An international Contract Research Organisation is looking for an experienced and enthusiastic Principal Statistician to support their growing team of statisticians and programmers in Italy. This company provides services for the development of new drugs and medical devices. If you are looking to enhance the quality of life for millions of people, then this might be the life changing role for you.
- Performs and leads the statistical analysis of a clinical study in compliance with the analysis plan and protocol
- Provide high quality statistical support directly to our clients whilst managing projects
- Provides statistical and methodological input for sample size calculation and protocol development
- Leads quality control and senior review of the tables, listings, figures, datasets, inferential analysis and statistical text to ensure compliance with the protocol and SAP
- Leads Data Review Meetings, including coordination of preparations and production of meeting report
- Writes statistical reports and/or sections for the integrated study report, reviews the draft study report, and ensures that all data presented is correct
- Files all datasets, computer programs and other material used in the preparation of the tables, listings, figures, statistical analyses and statistical text for the integrated study report in order to have a complete and transparent documentation of the whole process
- When managing projects, understands project scope, efficiencies, milestones and budgets, ensures the project team understand project scope and minimize issues that impact on the project team, whilst ensuring tasks are appropriately delegated
- Contribute to the development, implementation and maintenance of the quality system for biometrics in general and biostatistics in specific, including process improvements and standards
Skills and Requirements
- Advanced Degree in sciences, with substantial statistics component
- Significant experience as a statistician in life science/pharmaceutical/CRO environment
- Proven organizational and problem solving/decision making skills
- Expert knowledge of the applicable regulatory guidance
- Proficient in SAS software
- Proficient in Microsoft Office (e.g. Word, Excel, Outlook)
- Fluent in English and local language(s)
- Good communication skills
- Advantageous, project management and leadership skills
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have questions, please contact Emma Adams at 0203 854 3893 or upload your CV on our website - www.proclinical.com
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.