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Clinical Safety Insights Analyst
2 months ago
Company: System One Holdings, LLC
Location: Hybrid
Type: Contract
Overview
System One Holdings, LLC is seeking a Clinical Safety Analytics Associate to join our team. This role is pivotal within the Pharmacovigilance Center of Excellence (PV CoE). The successful candidate will focus on analyzing clinical and safety data to derive actionable insights that support decision-making across various functions within the organization. Utilizing a range of analytical and visualization methodologies, the Associate will contribute significantly to research initiatives, clinical development processes, drug safety evaluations, and post-marketing surveillance activities.
Key Responsibilities
• Collaborate effectively with cross-functional teams, including data analysts, engineers, and business stakeholders, to gather requirements and understand their analytical needs.
• Design and execute comprehensive data analysis plans aimed at addressing clinical and safety inquiries.
• Employ statistical and analytical methodologies to interpret data and generate insights related to safety concerns.
• Create visual representations of data and findings to communicate insights to both technical and non-technical stakeholders.
• Present and interpret results through detailed reports, presentations, and visual aids.
• Maintain current knowledge of regulatory requirements pertaining to drug safety and data analysis practices.
Qualifications
- Bachelor's or Master's degree in a relevant discipline such as Biostatistics, Analytics, Engineering, or a related field.
- A minimum of 4 years of experience in data analysis.
- Proficiency in applying statistical and analytical techniques to real-world data.
- Experience with programming languages such as Python, R, or SAS, as well as SQL.
- Familiarity with data visualization tools, including Tableau or Power BI.
- Understanding of the biopharmaceutical industry is preferred.