Statistician

p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: /p pParma, IT /p bAbout us /b pChiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. p pAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /We believe our differences make us stronger. p bChiesi Research Development /b pOur RD 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, RD 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). /p h3This is what you will do /h3 pTo provide statistical leadership to clinical drug development and external opportunity evaluation to ensure appropriate statistical methodology is applied to the assigned project(s) /p pTo represent statistics within the Clinical Development Plan (CDP) team, to support other statistician(s) involved in the project, ensuring consistent approach across studies /p pTo ensure statistical activities of the assigned projects are planned/executed according to regulatory requirements, internal standards, project timelines, under budget control /p pTo maximize the value of project data by data-mining, exploratory analysis to support drug development, hypothesis generation and publications /p h3You will be responsible for /h3 pTo provide scientifically rigorous statistical expertise to clinical development plans, study design statistical analysis, interpretation and communication of statistical results /p ul liResponsible for quality and timelines of all statistical deliverables of the assigned projects / studies including review / approve key statistical vendor deliverables /li liTo share project related information to statistician(s) involved in the project and oversee their activities to ensure consistent approach across studies /li liTo provide statistical input to submission plan, to represent statistics in interacting with regulatory agencies and Health Technology Assessment (HTA) bodies /li liTo write/review regulatory documents (Briefing Books, eCTD modules) /li liTo lead the preparation of all the statistical deliverables required by regulatory submission (ISS, ISE, data package) ensuring compliance with regulatory requirements /li liTo provide statistical input to product evaluation and due diligence /li liTo maximize the value of data by data mining, post-hoc analysis; to write/review abstracts, posters, presentations for publication /li liTo write/review abstracts, posters, presentations for publication /li liTo contribute to development of internal standards and to process definition / improvement, SOPs writing / review /li liTo contribute to internal initiatives, lessons learned and trainings /li liTo represent statistics for auditing / regulatory inspection /li liTo create and maintain collaborative relationship with external Statistical experts and groups KPIs /li /ul h3You will need to have /h3 ul liA significant experience in statistics applied to clinical trials acquired within pharmaceutical companies or CROs /li liPhD or MSc degree in Statistics /li liAdvanced understanding of drug development process and regulatory requirements /li liStrong statistical methodology knowledge with application to drug development /li liStrong experience in regulatory activity (submission preparation and interactions with authority in different geographical areas /li liAbility to explore and analyse internal and external data, including Real World data, to investigate clinical questions and maximize the product value /li liExperience with products evaluation and due diligence /li liLeadership and social influence /li liQuality orientation /li liProblem solving /li liDecision making /li /ul h3Compensation Range /h3 pThe 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. /This range reflects the typical compensation expected for candidates wi