Remote Biostatistician for Regulatory Clinical Trials

Hire Feed; Milano; Remoto; EUR 78.000 - 113.000; Tempo pieno

Descrizione del lavoro

Hire Feed is seeking a Biostatistician (Remote) to join a global life sciences team. The role focuses on analyzing clinical trial data, designing statistical methodologies, and ensuring compliance with regulatory standards, with reports prepared for health authority submissions.

The candidate will work across SAS, R, or Python to support regulatory filings, collaborate with clinicians and data managers, and contribute to study reports with tables and listings for submission.

Competenze

• Proficiency in SAS, R, or Python for data analysis and visualization.
• Experience designing statistical methodologies for clinical trials and regulatory submissions.
• Strong biostatistical knowledge including survival analysis, regression, and longitudinal data analysis.
• Ability to interpret and communicate complex statistical findings to non-statistical stakeholders.
• Knowledge of FDA/EMA/regulatory guidelines for clinical trial data analysis.

Mansioni

• Design and implement statistical plans for clinical trials, including sample size calculations and power analyses.
• Perform statistical analysis of clinical trial data using SAS, R, or Python to support regulatory submissions.
• Develop statistical models to evaluate safety and efficacy endpoints in clinical trials.
• Collaborate with cross-functional teams including clinicians, data managers, and regulatory affairs to ensure alignment with study objectives.
• Prepare statistical sections of clinical study reports, including tables, figures, and listings.

Conoscenze

Biostatistics

Survival analysis

Longitudinal data analysis

Communication of results

Regulatory understanding

Strumenti

SAS

R

Python

Descrizione del lavoro

Hire Feed is seeking a Biostatistician (Remote) to join a global life sciences team. The role focuses on analyzing clinical trial data, designing statistical methodologies, and ensuring compliance with regulatory standards, with reports prepared for health authority submissions.

The candidate will work across SAS, R, or Python to support regulatory filings, collaborate with clinicians and data managers, and contribute to study reports with tables and listings for submission.