06 ott - Roma
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Role : Biostatistician (Remote)
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Location : Remote (Work from Anywhere)
Role Overview:
We are hiring for one of our clients, seeking a Biostatistician to work on a full-time basis. The role involves analyzing clinical trial data and ensuring compliance with regulatory standards. Primary tasks include designing statistical methodologies, conducting data analysis, and preparing reports for submission to health authorities.
Key Responsibilities:
• 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.
Required Skills & Qualifications:
• Proficiency in statistical software such as SAS, R, or Python for data analysis and visualization.
• Experience in designing statistical methodologies for clinical trials and regulatory submissions.
• Strong understanding of biostatistical principles, including survival analysis, regression modeling, and longitudinal data analysis.
• Ability to interpret and communicate complex statistical findings to non-statistical stakeholders.
• Knowledge of FDA, EMA, or other regulatory guidelines for clinical trial data analysis.
More About the Opportunity:
This role offers a unique opportunity to work with a global leader in the pharmaceutical manufacturing industry, contributing to the development of life-saving therapies. The position involves high-impact projects with direct in
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