Nine Twenty Engineering are looking for an enthusiastic Biostatistician to join their leading manufacturing client in Renfrewshire.
The successful candidate will provide statistical and data management support to clinical study teams based in both Glasgow and Fort Lauderdale.
Key Duties
- Undertake administrative tasks to assist the Clinical Affairs Department with Clinical Trial and Post Market Surveillance 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.
Essential Requirement
- Bachelor's degree in statistics or mathematics with a background in clinical medicine or clinical research
- 3 years 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
- 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.
If you have the relevant skill set and would like to find out more about this opportunity, please submit your CV for the attention of Nicole Lavelle of Nine Twenty Engineering