Regulatory Data & Analytics Business Analyst

Insight Global; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Insight Global is seeking a Business Analyst to collaborate with Quality, Regulatory and clinical product owners to understand data and analytics requirements in the Pharmaceutical/Biotech sector. You will craft functional and technical requirements, map stages to targets, and own data source documentation.

You will translate requirements into epics and user stories for engineering, coordinate testing cycles, and support data governance through metadata management and data catalogs.

Qualifications

• Experience with Business and data analysis in Pharmaceutical/Biotech Industry in GxP domain.
• Knowledge of 21CFR Part 11 and other GxP governing procedures.
• Collaborate with business product owners and users to understand data and analytics requirements.
• Translate business requirements into implementation-ready Epics and user stories; agile methodologies.
• Familiarity with Data Governance processes and tools such as Collibra.
• Ability to analyze data in the domain to create concise descriptive metadata.
• Proficient in Python and other data analysis tools.

Responsibilities

• Collaborate with Quality, Regulatory and clinical business product owners and end users to understand data and analytics requirements.
• Craft functional and technical requirements, stage-to-target mapping documents.
• Analyze and triage business requirements to understand scope and data sources.
• Own creation of functional requirement documents detailing metrics, KPIs, and data sources.
• Create data mapping documents and break down epics and user stories for engineering teams.
• Coordinate with project manager and reporting lead to manage scope and user feedback.
• Collaborate with dev and engineering teams on delivery of data products.
• Coordinate testing and validation teams and manage testing cycles including UAT; verify test scripts against requirements.
• Assist in implementing data governance standards through cataloguing and metadata management.

Skills

Business data analysis

GxP domain experience

Data governance

Agile / Epics & user stories

Python

Metadata management

Tools

Collibra

Job description

Insight Global is seeking a Business Analyst to collaborate with Quality, Regulatory and clinical product owners to understand data and analytics requirements in the Pharmaceutical/Biotech sector. You will craft functional and technical requirements, map stages to targets, and own data source documentation.

You will translate requirements into epics and user stories for engineering, coordinate testing cycles, and support data governance through metadata management and data catalogs.