Biostatistician - Vascutek Ltd - Glasgow - Inchinnan

Vascutek Ltd

Position Description

Vascutek require a skilled individual to provide statistical and data management support to clinical study teams based in Glasgow and the US. 

Key responsibilities and duties will include but not be limited to; 

• Undertake administrative tasks to assist the Clinical Affairs Department with Clinical Trial and Post Market Surveillance (PMS) activities. 
• Undertake training to develop competency in compliance with ICH GCP, the Medical Device Directive, ISO 14155, internal procedural documents and any other relevant regulatory requirements. 
• Collaborates in the process of study protocol development by calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol. 
• Write and review Statistical Analysis Plans (SAPs) based on study protocols 
• Develop tables, listings, and figures. 
• Create programming specifications for analysing datasets and generating tables, listings, and figures. 
• Provide quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP. 
• Ensures proper study closeout by documenting and archiving study related materials. 
• Provides training and advice on statistical methodology to other departments or members of the clinical affairs/research team.

Required Experience

Skills and experience required; 

• Bachelor’s degree in statistics or mathematics with a background in clinical medicine or clinical research.
• Demonstrable experience in a clinical research environment. 
• Experience in SAS programming.
• Excellent knowledge of statistical theory including experimental design, categorical data analysis, analysis of variance (covariance), survival analysis, and non-parametric methods 
• Effective written and verbal communication skills. 
• Be able to work simultaneously across multiple projects. 

Desirable experience; 

• MS or PhD in Biostatistics or related field. 
• Experience of medical device trials.
• Experience of participating in the preparation of annual reports and/or Final Study Reports for FDA.
• Working knowledge of Good Clinical Practices, Clinical trial process and related regulatory requirements and terminology. 

Salary and Benefits

Full Time, Permanent 
Clinical Affairs Department - Reports directly to the Head of Clinical Research 
Salary: ££Excellent plus benefits