experience from e.g. a PhD programme is desired. You have considerable work experience in statistical analysis from the pharmaceutical industry or a strong research environment. Your professional expertise is essential. You are highly proficient in spoken and written English.

In addition, it is important that you wish to enhance and further develop the quantitative data capabilities of the Danish Medicines Agency. We experience an increased demand for data analysis, also after approval. It is an advantage, if you have experience and interest in Real World Evidence and post approval data analysis. You possess an entrepreneurial mindset and you are motivated to develop the Biostatistics function. The Biostatistics function is in its beginning, with significant perspectives for the development of the function and for your career.

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 a multidisciplinary and international environment where English is the working language, and you speak and write English proficiently.
  • possess relevant line- or project management experience establishing new functions.

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 conducted a trial in cancer patients, but you don’t quite agree with their interpretation of the results.

You have a conference call with experts from another EU country who, like you, have assessed a given study or clinical programme.

As co-author, you write parts of the contents of 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 make preparations for a Scientific Advice meeting with a company. This 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.

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 working parties.

You will become part of a dynamic and professional environment with skilled and diligent 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 skills.

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 have 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 can be involved in a European working group on big data to be headed by the Danish Medicines Agency.

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).

Further information  

For more information, please contact Biostatistician Aldana Rosso tel. +45 9351 8634, Head of Department – Cancer Diseases, CMO Doris Hovgaard, tel. +45 9359 0156 or Director of Division – Medical Evaluation & Biostatistics, CMO Nikolai Brun, tel. +45 25 26 52 88.

 

You can also contact Peter Halken (+45 2711 4080) or Torkild Skovsgård (+45 2012 4890) from the consultancy company Halken Partners, who is assisting the Danish Medicines Agency in this recruitment.

 

Read more about the Danish Medicines Agency at www.dkma.dk

 

Application  

Youapply to the position here: https://candidate.hr-manager.net/ApplicationForm/SinglePageApplicationForm.aspx?cid=5001&departmentId=9110&ProjectId=118165&MediaId=5

The application should include your motivation letter, current CV and copies of relevant diplomas.

Interviews are scheduled to be held in week 2-3.

 

From January 1st 2018, The Danish Medicines Agency have non-smoking working hours.

We encourage everyone who are interested to apply to the position – regardless of age, gender, religion, disabilities or ethnicity.

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