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Position: Associate Director, Biostatistics - Inflammation
Institution: Gilead Sciences, Inc.
Location: Foster City, California, United States
Duties: Provides Statistical leadership to clinical trials: developing trial design options and providing high quality decision support; Is expected to oversee and contribute to the completion of all technical and operational statistical activities for the clinical trials and to defend statistical aspects with regulatory agencies; Works collaboratively with Statistical Programming, Clinical Development, Clinical Data Management, Global Drug Safety, Regulatory and Project Management to meet project deliverables and timelines for statistical data analysis and reporting
Requirements: 10 years + (Bachelors); 8+ years (Masters); 6+ years (PhD) of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO); 5+ years of industry experience in the statistical analysis of clinical trial data using statistical software; Extensive hands-on experience in drug development including design and analysis of phase 2/3 trials and active participation in NDA/BLA filing through label negotiation
   
Text: Associate Director, Biostatistics - Inflammation Provides Statistical leadership to clinical trials: developing trial design options and providing high quality decision support; Is expected to oversee and contribute to the completion of all technical and operational statistical activities for the clinical trials and to defend statistical aspects with regulatory agencies; Works collaboratively with Statistical Programming, Clinical Development, Clinical Data Management, Global Drug Safety, Regulatory and Project Management to meet project deliverables and timelines for statistical data analysis and reporting 10 years + (Bachelors); 8+ years (Masters); 6+ years (PhD) of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO); 5+ years of industry experience in the statistical analysis of clinical trial data using statistical software; Extensive hands-on experience in drug development including design and analysis of phase 2/3 trials and active participation in NDA/BLA filing through label negotiation
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