ppSelect how often (in days) to receive an alert: /p h3Principal Statistician, Global Rare Diseases /h3 pDate: 29 Jul 2026 /p pDepartment: GRD Clinical Development /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p h3About us /h3 pChiesi 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. /p pAt 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 Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /p pDiversity 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. /p h3Chiesi Research Development /h3 pOur RD 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, RD 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). /p h3Who we are looking for /h3 h3This is what you will do /h3 pProvide 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. /p h3You will be responsible for /h3 ul liProviding statistical input in support of Drug Development Programs /li liWorking with the other functions in assessing and leveraging data for meaningful, fit-for purpose summarization /li liProvide statistical support and leadership for study design, sample size calculation, patient randomization, statistical methods and analyses, analysis, and interpretation of data,



reporting of results /li liPerform or supervise statistical activities for clinical trials; when activities are outsourced, interact with CROs and other external vendors /li liReview abstracts, posters, presentations, and manuscripts for publications /li liReview Clinical Study Reports /li liCollaborate in writing regulatory documents. Manage the statistical deliverables required by eCTD submission /li liAddress any queries on statistical topics from regulatory agencies /li liParticipate in regulatory audits/inspections as required. Attend meetings with regulatory agencies to support drug registration /li liReview/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 /li liPlan, review and conduct high quality statistical analyses, post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies interacting with SAS programmers, as needed /li liLead all the statistical activities for the Data Review Meeting or interacts with CRO statistician when activities are outsourced /li liSupervise and support the operational activities of statistical programmers /li liShare relevant knowledge and experiences with the colleagues in internal meetings and provide instructions to more junior statisticians /li liParticipate and present, where appropriate, in educational activities /li liDemonstrate leadership in creation and promotion of an environment of teamwork, clearly communicating the expectations and objectives of the data analysis component of a project /li liWork as a member of a team to achieve all outcomes /li liContribute to definition of Standard Operating Documents, if needed /li liPerform 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 /li liParticipate in the Chiesi recruitment program as needed /li liResponsible to ensure compliance with Safety and Employment policies (e.g., Respect in the Workplace - Prevention of Violence and/or Harassment) /li /ul h3You will need to have /h3 ul liPhD or MSc degree in Statistics /li liA significant (10 years) experience in statistics applied to clinical trials acquired within pharmaceutical companies or CROs /li liStrong knowledge of drug development process and regulatory requirements (such as ICH/GCP)



/li liStrong statistical methodology knowledge with application to drug development and clinical trials /li liCapability to provide statistical leadership to cross-functional teams at a project/study level /li liStrong communication skills with the ability to communicate complex statistical concepts to a non-statistical audience /li liThe ability to investigate data and suggest appropriate analysis to aid cross-funcational decision making /li liGood knowledge of international standards for data collection (CDISC) /li liProficiency in using SAS System to conduct analysis /li liKnowledge of tools for sample size calculation /li /ul h3We would prefer for you to have /h3 ul liExperience in clinical trials for rare diseases. Including study design and statistical analysis approaches typically used in small population trials /li liExperience applying adaptive design and/or Bayesian approaches to study design and analysis /li liExperience in interactions with Regulatory Agencies, researchers, health care /li liExperience with studies across all phases of clinical development /li liKnowledge of R or other statistical programming languages /li /ul h3Location /h3 pEurope - Remote /p h3Compensation Range /h3 pThe package outlined below is based on the role being located in Italy. 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. /p pThe 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. /p ul liThis role is eligible to participate in an annual bonus scheme, subject to company and individual performance. /li liIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme, and more. /li liWe 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. /li /ul h3What we offer /h3 pNo 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. /p pChiesi 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. /p /p #J-18808-Ljbffr

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