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SENIOR BIOINFORMATICS DATA ANALYST - POST MARKET SURVEILLANCE (REMOTE)

REMOTE, REMOTE

We seek an individual who is looking for an opportunity to work in a dynamic and progressive environment as a Data Analyst. In this role you will have the opportunity to develop and implement effective data analysis and visualization for all Post Market Surveillance product complaints within and support businesses. Activities would be in direct support of monitoring and detecting quality and safety signals associated with fielded product performance (e.g., adverse events, product malfunctions). The role ensures on-going regulatory, the quality of our products for our customers and can help serve to identify early signs of potential issues and contributes to continuous product/process improvements. You will have the ability to engage and work closely with Quality and Regulatory teams as well as the Field Service Engineers, Product Support, Research & Development, and manufacturing organizations.

Come join our team of regulatory compliance professionals who are on the frontline of investigating global product performance, assuring products are safe and effective for use for loved one's who are being diagnosed.

You are responsible for:

 

  • Managing the Post Market Surveillance trending processes and assuring proper statistical techniques are applied to all trending methods
  • Developing and deliver dashboards and data visualizations needed to optimally monitor Post Market Surveillance data to assure Patient Safety and Product Quality
  • Developing methods needed to effectively supervise PMS data to assure Patient Safety and Product Quality
  • Crafting reports for internal teams. Use graphs, infographics, and other methods to visualize data
  • Establishing tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), DOE)
  • Automating data analysis methods
  • Working with the various KPI owners to maintain oversight of all KPIs and ensuring accuracy of data reported to the leadership team
  • Assuring the data integrity of all output via appropriate verification and validation activities
  • Detailing statistical-based trending procedures and trending analysis validation in compliance with regulatory requirements
  • Developing and delivering training materials to aid teams with their understanding of statistical-based trending methods
  • Explaining statistical rationale and trending procedures during regulatory audits, if vital
  • Prioritizing requests for ad hoc data & reports
  • Translating data and trends into actions to drive business decisions
  • Build presentations and reports based on recommendations and findings
  • Help identify product trends and drive measurable insights
Qualifications:
  • Bachelor's degree (e.g., computer science, data science, social sciences, physical sciences, math, engineering, or statistics)
  • 4+ years of related work experience, ideally in a regulated environment (medical device, pharmaceutical, etc.)
  • TIBCO Spotfire analytics platform required
  • Experience with applicable software, i.e., SAS, JMP, Python, R, SQL, etc., that integrate large datasets from multiple sources
  • Experience with data management, specifically with validating and auditing data and reports from multiple systems
  • Sophisticated Microsoft Excel skills desirable (conditional formulas and formatting, charting, pivot tables, Vlookup, etc.)
  • Experience with appropriate FDA and ISO regulations.
  • Previous experience crafting custom reports/dashboards and building visualizations in analytics tools
  • Able to manage expectations with supervisors, peers, and customers
  • Experience manipulating large data sets through statistical software or other methods
  • Must have excellent written and verbal communication skills
  • Well-developed interpersonal relationship skills

Preferred Qualifications:

  • American Society for Quality (ASQ) certification, Six Sigma knowledge is desirable
KP RECRUITING GROUP
 
KP Recruiting Group was started to create a world-wide network of multi-level, highly skilled talent; that are either experts or working to become one, in their respective fields. Our process involves focusing on the talent, skills, and experience of an individual as a key indicator of the present and future value that they will bring to any organization.

In establishing a network, we are able to forge genuine relationships with talent and gain valuable insight that allows us to understand what motivates them. This data allows us to give strategic advice to our partners as they go through the process of managing their human capital.

See our jobs and apply here: https://kprecruitinggroup.catsone.com/careers/7781-General

 
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