Clinical Statistician

Date:  12-Jan-2023
Department:  Global Clinical Development
Team:  R&D, Pharmacovigilance & Regulatory Affairs
Job Type:  Direct Employee
Contract Type:  Permanent
Location: 

Parma, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). 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: Discover more here

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, chemical manufacturing and controls, 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) and Toronto (Canada).

 

Who we are looking for

Main Responsibilities

•    As part of the Clinical Development Plan Team, to provide scientifically rigorous statistical expertise to clinical development plans, study design, statistical analysis, interpretation and communication of clinical results for the assigned program(s)
•    Statistical input to clinical studies (study design, statistical methodology), ensuring methods are applied consistently within a program and in line with regulatory guidelines.
•    To oversee the statistical deliverables of clinical studies included in the program, providing input to statistical documents prepared by external vendors or internal statisticians assigned to specific studies to guarantee high quality and consistency within the program(s) 
•    To provide training and support to junior statisticians working on individual studies.
•    To provide statistical input to products evaluation and due diligence
•    To represent statistics in interacting with Regulatory Agencies and Health Technology Assessment (HTA) bodies
•    To write/review regulatory documents (Briefing Books, eCTD modules) and to lead the preparation of all the statistical deliverables required by regulatory submission (ISS, ISE, data package) ensuring compliance with regulatory requirements 
•    To maximize the value of data by exploratory analysis
•    To write/review abstracts, posters, publications, and presentations to statistical conferences 
•    To contribute to internal initiatives aimed to drive innovation, implementation of innovative studies design and statistical methods
 

Experience Required

Previous experience of at least 2 years in a similar job, in pharmaceutical company and/or Contract Research Organizations. 

Education

Master degree or PhD in Statistics.

Languages

English, fluent

Technical Skills

•    Good experience in clinical development 
•    In depth knowledge of statistical methods that apply to clinical trials: from first in human and PK studies, to phase II dose-finding and pivotal studies. Knowledge on RWE studies 
•    Experience of regulatory interactions and submissions
•    Excellent knowledge of international standards (CDISC SDTM and ADaM)
•    Good knowledge of regulatory guidelines and requirements for data submission in different geographical areas (US, China, Japan)
•    Good SAS programming. Knowledge of R programming is a plus

Soft Skills

  • Communication skills
  • Attention to details
  • Goal orientation
  • Problem solving
  • Quality orientation

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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