Principal Biostatistician CPS

США, Индиана, Indianapolis

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Summary

A seasoned professional with wide-ranging experience.  Deals with diverse and often times complex issues, where analysis may require in-depth evaluation of many factors. Exercises judgment in evaluating methods and may determine criteria for obtaining solutions. May coordinate the activities of other employees. Networks with senior internal and external personnel in area of expertise as well as some key contacts outside area of expertise.

Leads the development of statistical strategies involved in the planning/execution of test method development & design verification/validation activities.  Performs statistical design, modeling, and analyses. Interprets the statistical relevance and may assist in the interpretation of clinical relevance of study data and makes recommendations to management regarding product claims. Participates on various project teams as an advisor/SME ensuring proper use of statistical methodology & interpretation of clinical results. Specialized/in-depth comprehensive knowledge and experience in the field of data analysis and interpretation is needed. 

Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

What you do

  • Provides expertise in statistical techniques and predictive methods to characterize processes for optimal control.
  • Responsible for the selection and implementation of correct methods and models for analyses.
  • Provides mentoring, coaching, training and/or guidance as required.
  • Leads and participates in technical initiatives targeted at reductions in test method variability and improvement of product quality.  Provides statistical problem solving expertise to resolve manufacturing issues and conduct data analysis to determine process trends or shifts.
  • Provides statistical support to other functional areas as needed.
  • Drives functional software selection and standardization.

Who you are

  • Bachelor’s degree in Mathematics, with 7 years statistics experience or Master’s degree with 5 years statistics experience or PhD with 3 years statistics experience
  • Expertise in medical diagnostics, pharmaceuticals, or clinical lab setting using applied statistics
  • Advanced computer skills with experience using applicable software applications
  • Knowledge of statistics as utilized by regulatory agencies, laboratories, or other professional organizations
  • Excellent technical writing, oral communication, negotiation, interpersonal, planning, and organization skills
  • Ability to work independently

Preferred

  • Has a pro-active mind set in the collaboration with the study team
  • Is proficient in programming with R (mandatory)
  • Is familiar with regulatory requirements for planning and processing clinical studies, ideally with practical experience
  • Is willing to take occasional business trips (10%) e.g. to Germany and Switzerland
  • A motivational letter would be highly appreciated.

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