Biostatistician​/statistician

Responsibilities

• 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 suitable for data analysis, presented to regulatory authorities.
• Analyze historical manufacturing, product stability, and experimental data in support of hypothesis testing, understanding 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 such as plots and charts.
• Document the statistical conclusions and recommendations in technical reports, presentations, or internal memoranda.
• Carry out these tasks independently and in collaboration with senior staff members within the statistics group.

• B.S. or M.S. in statistics, mathematics, or a related discipline with knowledge or experience in using statistical distributions, design of experiments (DOE), linear and multiple linear regressions, generalized linear models, and software applications such as JMP, Minitab, and R; experience developing custom statistical code, preferably in pharmaceutical industry applications.
• Ability to use Microsoft applications such as Word and Excel, including advanced Excel functions, with ease.
• Good communication skills and previous experience in writing formal technical reports.

All your information will be kept confidential according to EEO guidelines.