Hello there,
We are looking for an experienced Statistician for this exciting new opportunity.
Job Summary:
This Client is a Market leading, a pioneer within the immunology business with master involvement in the innovative work of sensitivity medicines. Transformational results for patients are accomplished by specifically treating the reason, as opposed to simply overseeing side effects. Their vaccines are aluminium free and our short course treatments make life easier and support adherence.
Requirements:
Adjuvant innovations propel the aftereffects of hypersensitivity immunotherapy but also drive beneficial immune responses in cancer and infectious disease. They are a glad and enthusiastic group of researchers and business pros with a dream that conveys development and changes the way we consider malady.
Job Specific Responsibilities:
* Acts as the responsible for all statistical aspects including trial design, programming, analysis and regulatory filing strategy.
* Collaborates in the process of protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol.
* Lead statistician for multiple projects
* Program and validate Analysis datasets, TLFs for Study reports
* Authors and/or reviews Statistical Analysis Plans (SAPs) based on the protocol, including the development of well-presented mock-up displays for tables, listings, and figures for clinical study reports
* Authors/reviews sections of the clinical study report and publications if needed
* Acts as the primary contact with CRO/Vendors for all biostatistics related activities on assigned projects
* Participates in Data Safety Monitoring Board and/or Data Monitoring Committee activities if needed, and supports charter development.
* Interfaces and closely cooperates with data manager(s)
* Provides data and analytical input to study teams and supports clinical trials to run efficiently by providing accurate and consistent information
* Provides statistical input and support to ATL Regulatory submissions globally and participates in regulatory meetings as needed
Qualifications/Experience required:
* MSc or PhD in Statistics or Medical Statistics degree or equivalent in statistical science, mathematical analysis or related field plus 4-6 years relevant experience
* Comprehensive knowledge of statistical theory and methods and demonstrated ability to apply it to all phases of clinical trials.
* Expertise in SAS programming including statistical analysis, data manipulation and scientific graphing. Other clinical software (e.g. S-plus, R, OCRDC) are desirable
* Demonstrated knowledge of all relevant statistical regulatory guidance and standards (e.g, FDA, ICH and EMA).
* Experience with modelling and simulation and Bayesian statistical techniques is a plus
This is an exciting company and will be a great asset to your profile for your development moving forward.
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