Senior Statistician

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: Parma, Italy

This is what you will do

Provide statistical expertise on clinical trials from design to execution and reporting; to ensure statistical methodology and regulatory requirements are properly applied on clinical trials, high quality and timely delivery of study related statistical deliverables

You will be responsible for

• To provide statistical expertise to clinical studies, from study design, sample size calculations, endpoints definition and statistical methods, to evaluation and interpretation of study results
• To interact with Principal Statistician(s) and Clinical Development Plan (CDP) team to ensure alignment of study characteristics with the project development plan
• To review/develop the Study Protocol, Review CRF and External Data structure, Randomization Specifications, collaborate to study systems setup
• To prepare/review randomization lists using internal system and test Interactive Response System (IRT)
• To write / review Statistical Analysis Plan, including the definition of statistical methods and statistical tables, figures, and data listings for clinical summary reports
• To manage and guide providers, setting requirements, preparing the Request for Proposals and monitoring performance
• To collaborate with study team in the definition and monitoring of clinical study risks and ongoing evaluation of quality of data and trends
• To review analysis datasets structure and related metadata to ensure CDISC standards are properly implemented
• To plan and coordinate Data Review activities before database lock
• To prepare with study team the executive summary and results presentation in line with expected timelines
• To maximize the value of data by data mining, post-hoc analysis; to write/review abstracts, posters, presentations for publication
• To review the Clinical Study Report
• To represent statistics for auditing / regulatory inspection

You will need to have

• PhD or MSc degree in Statistics
• A significant experience in statistics applied to clinical trials acquired within pharmaceutical companies or CROs
• Good knowledge of drug development process and regulatory requirements
• Statistical methodology knowledge with application to drug development and clinical trials
• Good knowledge of international standards for data collection (CDISC)
• Ability to explore and analyse data to investigate clinical questions ied to clinical trials acquired within pharmaceutical companies or CROs
• Proficiency in SAS System, R, other statistical software
• Knowledge of tools for sample size calculation

Location

Parma, with remote working available

What we offer

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.