One thing we all have in common is the drive to produce great results for our clients and to advance treatment options available to patients worldwide. We always have a desire to keep seeking new and better ways to operate, to achieve these results. 

Leveraging the advantages of working for a top-5 CRO, whilst simultaneously working fully-dedicated to a leading pharma company, will guarantee that the results you help accomplish in drug development are matched by your own career achievements.

Due to growth, PRA currently have a Principal Clinical Data Standards Consultant role available in our Strategic Solutions division. 

Working fully home-based in Europe, you will be fully dedicated to one of our largest Pharmaceutical clients, working within a niche function and a diverse global setting. 

Main responsibilities

• Developing and maintaining SDTM library standards that are used across multiple therapeutic areas. This includes but is not limited to
• CDISC SDTM mapping of data collections and concepts
• Defining and maintaining Data Definition -, Variable Definition-, Value Level -, Where Clause, Methods Metadata,
• Working with MS Excel and SAS and in the future Sycamore’s MDR in development of library standards
• Applies standardized controlled terminology to the SDTM standards
• The scope includes
• Global standards (Cross therapeutic area), Questionnaires and rating scales and disease area specific standards (Therapeutic Area specific)
• Hierarchy of global and therapeutic area specific preconfigured SDTM libraries
• Provide the support to the Therapeutica Area leads who are working directly with the clinical team representatives
• Specifically, process change request to the SDTM library, do the preparation work to expedite CR processing
• Back-up a TA lead providing SDTM mapping and attending cross functional meetings when needed

You are... 

An excellent communicator, a highly experienced Programmer, a multi-tasker

Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support.

To enable success in this position you will have:

• Deep CDISC CDASH and SDTM (specifically SDTM IG 3.2) expertise
• SAS programming knowledge and expertise
• Metadata Standards development (SDTM) expertise

Desirable 

• Cross Therapeutic Area experience
• Global work experience
• SAS LSAF experience
• Therapeutic Area specific SDTM expertise is a plus 
• Experience with biomedical concepts is a plus.

Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.