Senior Statistician

OPIS s.r.l.; Italia; Remoto; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading international CRO is seeking a Senior Statistician for a remote position. The role involves managing statistical activities for clinical studies, liaising with stakeholders, and mentoring junior staff. Ideal candidates will possess a degree in Statistics along with a minimum of 3 years experience in clinical research and proven expertise in SAS and other statistical methodologies. Competitive salary and benefits offered in a rapidly expanding company.

Servizi

Competitive salary

Bonuses

Benefits

Opportunities for professional growth

Competenze

• Minimum 3 years of experience in CROs, biotech, pharma, or research institutions.
• Proven expertise in statistics applied to clinical research.
• Fluent in English.

Mansioni

• Manage all statistical activities for assigned clinical studies, including study design and reporting.
• Review study objectives with the study team and prepare detailed statistical analysis plans.
• Mentor junior staff and provide training for project teams.

Conoscenze

Statistics applied to clinical research

Communication

Teamwork

Proactive and organized

Knowledge of drug development processes

Formazione

Degree in Statistics or related field

Strumenti

SAS

Statistical software

Descrizione del lavoro

Due to our ongoing global expansion, we have a great opportunity for a Senior Statistician to join our growing team, on a fully remote basis.

About the Role

The Senior Statistician reports to the Biostatistics Coordinator, serves as the primary point of contact for statistical matters with the study team, liaises with external stakeholders, and ensures clinical data are analyzed in compliance with applicable standards, regulatory guidelines, and OPIS SOPs.

The Senior Statistician provides advice on statistical methodology and study design, and mentors junior staff.

Position Details

This is a remote (work from home) position.

Responsibilities

1. Manage all statistical activities for assigned clinical studies, including study design, sample size estimation, analysis plan, analysis populations, statistical analyses, and reporting.
2. Work independently with minimal support from the Head of Biostatistics Unit.
3. Contribute to clinical study design by providing appropriate statistical methodology.
4. Review study objectives and endpoints with the study team or Sponsor, and prepare detailed statistical analysis plans (SAP).
5. Generate randomization lists or procedures, collaborating with the Data Manager on documentation.
6. Collaborate with Data Management to review and design CRFs, define protocol deviations, and data quality controls.
7. Develop SAS programs or collaborate with SAS programmers to generate analysis datasets, mock shells, TFLs, and reports.
8. Perform quality control on deliverables from other statisticians or programmers.
9. Write statistical reports and sections of clinical study reports.
10. Track activities and milestones to ensure timely delivery.
11. Liaise with Sponsor and external stakeholders regarding statistical activities and results.
12. Present findings at team meetings and share knowledge.
13. Help establish and maintain SOPs related to biostatistics.
14. Organize and perform training for project teams and mentor junior staff.

Qualifications

• Degree in Statistics or related field, with specialization in medical or epidemiological statistics.
• Minimum 3 years of experience in CROs, biotech, pharma, or research institutions.
• Proven expertise in statistics applied to clinical research.
• Solid knowledge of drug development processes and GCP guidelines.
• Proficiency in SAS and other statistical software.
• Experience with CDISC standards (SDTM, ADaM).
• Knowledge of clinical trial systems (EDC, IVRS, IWRDS, EPRO, CTMS, etc.).
• Excellent communication and teamwork skills.
• Strong commitment to quality, proactive, organized, flexible, and innovative.
• Fluent in English.

What We Offer

Competitive salary, bonuses, and benefits, with opportunities for professional growth within an expanding international company.

About OPIS

OPIS is an international CRO with 25 years of experience in Phase I-IV studies, medical devices, and non-interventional research. We leverage state-of-the-art technology and innovative approaches across all phases of drug development and medical device trials, with global locations providing comprehensive clinical research services.

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