Senior Clinical Statistics Lead (Hybrid)

Chiesi Group; Parma; Hybrid; EUR 59,000 - 74,000; Full time

Benefits offered by this job

Private medical insurance

Flexible benefits programme

Relocation support

Job summary

Chiesi Group is seeking a senior statistician to provide leadership in statistical methodology for clinical drug development. You will represent statistics in the Clinical Development Plan, support other statisticians, and ensure regulatory compliance across studies.

The role involves data mining, exploratory analyses, and contributing to regulatory submissions (ISS/ISE) while collaborating with external statistical experts.

Qualifications

• Significant experience with statistics applied to clinical trials within pharma/biotech environments.
• Lead or contribute to statistical aspects of drug development programs.
• Strong understanding of regulatory requirements and submission processes.

Responsibilities

• Provide statistical leadership to clinical drug development and external opportunity evaluation.
• Represent statistics within the CDP team and ensure consistency across studies.
• Ensure statistical activities comply with regulatory requirements, timelines, and budgets.
• Maximize data value through data mining, exploratory analyses, and publications.
• Lead preparation of statistical deliverables for regulatory submissions (ISS, ISE, data package).
• Provide input to product evaluation and due diligence; write/review abstracts, posters, and presentations.

Skills

Statistics in clinical trials

Education

PhD or MSc in Statistics

Job description

Chiesi Group is seeking a senior statistician to provide leadership in statistical methodology for clinical drug development. You will represent statistics in the Clinical Development Plan, support other statisticians, and ensure regulatory compliance across studies.

The role involves data mining, exploratory analyses, and contributing to regulatory submissions (ISS/ISE) while collaborating with external statistical experts.