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Statistician III
Ref No.: 18-07945
Location: Andover, Massachusetts
Job Description: Non-clinical biostatistician to provide statistical consultation and data analysis support to biotechnology derived drug manufacturing operations by interacting closely with scientists, engineers, technicians and other statisticians. Provides in-depth data analysis for the evaluation of processes and tests methods. Establishes criteria for evaluating system components and overall system performance by tracking and trending data using control charts. Provides general statistical guidance and training to technical teams. Delivers technical presentations as required. Ability to communicate and write analysis conclusions clearly in technical reports is a key to be successful in this position. Positon is at Pharmaceutical, Andover, MA. A local resident from greater Boston area is preferred. Years of Experience 5-7.

• Estimate analytical measurement and manufacturing process variabilities
• Recommend quality control (QC) assay limits and evaluate assay performance
• Assess drug specification limits and process control limits
• Recommend test designs and acceptance criteria for analytical method validations, critical reagent qualifications and comparability studies
• Provide statistical input to standard curves, reference standards and replicate sample sizes of analytical methods and bioassays
• Perform stability analysis of drug products, and estimate stability profiles and shelf lives
• Support investigations of deviations, and unusual and out of specification results
• Recommend environmental monitoring limits and rules
• Provide input to SOPs, test protocols, study reports, regulatory submissions and queries
• Author formal reports of statistical conclusions and results
Position Comments visible to MSP and Supplier: Good grasp of project scopes, excellent verbal and written communication skills are important