Represents Biostatistics at Global Clinical Subteams; Interacts with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials, as well as ensure the clinical program is appropriately designed; Guides staff in the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc; Identifies the need for new process improvement initiatives, and leads working groups to solve the process gaps. Sets timelines and expectations for the deliverables. Authors new/revised SOPs and contributes to cross-functional EPIC workstreams
Requirements:
PhD or equivalent degree in statistics/biostatistics with >8 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >13 years’ experience; Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies
Text:
Director, Biostatistics - Early Clinical Development Represents Biostatistics at Global Clinical Subteams; Interacts with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials, as well as ensure the clinical program is appropriately designed; Guides staff in the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc; Identifies the need for new process improvement initiatives, and leads working groups to solve the process gaps. Sets timelines and expectations for the deliverables. Authors new/revised SOPs and contributes to cross-functional EPIC workstreams PhD or equivalent degree in statistics/biostatistics with > 8 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with > 13 years’ experience; Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies
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