Biostatistician (Remote)

Hire Feed; Deutschland; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Hire Feed is seeking a Biostatistician on a full-time basis to join a global pharmaceutical manufacturing leader. The role focuses on analyzing clinical trial data and ensuring regulatory compliance while developing robust statistical methods.

You will design statistical plans, perform analyses with SAS, R, or Python, and contribute to study reports submitted to health authorities, influencing regulatory decisions and patient outcomes.

Qualifikationen

• Proficiency in SAS, R, or Python for data analysis.
• Experience designing statistical methodologies for trials and regulatory submissions.
• Strong biostatistical knowledge: survival analysis, regression, longitudinal data.
• Ability to communicate complex results to non-statisticians.
• Familiarity with FDA/EMA guidelines for trial data analysis.

Aufgaben

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

Kenntnisse

SAS

R

Python

Survival analysis

Regression modeling

Longitudinal data analysis

Data interpretation

Regulatory guidelines knowledge

Jobbeschreibung

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 influence on regulatory approvals.

Equal Opportunity Employer:

We hire based on skills and expertise. All qualified candidates are welcome regardless of background, experience, or prior employment history. Applications are reviewed solely on demonstrated technical ability and qualifications.