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Director, Biostatistics

Posted 2024-11-07

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💎 Seniority level: Director, 10+ years with PhD or 12+ years with MS

📍 Location: United States

🔍 Industry: Biopharmaceutical

🏢 Company: Entrada Therapeutics

🗣️ Languages: English

⏳ Experience: 10+ years with PhD or 12+ years with MS

🪄 Skills: LeadershipData AnalysisPeople ManagementCross-functional Team LeadershipData analysisCommunication SkillsAnalytical SkillsCollaboration

Requirements:
  • PhD with 10+ years or MS with 12+ years of relevant statistical analysis roles in the biotech/pharmaceutical industry.
  • Experience with a broad array of statistical approaches and proposing novel approaches.
  • Demonstrated track record in various disease indications and appropriate statistical requirements.
  • Experience in supporting responses to health authorities (FDA, EMA).
  • Strong vendor management and oversight experience.
  • Proficiency in statistical analysis software (SAS and R) and sample size calculation software.
  • Excellent verbal and written communication skills.
Responsibilities:
  • Responsible for leading statistical strategy for assigned drug programs, including input to clinical development plans and protocols design.
  • Accountable for oversight of the production of biostatistics deliverables.
  • Serve as a key leader in the clinical product team, providing statistical strategy and inputs in various study documents.
  • Author/review the statistical analysis plan for clinical trials.
  • Define/review the randomization procedures and oversight.
  • Review study documentation to ensure statistical requirements are met.
  • Oversee outsourced statistical CRO activities and deliverables.
  • Support the development of department strategies.
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