Principal Statistician

Chiesi Group; Parma; Hybrid; EUR 59,000 - 74,000; Full time

Benefits offered by this job

Private medical insurance

Flexible benefits programme

Relocation support

Job summary

Chiesi Group is seeking a senior statistician to provide leadership in statistical methodology for clinical drug development. You will represent statistics in the Clinical Development Plan, support other statisticians, and ensure regulatory compliance across studies.

The role involves data mining, exploratory analyses, and contributing to regulatory submissions (ISS/ISE) while collaborating with external statistical experts.

Qualifications

• Significant experience with statistics applied to clinical trials within pharma/biotech environments.
• Lead or contribute to statistical aspects of drug development programs.
• Strong understanding of regulatory requirements and submission processes.

Responsibilities

• Provide statistical leadership to clinical drug development and external opportunity evaluation.
• Represent statistics within the CDP team and ensure consistency across studies.
• Ensure statistical activities comply with regulatory requirements, timelines, and budgets.
• Maximize data value through data mining, exploratory analyses, and publications.
• Lead preparation of statistical deliverables for regulatory submissions (ISS, ISE, data package).
• Provide input to product evaluation and due diligence; write/review abstracts, posters, and presentations.

Skills

Statistics in clinical trials

Education

PhD or MSc in Statistics

Job description

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

To provide statistical leadership to clinical drug development and external opportunity evaluation to ensure appropriate statistical methodology is applied to the assigned project(s)

To represent statistics within the Clinical Development Plan (CDP) team, to support other statistician(s) involved in the project, ensuring consistent approach across studies

To ensure statistical activities of the assigned projects are planned/executed according to regulatory requirements, internal standards, project timelines, under budget control

To maximize the value of project data by data-mining, exploratory analysis to support drug development, hypothesis generation and publications

You will be responsible for

• Responsible for quality and timelines of all statistical deliverables of the assigned projects / studies including review / approve key statistical vendor deliverables
• To share project related information to statistician(s) involved in the project and oversee their activities to ensure consistent approach across studies
• To provide statistical input to submission plan, to represent statistics in interacting with regulatory agencies and Health Technology Assessment (HTA) bodies
• To write/review regulatory documents (Briefing Books, eCTD modules)
• To lead the preparation of all the statistical deliverables required by regulatory submission (ISS, ISE, data package) ensuring compliance with regulatory requirements
• To provide statistical input to product evaluation and due diligence
• To maximize the value of data by data mining, post-hoc analysis; to write/review abstracts, posters, presentations for publication
• To write/review abstracts, posters, presentations for publication
• To contribute to development of internal standards and to process definition / improvement, SOPs writing / review
• To contribute to internal initiatives, lessons learned and trainings
• To represent statistics for auditing / regulatory inspection
• To create and maintain collaborative relationship with external Statistical experts and groups KPIs

You will need to have

• A significant experience in statistics applied to clinical trials acquired within pharmaceutical companies or CROs
• PhD or MSc degree in Statistics
• English fluent
• Advanced understanding of drug development process and regulatory requirements
• Strong statistical methodology knowledge with application to drug development
• Strong experience in regulatory activity (submission preparation and interactions with authority in different geographical areas
• Ability to explore and analyse internal and external data, including Real World data, to investigate clinical questions and maximize the product value
• Experience with products evaluation and due diligence
• Leadership and social influence
• Quality orientation
• Problem solving
• Decision making

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 budgeted salary range approved for this role is between € 59.000 and € 74.000. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position.

Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, 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.

Location

The position is preferably based at our headquarters in Parma, Italy, and offers a flexible hybrid working arrangement.

However, candidates based elsewhere in Europe will also be considered.

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.

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.