· Provide statistical analyses and recommendations to support pharmaceutical manufacturing and regulatory filings.
· Set specification limits, alert limits, process control limits and pharmaceutical product shelf-life.
· Recommend test designs, sampling requirements and data collection strategies to help with predictive modeling as well as hypothesis testing.
· Organize and reconcile data from disparate sources in formats that are suitable for data analysis presentable to regulatory authorities.
· Analyze historical manufacturing, product stability and experimental data, in support of hypothesis testing, understanding the sources of variability, setting limits, estimating product shelf-life, analytical method and process validation, and compliance requirements such as Annual Product Review.
· Present data in understandable forms of plots, charts.
· Document the statistical conclusions and recommendations in technical reports, presentations or internal memoranda.
· Carry out these independently as well as in collaboration with the senior staff members within the statistics group.
Qualifications
· B.S or M.S in statistics or mathematics or related discipline with knowledge or experience in using statistical distributions, design of experiments (DOE), linear and multiple linear regressions, generalized linear models, software applications such as JMP, Minitab and R, developing custom software code to perform special statistical calculations, preferably in pharmaceutical industry applications.
· Should be able to use Microsoft applications such as Word and Excel, including Excel functions, with ease.
· Good communication skills and previous experience in writing formal technical reports.
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