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Title:Biostatistics Manager
Salary:Open
Experience:4-6
Location:CA - South San Francisco

Description:
Contribute to the continuous improvement of Global Biostatistics. Create statistical text for study concept documents and protocols (study design, endpoints, sample size, methods for analysis).

Responsibilities:
  • Review and approve randomization specifications
  • Create statistical analysis plans
  • Create templates for tables, listings and graphs
  • Review and approve dataset specifications
  • Review and approve key study-related documents produced by other functions (e.g. CRFs, Data Management Plans etc)
  • Write, test, validate and execute software programs to produce SDF datasets and tables, listings and graphs (statistical analysis outputs) for inclusion within CSRs, ISS / ISE, publications and other communications
  • Participate in the finalization of protocol deviations and analysis sets
  • Create statistical reports
  • Create statistical text for CSRs, clinical publications and other communications
  • Plan and execute statistical review and QC of CSRs, clinical publications and other communications
  • Plan and execute statistical review and QC of ISS/ISE
  • Oversee the work of outsourcing partners and vendors at the product level
  • Create Requests for Proposals (RFPs) from outsourcing vendors for statistical services
  • Contribute to decisions on selection of outsourcing partners and vendors-Lead and/or participate in the development and review of Company Policies, SOPs and other controlled documents
  • Participate in study and systems audits by CQA and external bodies, and respond to audit questions and findings
  • May manage and develop a small number of statistical staff
  • Participate in the recruitment of statistical staff
  • Provide input to and participate in intra-departmental and global Biostatistics meetings
  • Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field
  • Promote and communicate statistical awareness and the role of the Biostatistics department (internal/external; scientific/process)

Requirements:
  • Degree in Statistics
    • 6 years Scientific career experience without a PhD
    • 4 years Scientific career experience with a PhD
  • Statistical Methodology and Applications within Drug Development
  • Drug Development Process Operations
  • Use of Biostatistical Software within Drug Development
  • Statistical Analysis
  • Clinical Trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
  • Drug Development (Pre-clinical Development, Clinical Development, Medical Affairs)
  • Project Planning and Management
  • Communication of statistical information (written and oral)
  • Development of policies and SOPs

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