Statistician

FLSA Status: Exempt  

 

Position Summary: 

The primary function of this position is to provide statistical expertise to support the development of ICU products and to solve plant or customer originated related product and process concerns. This involves the use of statistical tools and optimized sampling. Identification of appropriate acceptance criteria, experimental design, and appropriate data analysis to conclusion will often determine whether or not a project is feasible, defendable to regulatory agencies, or commercially justified. Without the correct analysis, erroneous conclusions can be made, incorrect strategic decisions can result, and costs of correcting these errors can rise dramatically. Poor statistical understanding leads to manufacturing process plagued with inefficiencies or the product may failing to meeting the quality, purity, potency and identity specifications throughout shelf-life. This can impact a wide range of project types, including cost reductions, raw material replacements, and new product development. This role will provide subject matter expertise in the area of statistical analysis for site Technical, Quality, Engineering and Operations leadership and technical teams to support development decisions and continuous improvement initiatives site wide. 

Essential Duties & Responsibilities:

• Act as a plant resource to create and maintain processes for statistically evaluating data used in existing products for cost reductions, performance improvements or which enable the development of new products. Use appropriate statistical tools to define problems and propose solution approaches to issues posed by internal commercial, operational, quality, or external regulatory requirements. Statistical tools include, but are not limited to: statistical design of experiments, regression analysis, analysis of variance, distribution fitting and prediction, confidence intervals, acceptance sampling, population modeling, attribute/categorical analysis, capability analysis, nonparametric methods, and statistical process control charting.

• Analyze and interpret information, whether it be test data, published scientific papers and patents or raw material vendor-supplied information. Demonstrate the ability to absorb and reduce such information to practical actions and recommendations.

• Provide statistical assistance in setting up sampling plans for evaluation of new products and amended processes.  

• Provide statistical expertise to site Technical, Quality, Engineering and Operations leadership to aid in the strategic and tactical decision making process.

• Communicate effectively (verbally and in writing) across disciplines and with internal and external stakeholders on technical statistical questions.  

• Plan, conduct and rigorously document analyses in technical memos and reports in support of product and process development, refining the manufacturing process for existing products, cost reduction, or and process improvement of existing products. 

• Ensure that statistical analyses meet the requirements of all relevant regulatory agencies. Act as the SME on fundamental statistical questions with internal and external regulatory representatives 

• Characterize/evaluate existing manufacturing and analytical testing methods and evaluate potential improvements.  

• Interface with ICU corporate and site technical resources to leverage the advantages of their perspective and assure project conformance to applicable ICU standards, current best practices and Quality Standards.

• Maintain technical skills in the latest techniques for statistical analysis as applied to cGMP pharmaceutical manufacturing.

• Provide statistical support to root cause investigations, troubleshooting efforts and product performance issues.

• Perform other related duties as assigned or required.

Knowledge, Skills & Qualifications:

• The candidate should have problem solving skills and the ability to correlate the statistical findings with potential process improvement opportunities and experience in planning and interpreting the results of Design of Experiments (DOE).

 Education and Experience: 

• Requires a Bachelor’s degree in statistics or biostatistics

• ASQ Certified Quality Engineer and Six Sigma Green Belt preferred.

• Requires 3-5 years of statistical analysis experience in the pharmaceutical or equivalently regulated field (aviation, food, etc.). Experience in a product/process development environment desired.

• Superior statistical process control and problem solving skills required.  

• Must have project management experience or project development experience with demonstrated successful results.  

• Experience with data analysis computer tools, word-processing, spreadsheet and presentation software required (e.g. Minitab, MS Word, Excel, Access, Infinity QS, JMP).

• The incumbent should have experience in implementing and maintaining a statistical process control program for a manufacturing operation.  

Minimum Qualifications:

• Must be at least 18 years of age

• Must pass pre-employment drug screen and background check

Travel Requirements:

• Typically requires travel less than 5% of the time

 

Physical Requirements and Work Environment: 

• Generally office environment.  

• Cleanroom and/or manufacturing or laboratory environment to support data collection, troubleshooting and application of recommendations.

• Ability to work night, weekend and holiday hours as required by projects and by support for 24/7 operations

We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.