Regulatory & Medical Affairs - Data Analyst

Clinical Safety Analytics Associate


Summary: Clinical Safety Analytics Associate will play a critical role within the PV CoE. This position focuses on assisting with analyzing data and deriving insights from clinical and safety data sources to generate evidence and support decision making across the organization. The Associate will leverage a variety of analytics and visualization techniques to contribute to research, clinical development, drug safety and post-marketing activities.


Roles & Responsibilities
Collaborates and works closely with cross-functional teams, including data analysts/engineers and business stakeholders, to understand their needs and gather requirements
Cleans, transforms and pre-processes data to ensure data quality, consistency and compatibility for analysis
Develops and implements data analysis plans to answer clinical and safety questions
Applies analytical and/or statistical techniques to analyze data and generate insights on safety questions
Visualizes data and results to share insights with technical and non-technical cross-functional stakeholders
Interprets and communicates findings through reports, presentations and visualizations
Stays up to date and compliant with the regulatory landscape related to drug safety and data analyses
Works closely with PV CoE and other stakeholders, sharing knowledge and best practices within the broader safety and analytics teams


Skills & Competencies
Strong understanding of data sources, such as clinical trial data, electronic health records, and other healthcare databases
Proficiency in data pre-processing, cleaning and transformation techniques to ensure data quality and compatibility for analysis
Knowledge of relevant analytical and statistical methodologies, such as regression analysis, survival analysis etc.
Excellent problem-solving skills and the ability to derive meaningful insights from complex real-world data sets
Excellent communication and presentation skills to effectively convey complex concepts and findings
Ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously
Strong attention to detail and accuracy in data analysis and interpretation


Experience
Bachelor's or Master's (preferred) degree in a relevant field, such as Biostatistics, Analytics, Engineering or related discipline.
Minimum of 3-5 years of experience in data analysis, statistical modeling, and data visualization, preferably within the biopharma or healthcare industry.
Experience applying statistical and analytical techniques, to analyze real world data
Experience with Python or R or SAS and SQL required
Working knowledge of visualization tools, such as Tableau or Power BI is preferred
Experience or familiarity with the biopharma industry