Remote Lead Statistician, Rare Diseases

Chiesi Farmaceutici S.p.A.; Parma; In loco; EUR 59.000 - 90.000; Tempo pieno

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. is seeking a Principal Statistician for Global Rare Diseases located in Parma, IT.

The role focuses on providing statistical expertise for Drug Development Programs, supporting regulatory submissions, and leading statistics throughout clinical trials, including interactions with CROs. The position requires a PhD or MSc in Statistics with 10+ years in pharma statistics, strong ICH/GCP knowledge, and SAS/CDISC proficiency.

Competenze

• PhD or MSc in Statistics.
• 10+ years of statistics experience in pharma or CROs.
• Strong knowledge of ICH/GCP and drug development process.
• Strong statistical methodology knowledge for drug development and trials.
• Ability to provide leadership to cross-functional teams at project level.
• Excellent communication of complex statistics to non-statisticians.
• Investigation of data and suitable analyses for decision making.
• Knowledge of CDISC data standards and SAS programming.

Mansioni

• Provide statistical input for Drug Development Programs.
• Lead statistical deliverables for eCTD submissions and regulatory documents.
• Support study design, sample size, randomization, analyses, and interpretation.
• Supervise statistical programmers and interact with CROs when outsourced.
• Review abstracts, posters, and manuscripts for publications.
• Participate in regulatory audits and Agency meetings to support submissions.
• Develop SAS programs for analyses and data listings.
• Collaborate to write regulatory documents and define SDT deliverables.
• Review Clinical Study Reports and adapt analyses as needed.
• Mentor junior statisticians and share knowledge in team settings.
• Contribute to SOPs and maintain compliance with GCP and CFR.

Conoscenze

Statistical leadership

Statistical analysis

Regulatory knowledge (ICH/GCP)

Clinical trial statistics

Data analysis

Communication skills

Cross-functional collaboration

Problem solving

Study design awareness

Team leadership

Formazione

PhD or MSc degree in Statistics

Strumenti

SAS

CDISC

R

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. is seeking a Principal Statistician for Global Rare Diseases located in Parma, IT.

The role focuses on providing statistical expertise for Drug Development Programs, supporting regulatory submissions, and leading statistics throughout clinical trials, including interactions with CROs. The position requires a PhD or MSc in Statistics with 10+ years in pharma statistics, strong ICH/GCP knowledge, and SAS/CDISC proficiency.