Statistician

Kindeva Drug Delivery

ROLE SUMMARY

Statistician responsibilities include conducting full lifecycle analysis to include product requirements, activities, and design. Statistician will develop analysis and report process capabilities and trending. They will also monitor performance and quality control plans to identify improvements.

ROLE RESPONSIBILITIES

• Monitor manufacturing and production process control charts to identify, analyze, and interpret trends or patterns in complex data sets (Ppk, Cpk, Nelson Rules, Normality)
• Plan statistically significant data collection methods for specific projects, and determine the type (discrete or continuous) and sizes of sample groups
• Consulting as mathematical statistician for specific statistical problems in collecting or analyzing data, determining cause(s) of problems, and developing solutions
• Adapt statistical methods in order to solve specific problems
• Create and optimize reporting dashboards to compare product performance against predetermined quality limits
• Review technical documents to ensure compliance best practice statistical methods
• Develop data monitoring strategies that optimize efficiency, reliability and quality
• Develop and test experimental designs, sampling techniques, Measurement Systems Analysis (MSA) and other analytical methods
• Analyze and interpret statistical data in order to identify significant differences and trends in relationships among sources of information
• Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.

 BASIC QUALIFICATIONS

• Strong statistical skills with the ability to identify, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy

• Experience with Acceptance Sampling Plans, OC Curves, Confidence Intervals and Equivalence Testing
• Knowledge of statistics and experience using statistical packages for analyzing datasets (R, Python, SPSS, SAS, Minitab, Excel etc.)
• Ability to create and maintain data visualization and summarization reports and dashboards that address business initiatives
• Extensive experience in troubleshooting and documenting changes in statistical programming environments
• Working knowledge of data models, mining, and segmentation techniques
• The ability to choose the right mathematical methods or formulas to solve a problem.
• Master's degree in statistics, data science, mathematics, or equivalent master's degree program with a focus on statistical methods
• Minimum of 5 years of experience working as a statistician, or in a similar role

PREFERRED QUALIFICATIONS

• Experience in the Pharmaceutical or medical device industry (e.g., cGMPs, FDA CFR 211/820, and ICH 13485)

• Expert proficiency in R/RStudio or Minitab

• CQE or Master Black Belt
• Experience visualizing/presenting data for stakeholders using: Periscope, PowerBI, Spotfire, Business Objects, D3, ggplot, Tableau, Shiny, etc.
• Adept at queries (e.g., SQL/MySQL), report writing (e.g., Markdown, LaTeX), and presenting findings

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