Date: 16 Oct 2024 Department: Global Clinical Development
Team: R&D, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type: Permanent
Location: Italy or Sweden, SE
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 employees. To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas.
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification , a recognition of high social and environmental standards . We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors . Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
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
Purpose
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
Main Responsibilities
To 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 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 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 Experience Required
A significant experience in statistics applied to clinical trials acquired within pharmaceutical companies or CROs
Education
PhD or MSc degree in Statistics
Languages
English fluent
Technical Skills
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 Soft Skills
Leadership and social influence Quality orientation Problem solving Decision making What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day , and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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