Job Description & How to Apply Below
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At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Chiesi Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global 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).Who
we are looking forThis is what you will do 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.
You will be responsible for Providing statistical input in support of Drug Development Programs 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
Perform or supervise statistical activities for clinical trials; when activities are outsourced, interact with CROs and other external vendors
Review abstracts, posters, presentations, and manuscripts for publications
Review Clinical Study Reports Collaborate in writing regulatory documents. Manage the statistical deliverables required by eCTD submission
Address any queries on statistical topics from regulatory agencies
Participate in regulatory audits/inspections as required. Attend meetings with regulatory agencies to support drug registration
Review/develop the Statistical Analysis Plan, including review or development of the definition of derived data sets, statistical tables, figures, and data listings for clinical summary reports
Plan, review and conduct high quality statistical analyses, post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies interacting with SAS programmers, as needed
Lead all the statistical activities for the Data Review Meeting or interacts with CRO statistician when activities are outsourced
Supervise and support the operational activities of statistical programmers
Share relevant knowledge and experiences with the colleagues in internal meetings and provide instructions to more junior statisticians
Participate and present, where appropriate, in educational activities
Demonstrate leadership in creation and promotion of an environment of teamwork, clearly communicating the expectations and objectives of the data analysis component of a project
Work as a member of a team to achieve all outcomes
Contribute to definition of Standard Operating Documents, if needed
Perform all work in accordance with established regulatory requirements ensuring compliance with GCP, GCDMP and CFR 21.11 guidelines, maintaining an in-depth knowledge of these documents
Participate in the Chiesi recruitment program as needed
Responsible to ensure compliance with Safety and Employment policies (e.g., Respect in the Workplace
- Prevention of Violence and/or Harassment)
You will need to have
PhD or MSc degree in StatisticsA significant (10 years) experience in statistics applied to clinical trials acquired within pharmaceutical companies or CROsStrong knowledge of drug development process and regulatory requirements (such as ICH/GCP)
Strong statistical…
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