pSelect how often (in days) to receive an alert: /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: /p pParma, IT /p bAbout us /b 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 Agevolazioni 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 bChiesi Research Development /b 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 h3This is what you will do /h3 pTo provide statistical leadership to clinical drug development and external opportunity evaluation to ensure appropriate statistical methodology is applied to the assigned project(s) /p pTo represent statistics within the Clinical Development Plan (CDP) team, to support other statistician(s) involved in the project, ensuring consistent approach across studies /p pTo ensure statistical activities of the assigned projects are planned/executed according to regulatory requirements, internal standards, project timelines, under budget control /p pTo maximize the value of project data by data-mining, exploratory analysis to support drug development,



hypothesis generation and publications /p h3You will be responsible for /h3 pTo provide scientifically rigorous statistical expertise to clinical development plans, study design statistical analysis, interpretation and communication of statistical results /p ul liResponsible for quality and timelines of all statistical deliverables of the assigned projects / studies including review / approve key statistical vendor deliverables /li liTo share project related information to statistician(s) involved in the project and oversee their activities to ensure consistent approach across studies /li liTo provide statistical input to submission plan, to represent statistics in interacting with regulatory agencies and Health Technology Assessment (HTA) bodies /li liTo write/review regulatory documents (Briefing Books, eCTD modules) /li liTo lead the preparation of all the statistical deliverables required by regulatory submission (ISS, ISE, data package) ensuring compliance with regulatory requirements /li liTo provide statistical input to product evaluation and due diligence /li liTo maximize the value of data by data mining, post-hoc analysis; to write/review abstracts, posters, presentations for publication /li liTo write/review abstracts, posters, presentations for publication /li liTo contribute to development of internal standards and to process definition / improvement, SOPs writing / review /li liTo contribute to internal initiatives, lessons learned and trainings /li liTo represent statistics for auditing / regulatory inspection /li liTo create and maintain collaborative relationship with external Statistical experts and groups KPIs /li /ul h3You will need to have /h3 ul liA significant experience in statistics applied to clinical trials acquired within pharmaceutical companies or CROs /li liPhD or MSc degree in Statistics /li liAdvanced understanding of drug development process and regulatory requirements /li liStrong statistical methodology knowledge with application to drug development /li liStrong experience in regulatory activity (submission preparation and interactions with authority in different geographical areas /li liAbility to explore and analyse internal and external data, including Real World data,



to investigate clinical questions and maximize the product value /li liExperience with products evaluation and due diligence /li liLeadership and social influence /li liQuality orientation /li liProblem solving /li liDecision making /li /ul 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 budgeted salary range approved for this role is between € ****** and € ******.
This range reflects the typical compensation expected for candidates with the experience and expertise required for the position.
/p pFinal offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations.
/p pThis role is eligible to participate in an annual bonus scheme, subject to company and individual performance.
/p pIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme, and more.
/p h3Location /h3 pThe position is preferably based at our headquarters in Parma, Italy, and offers a flexible hybrid working arrangement.
/p pHowever, candidates based elsewhere in Europe will also be considered.
/p bWhat we offer /b 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 pWe 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.
/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.
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📌 Principal Statistician (Parma)
🏢 Chiesi Farmaceutici
📍 Parma