Data Analyst I
1 N Waukegan Road North Chicago, IL 60064 US
Under limited supervision, the Data Analyst (will use the term “Analyst” going forward in this document) is responsible for designing, creating and verifying data reports, metrics and visualizations of post market surveillance and sales data. The work product supports management reviews and regulatory submissions, as well as other diverse areas of the business. The Analyst is responsible for project management of the reports, including defining and negotiating reporting requirements with various clients. The Analyst works in a highly collaborative manner, often educating clients on ways to address their data oriented problems. They document workflow, status, appropriate verification and approvals of reports. They also ensuring work product meets the requirements of clients, incorporating learning into future continuous improvement. The Analyst supports creation of aggregate safety reports, signal detection reports and presentations for various management reviews, including investigating safety signals, including use of statistical technique and data science. The Analyst uses a wide variety of tools, especially Business Objects family of applications, advanced spreadsheet work and statistical packages. Support key business initiatives as required, providing statistical analysis, application design and interactive visualizations of data
• Creates complex data reports (ad hoc and validated standard reports) for various internal and external clients. Internal clients include Medical Safety, Post Market Quality, Product Surveillance, R&D and CAPA teams. External clients include health ministries (MOH), FDA and other regulatory bodies. Work supports areas such as regulatory submissions, Signal Detection, CAPA, Risk Management and other clients.
• Performs verification (QC) and documents the verification of reports and responses to regulatory authorities related to post-market data. Provides tracking and status.
• Ensures appropriate sign-off, report verification, distribution, and archival of completed reports and correspondence.
• Collaborates with clients to outline strategies to address regulatory questions or formal “Requests for Information” by researching and preparing reports on safety data for regulatory agencies, etc. Serves as team member (along with Medical Safety, Post Market Surveillance, Regulatory, etc.) in defining and executing requests and mandatory reporting, including both ad-hoc requests and establishing new re-occurring reports.
• Provides project management support for ad-hoc query management activities.
• Facilitates report request across a variety of functional groups to meet the clients requirements, including collaborating across different functional departments to attain the necessary information.
• Design and runs database queries and collects supporting documentation for report preparation.
• Performs statistical studies & analysis to support clients.
• Supports signal management activities, including risk assessment and analysis of root cause, including signal investigation and analysis.
• Provides assistance to design teams implementing post-approval Risk Management Plans (e.g. providing data/ad-hoc reports for regulatory submissions, analyzing special safety topics, etc.)
• Drafts SOPs, DOPs, presentations and work instructions for departmental practice.
• 1+ years’ business experience in business analytics, manufacturing data analytics, data mining, or statistical modeling in a cGMP related industry. Manufacturing life science experience is preferred.
• Knowledge of global regulatory requirements for pharmaceutical, medical devices, and combination products. Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
• Ability to execute analytical investigations methodically while outputting reproducible insights and analyses.
• Software experience – Demonstrated proficiency with a business intelligence package such as BI tools such as Business Objects suite.
• Familiarity with at least one statistical programming package (e.g., R, SAS, JMP, Minitab) preferred.
• Familiarity in SQL and relational databases (such as Oracle) is also preferred
• Strong problem solving and interpersonal skills and ability to work as part of a diverse team including data engineers, IT, and business analytics teams.
• Strong communication skills, written and verbal, and strong attention to detail.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.