Description
Project Statistician / Data Manager (flexible level of seniority according to experience)The Project Statistician / Data manager will be an active member of internal Prosensa project teams, for which any pre-clinical or clinical studies are on-going and will give statistical input on study designs and analytical techniques for these studies.
Management of outsourced activities for Biometrics (data management and statistics).The role will involve facilitating that Prosensa study data is retrieved from vendors in a suitable format for partnership deals with other companies or regulatory filing.
General
- Act as Statistics and Data Management representative for cross-functional teams
- Generation of statistical output for internal review teams
Provides statistical support to other disciplines related to statistics as directed by line manager
Job responsibilities
- Assists in the oversight of the design of clinical databases and case record forms (paper and electronic)
- Advise and contribute to the methodological and statistical aspects of clinical trials and protocols
- Reviews and signs off statistical analysis plans and other statistical documentation generated by vendors
- Manage and review statistical and data management documentation produced by vendors for individual studies.
- Oversees development of statistical analysis, tables and data listings generated by CROs
Statistical input to study reports
Job requirements
- MSc degree in medical statistics
- Good/ advanced knowledge of SAS programming
- Comprehensive working knowledge of statistical methodology
- 5 yrs+ experience working as a medical statistician in drug development
- Experience and knowledge of management of the data management process
Experience of outsourcing of Biometrics aspects of studies
- Organisational and written/oral communication skills
- Team player
- Good attention to detail
- Able to work Independently
All applicants must be fluent in English (verbal & written)
To find out more about Real please visit www.realstaffing.com