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Principal Scientist, Biostatistics, Late-Stage Clinical Development

Merck · Rahway, NJ +1 more

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BiometricsFull-time$191k–$300kCompany career page

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Role summary

Principal Scientist role in biostatistics supporting late-stage clinical development at a major pharmaceutical company. The position involves designing and analyzing clinical trials, leading statistical teams, and ensuring regulatory compliance for drug and vaccine development programs.

What they're looking for

  • Ph.D. in Biostatistics or Statistics preferred; MS acceptable with 9+ years experience
  • Minimum 6 years relevant work experience with Ph.D. or 9 years with MS
  • Expertise in statistical methodology, experimental design, and clinical trial analysis
  • Knowledge of worldwide regulatory requirements and drug approval processes
  • Experience designing and analyzing Phase II/III clinical trials
  • Proficiency with biostatistical computing software and data management systems
  • Scientific leadership experience in clinical trial design and regulatory submissions

What you'll be doing

  • Develop and coordinate biostatistical support for pharmaceutical development projects
  • Lead teams of statistical and programming staff assigned to clinical development programs
  • Design study protocols and data analysis plans using appropriate statistical methodologies
  • Identify technical problems in trial design, conduct, and analysis; propose and implement solutions
  • Analyze clinical trial data and prepare reports communicating results to stakeholders and regulators

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