03 oct
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Chiesi Group
|
La Mancha
03 oct
Chiesi Group
La Mancha
Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. Chiesi Research & Development
It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, general technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D; project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).
Provide statistical expertise and contributions for projects and protocols in support of Drug Development Programs; to provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables; to provide/oversee statistical support to planning, preparation, review and interpretation of data for clinical trials (interventional, observational and registries studies), ensuring that data are analysed and evaluated with appropriate statistical methodologies.
Working with the other functions in assessing and leveraging data for meaningful, fit-for purpose summarization
Provide statistical support and leadership for study design, sample size calculation, patient randomization, statistical methods and analyses, analysis, and interpretation of data, reporting of results
when activities are outsourced, interact with CROs and other external vendors
Collaborate in writing regulatory documents. Review/develop the Statistical Analysis Plan, including review or development of
📌 Statistician Trainee (La Mancha)
🏢 Chiesi Group
📍 La Mancha