Principal Statistician, Global Rare Diseases

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Principal Statistician, Global Rare Diseases Date: 29 Jul ****
Department: GRD Clinical Development
Business Area: R&D;, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type: Permanent
Location: Parma, IT
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.
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 Vantaggi 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 for This 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 ***** 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 Statistics
A significant (>10 years) experience in statistics applied to clinical trials acquired within pharmaceutical companies or CROs
Strong knowledge of drug development process and regulatory requirements (such as ICH/GCP)
Strong statistical methodology knowledge with application to drug development and clinical trials
Capability to provide statistical leadership to cross-functional teams at a project/study level




Strong communication skills with the ability to communicate complex statistical concepts to a non-statistical audience
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
Knowledge of tools for sample size calculation
We would prefer for you to have Experience in clinical trials for rare diseases. 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
Experience in interactions with Regulatory Agencies, researchers, health care
Experience with studies across all phases of clinical development
Knowledge of R or other statistical programming languages
Location Europe - Remote
Compensation Range The 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.
The minimum salary for this role is € ******, 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.
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.
What we offer No 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.
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.
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79anur