Senior Principal Post-Market Data Analytics Lead

Advita Ortho

Gainesville (FL)

On-site

USD 120,000 - 160,000

Full time

11 days ago
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Job summary

Advita Ortho in Gainesville, FL is seeking a Senior Principal Post-Market Complaint Data Analyst to lead analytics for post-market surveillance and regulatory reporting. This role drives data governance, advanced trending, signal detection, and provides executive-level insights to cross-functional teams, protecting patients and ensuring regulatory compliance.

The ideal candidate has 10+ years in data analytics within medical devices or biotech and expert skills in SQL, Python, R, SAS, and Power

Qualifications

  • Bachelor's degree in Biomedical Engineering, Life Sciences, Data Science, Statistics, Engineering, or related field; advanced degree preferred.
  • Minimum of 10 years of progressive data analytics experience in quality, post-market surveillance, or related field in medical devices, pharma, or biotech.
  • Minimum of 5 years leading post-market complaint trending, regulatory data reporting, or related analytics.
  • Experience influencing enterprise decisions and leading cross-functional initiatives without direct authority.

Responsibilities

  • Serve as enterprise SME for post-market complaint analytics, governance, and reporting.
  • Design advanced complaint trending, signal-detection, and risk-monitoring methods.
  • Establish data definitions, controls, dashboards, and reporting practices.
  • Synthesize data into executive-level insights for leadership and governance forums.
  • Lead cross-functional analytics initiatives with QA, Regulatory, Medical/Clinical, and Product teams.
  • Provide analytical support for regulatory submissions, health authority inquiries, and inspections.
  • Direct root cause and CAPA analyses; ensure defensible data-backed conclusions.
  • Improve data quality, system controls, and end-to-end complaint analytics processes; pursue automation.

Skills

Statistical analysis
Data visualization
SQL
Python
R
SAS
Power BI
Excel

Education

Bachelor's degree in a relevant field
Advanced degree preferred

Tools

Excel
Power BI
SQL
SAS
R
Python

Job description

Advita Ortho in Gainesville, FL is seeking a Senior Principal Post-Market Complaint Data Analyst to lead analytics for post-market surveillance and regulatory reporting. This role drives data governance, advanced trending, signal detection, and provides executive-level insights to cross-functional teams, protecting patients and ensuring regulatory compliance.

The ideal candidate has 10+ years in data analytics within medical devices or biotech and expert skills in SQL, Python, R, SAS, and Power

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