About usChiesi 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.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 trials acquired within pharmaceutical companies or CROsStrong knowledge of drug development process and regulatory requirements (such as ICH/GCP)Strong statistical methodology knowledge with application to drug development and clinical trialsCapability to provide statistical leadership to cross-functional teams at a project/study levelStrong communication skills with the ability to communicate complex statistical concepts to a non-statistical audienceThe ability to investigate data and suggest appropriate analysis to aid cross-funcational decision makingGood knowledge of international standards for data collection (CDISC)Proficiency in using SAS System to conduct analysisKnowledge of tools for sample size calculationEnglish fluentWe would prefer for you to haveExperience in clinical trials for rare diseases. Including study design and statistical analysis approaches typically used in small population trialsExperience applying adaptive design and/or Bayesian approaches to study design and analysisExperience in interactions with Regulatory Agencies, researchers, health careExperience with studies across all phases of clinical developmentKnowledge of R or other statistical programming languagesLocationEurope - RemoteCompensation RangeThe package outlined below is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, premio 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 minimum salary for this role is 59.000, aligned to our established salary framework. The final offer will reflect the candidate's skills, experience, qualifications and internal equity considerations.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, flexible benefits programme, and more.What we offerNo matter where your path starts at Chiesi, it leads to inspiring possibilities. 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.Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. 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. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.

📌 Principal Statistician, Global Rare Diseases (Vicofertile)
🏢 Chiesi
📍 Vicofertile