- Experience Level
- Experienced (non-manager)
AL Solutions’ client is UK-based Biotech company with experience and focus on research within the Immunology. This dynamic biotech company have a well-established commercial presence in Europe and the US.
Reporting into the Head of Clinical Sciences, the candidate will manage and co-ordinate all activities relating to statistical planning, programming, analysis and reporting to support the R&D projects within clinical studies.
- Act as a lead statistician for multiple projects within Immunology
- Responsible for all statistical aspects of clinical trials including trial design, programming as well as the analysis and regulatory filing strategy
- Programming and validating Analysis datasets, TLFs and statistical analyses for Study reports
- Act as the primary contact with CRO/Vendors for all biostatistics related activities on assigned projects.
- Author and/or review Statistical Analysis Plans (SAPs) centred around the protocols, including development of TFL’s (Table, Figures & Listings) for clinical study reports
- Represent the statistics team for internal and external meetings
- Liaising with internal and external key stakeholders
- MSc or PhD in Statistics or equivalent
- 4+ years relevant experience within the pharmaceutical/biotech industry preferred
- Comprehensive knowledge of statistical theory and methods
- Demonstrated knowledge of all relevant statistical regulatory guidance and standards (e.g.,
- ICH and EMA).
- Experience with modelling and simulation and Bayesian statistical techniques is an advantage
Fatlum Topallaj || Delivery Associate || AL Solutions
firstname.lastname@example.org || 0203 778 0919
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