Principal Statistician, Global Rare Diseases

TL;DR

Principal Statistician, Global Rare Diseases (Biostatistics/SAS): Provide statistical expertise for drug development programs, including study design, sample size calculation, randomization, and statistical analysis for interventional, observational, and registry clinical trials with an accent on regulatory submission quality and appropriateness of statistical deliverables. Focus on building and reviewing Statistical Analysis Plans, leading data review activities, and supporting regulatory agency queries and audits while ensuring compliance with GCP and related standards.

Location: Europe - Remote

Salary: €59,000 minimum (Italy-based; localized package for other countries)

Company

Chiesi is an international research-focused biopharmaceutical group developing and marketing innovative drugs across multiple therapeutic areas.

What you will do

• Provide statistical input and leadership for drug development programs and cross-functional data summarization.
• Support study design, sample size calculation, patient randomization, statistical methods, analyses, and interpretation of clinical trial results.
• Perform or supervise statistical activities for clinical trials, coordinating with CROs and external vendors when outsourced.
• Review and develop Statistical Analysis Plans, including derived data set definitions and statistical tables/figures/listings for clinical summary reports.
• Lead statistical activities for data review meetings and support regulatory document writing and eCTD statistical deliverables.
• Review publications materials and address statistical queries from regulatory agencies; participate in audits/inspections as required.

Requirements

• PhD or MSc in Statistics.
• 10+ years of experience applying statistics to clinical trials in pharmaceutical companies or CROs.
• Strong knowledge of drug development process and regulatory requirements (e.g., ICH/GCP).
• Strong statistical methodology experience for drug development and clinical trials, including ability to investigate data and propose appropriate analyses.
• Proficiency in SAS System and knowledge of sample size calculation tools.
• Fluent English.

Nice to have

• Experience with clinical trials for rare diseases, including small-population study design and analysis approaches.
• Experience with adaptive design and/or Bayesian approaches.
• Experience interacting with regulatory agencies, researchers, and healthcare stakeholders.
• Knowledge of R or other statistical programming languages.

Culture & Benefits

• Annual bonus scheme based on company and individual performance.
• Comprehensive benefits package including pension and private medical insurance, wellbeing and flexible benefits.
• Flexible working arrangements with remote work options.
• Relocation support and tax assistance services for foreign colleagues.
• Training and development resources to support professional growth.

Hiring process

• Recruitment process includes evaluation of skills, experience, qualifications, and internal equity considerations for the final offer.
• Role may involve participation in the company recruitment program as needed.