Good morning Allstat

 

I am working on an exciting opportunity with a small pharmaceutical company located in Stockholm, Sweden.

 

My client is looking for a talented Statistician to lead the development and statistical interpretation of a pivotal study in rare diseases.

 

 

This is a fantastic opportunity for someone who wishes to be a principal part of the development process within a small and collaborative team.

 

 

Director, Biostatistics and Data Management

Stockholm, Sweden – relocation provided

Very competitive salary plus benefits

 

 

Key information

 

• Biostatistics lead for the BLA: preparation, review and finalisation of filing documents
• Review the available data from completed studies and ensure the internal database is built to comply with regulatory standards
• Collaborate with Medical/Clinical Development function in the generation of evidence from completed and ongoing interventional studies, and external collaborations on natural history studies and registries
• Support Publication Plan with data generation and interpretation

 

 

Key requirements

 

• Biostatistics industry experience in support of Clinical Development and Medical Affairs function
• Experience (ideally both FDA and EMA) in preparing regulatory documents and participation in regulatory interactions
• Expertise in Data Management and experience in building data structures in formats accepted by regulatory agencies
• English proficiency to write and communicate at a high, professional level

 

 

Please get in touch for further information via telephone on +44 1438 768713 or via email on [log in to unmask]

 

Thank-you

 

 

 

Kind regards,

 

Stephanie Maccioni Cert RP MIRP
Biometrics Recruitment Consultant II

 

CK Group
Richmond House

Walkern Road

Stevenage

Hertfordshire

SG1 3QP

DD: 01438 768 713    I    Tel: 01438 743 047    I    www.ckclinical.co.uk

 

Linked In: https://uk.linkedin.com/in/stephanie-maccioni-certrp-794161b0

 

CK Clinical, CK Science, CK Engineers and CK IT are trade names of CK Associates Limited

For more information visit: www.ckagroup.co.uk

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CK Group is the trading name of CK Associates Limited. Registered in England No 2611749

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