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, 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). 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 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 Share relevant knowledge and experiences with the colleagues in internal meetings and provide instructions to more junior statisticians 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 PhD or MSc degree in Statistics Capability to provide statistical leadership to cross-functional teams at a project/study level The ability to investigate data and suggest appropriate analysis to aid cross-funcational decision making Good knowledge of international standards for data collection (CDISC)



Proficiency in using SAS System to conduct analysis Including study design and statistical analysis approaches typically used in small population trials Experience applying adaptive design and/or Bayesian approaches to study design and analysis Europe - Remote Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process.

The budgeted salary range approved for this role is between €59.000 and €74.000. This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, adaptable benefits programme, and more.

Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.

Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws.

📌 Medical Statistician (Madrid)
🏢 Chiesi Group
📍 Madrid