Principal Statistician (Clinical Trials)

Location: Preferably based at the headquarters in Parma, Italy, with a flexible hybrid working arrangement; candidates based elsewhere in Europe will also be considered.

Salary: €59,000–€74,000 annually, plus annual bonus and benefits.

Company

Chiesi is an international research-focused biopharmaceutical group operating in more than 30 countries, with research and development activities across clinical development, regulatory affairs, pharmacovigilance, drug delivery, and related areas.

What you will do

• Provide statistical leadership for clinical drug development, clinical development plans, study design, analysis, interpretation, and communication of results.
• Represent statistics within Clinical Development Plan teams and support or oversee other statisticians to ensure consistent approaches across studies.
• Plan and execute statistical activities according to regulatory requirements, internal standards, timelines, and budget controls.
• Lead statistical deliverables for regulatory submissions, including ISS, ISE, data packages, briefing books, and eCTD modules.
• Provide statistical input to product evaluation, due diligence, submission planning, regulatory agency and HTA interactions, audits, and inspections.
• Use data mining, exploratory and post-hoc analyses to support drug development, hypothesis generation, publications, and product value assessment.

Requirements

• Significant experience applying statistics to clinical trials within pharmaceutical companies or CROs.
• PhD or MSc degree in Statistics.
• Fluent English.
• Advanced understanding of the drug development process and regulatory requirements.
• Strong knowledge of statistical methodology applied to drug development.
• Strong regulatory experience, including submission preparation and interactions with authorities in different geographical areas.
• Ability to explore and analyze internal and external data, including Real World data, to investigate clinical questions and maximize product value.
• Experience with product evaluation and due diligence.
• Leadership and social influence, quality orientation, problem solving, and decision-making skills.

Culture & Benefits

• Flexible hybrid and remote working options, with the role primarily based in Parma or elsewhere in Europe.
• Annual bonus subject to company and individual performance.
• Pension, private medical insurance, wellbeing and flexible benefits programmes.
• Healthcare programmes, work-life balance initiatives, relocation support, training resources, and tax assistance for foreign colleagues.
• Culture focused on reliability, transparency, ethical behaviour, sustainability, diversity, and inclusion.