Principal Statistician, Rare Diseases — Remote Europe

Chiesi Group; España; A distancia; EUR 59.000 - 74.000; Jornada completa

Descripción de la vacante

Chiesi Group in Europe (remote) seeks a Senior Statistician to provide statistical leadership for drug development programs, regulatory submissions, and data analyses across trials. You will guide study design, analysis plans, and collaboration with cross-functional teams to ensure high-quality deliverables.

Candidates must have a PhD/MSc in Statistics, 10+ years in pharma statistics, strong knowledge of ICH/GCP and CDISC, and proficiency in SAS.

Formación

• PhD or MSc in Statistics.
• >10 years of statistics experience in clinical trials.
• Strong knowledge of drug development and regulatory requirements (ICH/GCP).
• Strong statistical methodology with application to drug development and trials.
• Ability to lead cross-functional teams on projects.
• Excellent communication to non-statistical audiences.
• Knowledge of CDISC standards.

Responsabilidades

• Provide statistical leadership for Drug Development Programs and regulatory submissions.
• Lead statistical activities for Data Review Meetings and CRO interactions.
• Review Clinical Study Reports and regulatory documents; support eCTD submissions.
• Collaborate with cross-functional teams to define statistical analysis plans and derived data sets.

Conocimientos

SAS

Clinical trials

Regulatory knowledge

Statistical leadership

Communication skills

Data analysis

CDISC

ICH/GCP

Educación

PhD or MSc in Statistics

Herramientas

SAS System

R

Descripción del empleo

Chiesi Group in Europe (remote) seeks a Senior Statistician to provide statistical leadership for drug development programs, regulatory submissions, and data analyses across trials. You will guide study design, analysis plans, and collaboration with cross-functional teams to ensure high-quality deliverables.

Candidates must have a PhD/MSc in Statistics, 10+ years in pharma statistics, strong knowledge of ICH/GCP and CDISC, and proficiency in SAS.