Statistician Lead

About the Role

We are seeking a highly skilled Statistician Lead to join our R&D team at Chiesi Farmaceutici S.p.A. in Italy or Sweden. As a key member of our Clinical Development team, you will be responsible for providing statistical leadership to clinical drug development and external opportunity evaluation.

Main Responsibilities

• Provide scientifically rigorous statistical expertise to clinical development plans, study design, statistical analysis, interpretation, and communication of statistical results.
• Responsible for quality and timelines of all statistical deliverables of assigned projects/studies, including review and approval of key statistical vendor deliverables.
• Share project-related information with statistician(s) involved in the project and oversee their activities to ensure a consistent approach across studies.
• Provide statistical input to submission plans and represent statistics in interactions with regulatory agencies and Health Technology Assessment (HTA) bodies.
• Write and review regulatory documents, including Briefing Books and eCTD modules.
• Lead the preparation of all statistical deliverables required by regulatory submission, ensuring compliance with regulatory requirements.
• Maximize the value of data by data mining and post-hoc analysis.
• Contribute to the development of internal standards and process definition/improvement, SOPs writing/review.
• Represent statistics for auditing and regulatory inspection.

Requirements

• A significant experience in statistics applied to clinical trials acquired within pharmaceutical companies or CROs.
• PhD or MSc degree in Statistics.
• Advanced understanding of drug development process and regulatory requirements.
• Strong experience in regulatory activity, 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.

What We Offer

You will join a dynamic, fast-growing, and challenging environment at Chiesi Farmaceutici S.p.A. We believe that our people are our most valuable asset, and we invest in continuous training, learning, and development. We strive to promote and satisfy development needs, paying attention to the quality of our working environment and collective well-being. We offer flexible working approaches, remote working, support in the relocation process, tax assistance service for foreign colleagues, and many other people-care services.