Principal Statistician, Global Rare Diseases

About us
Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

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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 & DevelopmentOur 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 doProvide 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 forProviding statistical input in support of Drug Development ProgramsWorking with the other functions in assessing and leveraging data for meaningful, fit-for purpose summarizationProvide statistical support and leadership for study design, sample size calculation, patient randomization, statistical methods and analyses, analysis, and interpretation of data, reporting of resultsPerform or supervise statistical activities for clinical trials; when activities are outsourced, interact with CROs and other external vendorsReview abstracts, posters, presentations, and manuscripts for publicationsReview Clinical Study ReportsCollaborate in writing regulatory documents.

Manage the statistical deliverables required by eCTD submissionAddress any queries on statistical topics from regulatory agenciesParticipate in regulatory audits/inspections as required.

Attend meetings with regulatory agencies to support drug registrationReview/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 reportsPlan, review and conduct high quality statistical analyses, post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies interacting with SAS programmers, as neededLead all the statistical activities for the Data Review Meeting or interacts with CRO statistician when activities are outsourcedSupervise and support the operational activities of statistical programmersShare relevant knowledge and experiences with the colleagues in internal meetings and provide instructions to more junior statisticiansParticipate and present, where appropriate, in educational activitiesDemonstrate leadership in creation and promotion of an environment of teamwork, clearly communicating the expectations and objectives of the data analysis component of a projectWork as a member of a team to achieve all outcomesContribute to definition of Standard Operating Documents, if neededPerform 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 documentsParticipate in the Chiesi recruitment program as neededResponsible to ensure compliance with Safety and Employment policies (e.g., Respect in the Workplace
- Prevention of Violence and/or Harassment)You will need to havePhD or MSc degree in StatisticsA significant (>10 years) experience in statistics applied to clinical tr