Principal Statistician, Global Rare Diseases

Chiesi Farmaceutici S.p.A.; Parma; In loco; EUR 59.000 - 90.000; Tempo pieno

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. is seeking a Principal Statistician for Global Rare Diseases located in Parma, IT.

The role focuses on providing statistical expertise for Drug Development Programs, supporting regulatory submissions, and leading statistics throughout clinical trials, including interactions with CROs. The position requires a PhD or MSc in Statistics with 10+ years in pharma statistics, strong ICH/GCP knowledge, and SAS/CDISC proficiency.

Competenze

• PhD or MSc in Statistics.
• 10+ years of statistics experience in pharma or CROs.
• Strong knowledge of ICH/GCP and drug development process.
• Strong statistical methodology knowledge for drug development and trials.
• Ability to provide leadership to cross-functional teams at project level.
• Excellent communication of complex statistics to non-statisticians.
• Investigation of data and suitable analyses for decision making.
• Knowledge of CDISC data standards and SAS programming.

Mansioni

• Provide statistical input for Drug Development Programs.
• Lead statistical deliverables for eCTD submissions and regulatory documents.
• Support study design, sample size, randomization, analyses, and interpretation.
• Supervise statistical programmers and interact with CROs when outsourced.
• Review abstracts, posters, and manuscripts for publications.
• Participate in regulatory audits and Agency meetings to support submissions.
• Develop SAS programs for analyses and data listings.
• Collaborate to write regulatory documents and define SDT deliverables.
• Review Clinical Study Reports and adapt analyses as needed.
• Mentor junior statisticians and share knowledge in team settings.
• Contribute to SOPs and maintain compliance with GCP and CFR.

Conoscenze

Statistical leadership

Statistical analysis

Regulatory knowledge (ICH/GCP)

Clinical trial statistics

Data analysis

Communication skills

Cross-functional collaboration

Problem solving

Study design awareness

Team leadership

Formazione

PhD or MSc degree in Statistics

Strumenti

SAS

CDISC

R

Descrizione del lavoro

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Principal Statistician, Global Rare Diseases

Date: 29 Jul 2026

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 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 & 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 21.11 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 € 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.
• 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.