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Biostatistician with experience in clinical drug development

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Do you have a passion for Biostatistics? Do you want to be involved in approval and surveillance of novel and advanced therapeutics? Do you want to use your knowledge for the benefit of patients throughout Europe? Do you want to join a recently established biostatistics function at The Danish Medicines Agency? Do you have experience and interest in working with large and complex data sets from a variety of sources? Then a job at the Danish Medicines Agency (DKMA) might be just what your next career move should be.  
 
About the Danish Medicines Agency (DKMA)  
We are the national authority for approval and surveillance of medicines and devices based in the heart of Copenhagen. About 450 employees perform tasks on a daily basis both on a national level and on behalf of the European Union. We participate actively in Committees and Working Parties at the European Medicines Agency (EMA)  
 
The position is anchored in the division for medical evaluation and biostatistics, which encompasses all quantitative and medical (human and veterinary) evaluation across the agency. We give input to all functions in the agency such as drug approvals and pharmacovigilance as well as devices and scientific advice.  
 
We have recently announced a Data Analytics Centre to be built within the frame of the DKMA. The Biostatisticians will perform analytical tasks on behalf of the center dealing with Raw Data analysis, as well as analysis of Real World Data in all formats from a variety of data sources.  
 
A typical 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 program. 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 authorization 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 program. And you make your own analysis of the data they have submitted.  
 
Your experience and profile  
As an ideal candidate you have relevant training in Natural sciences with extensive work experience as a biostatistician. Furthermore you have experience from biotech or the pharmaceutical industry or a strong research experience in phase 2 and 3 studies is highly appreciated. Big Data and advanced analytics are areas of particular interest that you will have the opportunity to work with.  
 
We expect you to be:  
• Fluent in English both spoken and written. Knowledge of a Scandinavian language is beneficial  
• Be able to work in a high-paced international environment with many stakeholders and tight timelines.  
 
Pragmatism and an ability to juggle many tasks while ensuring the highest standards for statistical evaluation is essential.  
 
You will be part of a diverse and ambitious environment with many different competencies. You will find commitment, humor, respect and dedication in some highly skilled colleagues.  
 
We aim to challenge and develop all employees to ensure their competencies are up to date and continuously strengthened.  

Click here for further details and to apply.