Provide Statistical leadership to late-stage oncology clinical trials: developing trial design options and providing high quality decision support; Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head; Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting
Requirements:
12 years + (Bachelors); 10+ years (Masters); 8+ years (PhD); 4+ years (MD) of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO); Industry experience in the statistical analysis of biomedical data using statistical software; Extensive hands-on experience in oncology drug development including design and analysis of phase 3 oncology trials and active participation in NDA/BLA filing through label negotiation
Text:
Director, Biostatistics - Oncology Provide Statistical leadership to late-stage oncology clinical trials: developing trial design options and providing high quality decision support; Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head; Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting 12 years + (Bachelors); 10+ years (Masters); 8+ years (PhD); 4+ years (MD) of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO); Industry experience in the statistical analysis of biomedical data using statistical software; Extensive hands-on experience in oncology drug development including design and analysis of phase 3 oncology trials and active participation in NDA/BLA filing through label negotiation
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