Sr Statistician, Quality Assurance

Job description

PURPOSE AND SCOPE: Provides a wide range of advanced statistical expertise, guidance, and support to internal customers. Participates in the design, development, and reporting of statistical data, and responds to a broad range of statistical processes and analysis. PRINCIPAL DUTIES AND RESPONSIBILITIES: Experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. Normally receives little instruction on day-to-day work, general instructions on new assignments. Acts as a subject matter expert for statistical analysis and interpretation during meetings and audits. May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions. May escalate issues to supervisor/manager for resolution, as deemed necessary. Mentor other staff as applicable. Participates in the design, analysis and reporting of statistical data; provides consultation to investigators and internal staff on design, and statistical research approaches, requirements, and scientific standards. Works with internal customers to formalize analysis plans and reporting specifications; advises as to choice of statistical analysis strategies, sample size determinations, acceptance criteria, reliability of measurements, and identifiability of models and interpretation and presentation of statistical results. Uses a variety of advanced statistical software, methods and techniques to gather, analyze, and interpret data to derive useful information for quality data; advises and assists in the development of inferences and conclusions, as appropriate. Develops enhancements to statistical software, as appropriate, by programming new techniques; maintains knowledge of current and emerging trends in statistical analysis methodology. Prepares a variety of comprehensive statistical reports according to presentation requirements; participates in manuscript preparation to include preparation of data summaries and statistical results for internal or external publication. Oversees and coordinates the work of statistical support staff and data entry staff, as appropriate to the position, on a project, site or operational basis. Interprets data to ensure the right decisions are made based off of the results. Presents results to management, regulatory authorities, quality engineers and others as appropriate. Provides statistics support to functional groups in the organization as needed (Design Control, validations, inspections, etc.); may include verification and/or approval of statistical analysis performed by others. Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations. Authors or edits statistical reports as necessary. Assist with various projects as assigned by a direct supervisor. Other duties as assigned. Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS : The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Regularly required to talk and hear. Frequently required to stand; walk and sit, use hands to finger, reach with hands and arms; stoop, kneel, crouch, or crawl. Occasionally required to climb or balance and wear protective equipment that may include steel-toed shoes or safety glasses, lab coat, etc. Ability to lift and/or move 50 lbs. Occasionally exposed to moving mechanical parts, and wet and/or humid conditions. The noise level in the work environment is usually moderate. The employee may be exposed to bovine and human blood products. Hepatitis B vaccination is recommended. EXPERIENCE AND REQUIRED SKILLS: Bachelor's Degree required; Advanced Degree desirable 5 or more years' related Statistics and mathematical experience. American Society for Quality (ASQ) Certified Quality Engineer preferred. Must be able to prioritize responsibilities in order to maintain a balance of support in all areas and execute projects with clear objectives. Experience with computer data processing and other software used to analyze and report scientific activities. Strong oral and written communication skills. Ability to write reports, business correspondence, and procedures. Ability to update documentation through the electronic change control system. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to understand and employ mathematics and statistics at an advanced level. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Knowledge with Minitab, MATLAB, and MS office suite preferred. Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws. Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors