Principal Statistician
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 Agevolazioni 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 & DevelopmentOur 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 forThis is what you will doTo 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 studiesTo ensure statistical activities of the assigned projects are planned/executed according to regulatory requirements, internal standards, project timelines, under budget controlTo maximize the value of project data by data-mining, exploratory analysis to support drug development, hypothesis generation and publicationsYou will be responsible for 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 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 KPIsYou will need to haveA 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 requirementsStrong statistical methodology knowledge with application to drug developmentStrong experience in regulatory activity (submission preparation and interactions with authority in different geographical areasAbility to explore and analyse internal and external data, including Real World data, to investigate clinical questions and maximize the product valueExperience with products evaluation and due diligence Leadership and social influenceQuality orientationProblem solvingDecision makingCompensation RangeThe 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 m
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 Agevolazioni 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 & DevelopmentOur 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 forThis is what you will doTo 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 studiesTo ensure statistical activities of the assigned projects are planned/executed according to regulatory requirements, internal standards, project timelines, under budget controlTo maximize the value of project data by data-mining, exploratory analysis to support drug development, hypothesis generation and publicationsYou will be responsible for 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 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 KPIsYou will need to haveA 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 requirementsStrong statistical methodology knowledge with application to drug developmentStrong experience in regulatory activity (submission preparation and interactions with authority in different geographical areasAbility to explore and analyse internal and external data, including Real World data, to investigate clinical questions and maximize the product valueExperience with products evaluation and due diligence Leadership and social influenceQuality orientationProblem solvingDecision makingCompensation RangeThe 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 m