Job Summary
The position serves as the Regional Manager, subject matter expert, and single point of contact for BU NAM (Business Unit North America) managing the statistical data analytics and metrics programs for all Production Units (PU) as well as Third Party Manufacturing / Distribution Center (TPM/DC) operations. The incumbent ensures harmonization of the statistical approach for all PUs, TPM/DCs, and alignment with global and regulatory authority requirements, and coordinates cross-site best practices for trending, data analysis, and management review metrics.
The individual ensures sites accurately analyze data and approves the statistical methodology used in scientific studies, statistical process controls, and other related tasks. The position is responsible for creating and supervising a system for the monitoring of data collection and the use of mathematical and statistical modelling, as well as providing strategic advice on how best to apply data analysis results. The position requires approximately 10% of domestic travel.
Salary Range: $90,816-$130,000/year + 10% Bonus
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Responsibilities

Position Duties

• Work with Fresenius Kabi sites regionally and globally to facilitate data collection for analyses and metrics.
• Confirm statistical data analyses and metrics are in compliance with regulatory agency guidelines and global procedures; this includes all statistical analyses performed by other departments.
• Communicates analysis results and their implications in a manner that will be understood at all levels.
• Enhance and extend data analysis to support additional data driven management decisions.
• Ensure methods used comply with GMP, specifically data integrity standards, and ensure consistency in reporting across BU NAM.
• Schedule and lead meetings to review statistical conclusions.
• Support all departments by providing statistical approaches and clarity around possibilities given current knowledge and technology.
• Provide project level analysis plan for use as a template for individual studies.
• Review/approve study protocols that utilize data analysis, statistical analysis plans, or employ statistical methodologies.
• Represent statistical programs in regulatory interactions.
• Ensure all data sources are optimized that are utilized in decision making.
• Ensure the integration of data management systems into the overall statistical approach.
• Perform analyses to drive site and regional initiatives supporting Quality, Production, and Operational Excellence.
• Responsible for tracking and trending activities both within KabiTrack / TrackWise, SAP, and from exterior data sources and being proactive in identifying any adverse trends.
• rAll employees are responsible for ensuring compliance with company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems, as per roles and responsibilities.
• Perform other duties as directed by management.

Requirements

• 4-year college degree in a technical field with a focus on statistical analysis is required.
• 5+years’ related work experience.
• Advanced computer skills required.
• Familiarity with Minitab, Visual Basic, R, Python, Tableau, and Microsoft Office applications preferred.

Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status

• Work with Fresenius Kabi sites regionally and globally to facilitate data collection for analyses and metrics.
• Confirm statistical data analyses and metrics are in compliance with regulatory agency guidelines and global procedures; this includes all statistical analyses performed by other departments.
• Communicates analysis results and their implications in a manner that will be understood at all levels.
• Enhance and extend data analysis to support additional data driven management decisions.
• Ensure methods used comply with GMP, specifically data integrity standards, and ensure consistency in reporting across BU NAM.
• Schedule and lead meetings to review statistical conclusions.
• Support all departments by providing statistical approaches and clarity around possibilities given current knowledge and technology.
• Provide project level analysis plan for use as a template for individual studies.
• Review/approve study protocols that utilize data analysis, statistical analysis plans, or employ statistical methodologies.
• Represent statistical programs in regulatory interactions.
• Ensure all data sources are optimized that are utilized in decision making.
• Ensure the integration of data management systems into the overall statistical approach.
• Perform analyses to drive site and regional initiatives supporting Quality, Production, and Operational Excellence.
• Responsible for tracking and trending activities both within KabiTrack / TrackWise, SAP, and from exterior data sources and being proactive in identifying any adverse trends.
• rAll employees are responsible for ensuring compliance with company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems, as per roles and responsibilities.
• Perform other duties as directed by management