Clinical Operations

  • location: Andover, MA
  • type: Contract
  • salary: $56.29 - $66.22 per hour

job description

Clinical Operations

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Job Title: Statistician III

Job Summary

  • 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. Position is in Andover, MA. A local resident from greater Boston area is preferred. Years of Experience 5-7.
Job Responsibilities

  • Estimate analytical measurement and manufacturing process variabilities
  • Recommend quality control (QC) assay limits and evaluate assay performance
  • Assess drug specification limits and process control limit
  • 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
Education & Qualifications

  • MS or PhD in statistics, mathematics or related discipline
  • Prior experience in pharmaceutical industry under cGMP environment is preferred
  • Knowledge of SPC charts, design of experiments, hypothesis testing, statistical modeling (linear and non-linear regression, ANOVA), etc.
  • Familiarity with prediction, confidence and tolerance intervals, data transformations, process capability indices and acceptance sampling standards
  • Proficiency in statistical software packages (e.g., JMP, R, MINITAB and SAS) and Microsoft Office (Excel functions, VBA, Word and PowerPoint) under Microsoft Windows environment
  • Knowledge of cGMPs, FDA/EMA and other regulatory guidelines (e.g., ICH, USP, EP) as applied to drug manufacturing
  • Experience in authoring technical reports or professional journal articles
  • Good grasp of project scopes, excellent verbal and written communication skills are important

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
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