Serve as a statistical consultant for other members of the department and staff members from other Biostatistics departments within the company. Maintain knowledge and awareness of developments in Biostatistics and clinical trial methodology, and regulatory requirements that impact analyses. Represent clients at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee. May participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication, as approved. May participate as high level lead biostatistician on major project(s) including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or new drug application (NDA) sections, as required. Provide advanced technical expertise for internal and external clients. Assist and contribute to governance structures where relevant
Requirements:
Bachelor's Degree Biostatistics or related field and 12 years relevant experience including 6 years experience managing staff Req Or; Master's Degree Biostatistics or related field and 12 years relevant experience including 6 years experience managing staff; Typically requires 12+ years relevant experience including 6 years experience managing staff or Equivalent combination of education, training and experience
Text:
Sr. Dir, Biostatistics Serve as a statistical consultant for other members of the department and staff members from other Biostatistics departments within the company. Maintain knowledge and awareness of developments in Biostatistics and clinical trial methodology, and regulatory requirements that impact analyses. Represent clients at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee. May participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication, as approved. May participate as high level lead biostatistician on major project(s) including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or new drug application (NDA) sections, as required. Provide advanced technical expertise for internal and external clients. Assist and contribute to governance structures where relevant Bachelor's Degree Biostatistics or related field and 12 years relevant experience including 6 years experience managing staff Req Or; Master's Degree Biostatistics or related field and 12 years relevant experience including 6 years experience managing staff; Typically requires 12+ years relevant experience including 6 years experience managing staff or Equivalent combination of education, training and experience
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