Biostatistics Director

1 week ago


Redwood City, California, United States Meet Full time
Job Title: Director Biostatistics

Meet is dedicated to creating innovative pharmaceutical therapies to improve healthcare standards and address unmet medical needs globally. With over 100 years of scientific expertise and a presence in over 20 countries, our teams worldwide leverage our legacy of innovation and robust pipeline of promising new medicines to help people.

Job Summary

The Director Biostatistics will lead complex studies in study design, statistical analysis, and interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision.

Key Responsibilities

  • Protocol Development and Statistical Analysis: Lead statistical activities for complex studies, including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation, and CSR input and review.
  • Drug Development Strategy: Provide input to multiple aspects of the development plan to ensure study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements, and deliver the pre-specified product profile.
  • CRO/Vendor Oversight: Review CRO/vendor proposal and budget, establish procedures through regular interaction, set expectations on deliverables and timelines, and guide CRO biostatistician and statistical programmers on complex studies.
  • Global Health Authority Interaction/Negotiation: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document.
  • Global BDO Strategy to Improve Drug Development: Participate in and lead moderately complex initiatives to improve the harmonization and efficiency of drug development, leading to cost savings and shortened timelines for the company.

Qualifications

Successful candidates will have a Master's degree in statistics or biostatistics and 2 years of Oncology trial support experience. A PhD in statistics or biostatistics is preferred.



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