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Statistical Modeller Clinical Trials Data

South East, United Kingdom, £ £ 45000.00-78000.00 Annual Annual, Contract


Statistical Modeller (Clinical Trials Data) c£45-78k
South Ref: ABJ5271
(One year maternity cover TEMP contract)
Approx £(Apply online only) a day ltd dependent on experience
An experienced Statistical Modeller with experience in statistical modelling you will work closely with the Data team to provide support across the business in terms of computational modelling, data standards, experimental design and statistical analysis.
As a Statistical Modeller you will be crucial in helping to deliver the scientific evidence to demonstrate risk status for products in support of regulatory acceptance for US regulations.
The group has been leading in the development of the scientific efficacy assessment of compounds and this programme supports regulatory engagement, compliance and new product categories. As a statistical modeller you would be using data from pre-clinical and clinical studies to substantiate claims and to pass to regulatory submissions teams to help product launches and establishing partnerships and collaborations to develop new capabilities to enhance science delivery.
Key Responsibilities
* Leading activities for development, maintenance and implementation of internal data standards and processes to ensure efficiency and traceability of data.
* Support predictive modelling work programs Involving collation/curation of data, model translation and code development.
* Providing statistical analysis and experimental design support.
* Contribute to data review and preparation to meet claims requirements and for regulatory submissions
* Support project development with regards to study design, analysis and data management to ensure consistency and traceability
* SAS programming to support above tasks
* Providing data management and data review support for clinical studies
* Data checking and reviewing to support team members
Qualifications and Experience
* BSc MSc or PhD with a scientific field with a strong statistical content - (Mathematics/Computing, Statistics/Computing)
* Experience in statistical modelling using trials data.
* Solid grounding in the application of statistical methods and data analysis
* Experience in Pre-Clinical, Clinical, Non-Clinical Human Studies and Analytics (desirable)
* Experience in Design of Experiments, regression modelling and data manipulation
* Good to have working knowledge of data standards principles with emphasis on CDISC (STDM / ADaM)
* Proficient in SAS Base Programming (additional statistical software packages e.g. Minitab/JMP, R, Python)
* Proactive; self-driven with strong interpersonal, organizational, and multi-tasking skills.
* Experience with FDA regulatory submissions (desirable)
To Apply: Please contact Alison Basson at Hudson Shribman Scientific Recruitment, Please call

Job Details

Not Specified
South East, United Kingdom
£ £ 45000.00-78000.00 Annual Annual