Central Statistical Analyst

2 days ago


Bengaluru, Karnataka, India Volibits Full time
Job Overview

We are seeking a highly skilled Central Statistical Analyst to join our team at Volibits.

Estimated Salary: ₹1,500,000 - ₹2,500,000 per annum.

Job Description

This role involves centralized monitoring and checks to ensure data integrity and mitigate risks across clinical trial sites. The ideal candidate will have experience in centralized monitoring techniques to detect data anomalies, identify site misconduct, and optimize site performance.

  • Data Evaluation and Analysis:
    • Perform real-time monitoring of site data from a central location to assess risks and identify anomalies.
    • Utilize advanced statistical monitoring algorithms to detect outliers and inconsistencies across clinical trial data.
    • Analyze data from various sources, including baseline, clinical, laboratory, treatment, and patient-reported outcomes.
  • Risk-Based Monitoring (RBM):
    • Collaborate with cross-functional teams to implement RBM strategies, targeting site visits based on identified risks.
    • Inform Clinical Research Associates (CRAs) about site-specific risks and guide escalation and intervention strategies.
  • Process Improvement:
    • Develop and refine processes to enhance the detection of erroneous data and site misconduct.
    • Evaluate and improve the effectiveness of Key Risk Indicators (KRIs) through comprehensive data analysis.
Qualifications

To be successful in this role, you will need:

  • Bachelor's degree or higher in Biostatistics, Data Science, Clinical Research, or a related field.
  • Proven experience in statistical monitoring, centralized monitoring, or clinical trial risk management.
  • Strong understanding of Risk-Based Monitoring (RBM) principles and practices.
  • Proficiency in statistical software (e.g., SAS, R, Python) and data visualization tools.
  • Familiarity with regulatory standards and guidelines in clinical research (e.g., ICH-GCP, FDA, EMA).
About Us

Volibits is a leading company in the industry, committed to excellence and innovation. We offer a dynamic work environment and opportunities for growth and development.



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