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Title:Sr. Biostatistician
Salary:Open
Experience:6+
Location:MD - Gaithersburg

Description:
This position will be report to the Biostatistics therapeutic head and function independently as a lead statistician for one or more clinical development programs to provide statistical support for development planning and clinical trials of Phase I through Phase III. Apply statistical principles and techniques to a wide range of problems in the clinical trial environment and contribute advanced knowledge of statistics and regulatory guidelines to ensure the most optimized statistical methodology to be used in clinical development.

Responsibilities:
  • Participate and provide strategic, statistical and scientific inputs into clinical development planning or jointly author the plans with Medical Directors.
  • Participate therapeutic area strategic and tactical meetings, contribute to strategic planning to ensure statistically optimized clinical development plans, and provide presentations if needed.
  • Be responsible for the statistical designs of clinical trial and create statistical sections for study synopses and protocols.
  • Lead Biostatistics activities for the regulatory submission documents including summaries of clinical safety and efficacy of BLA/NDAs if needed, review protocols, study reports, and submission documents.
  • Create statistical documents including CRF specifications document, statistical analysis plan, and statistical programming plan with templates for tables, listings and graphs, etc.
  • Provide statistical input/contributions to regulatory submissions and interactions, response to questions from the FDA and Advisory Committee meetings if needed.
  • Represent biostatistics in project team meetings and other project activities.
  • Present statistical considerations at investigator or other external meetings.
  • Perform statistical analyses, generate reports and create statistical text for clinical study reports, clinical publications and other communications.
  • Participate in the preparation, review and approval of IVRS specification, case report forms, and data edit spec.
  • Oversee the statistical related work of outsourcing partners and vendors at the protocol level.
  • Lead and project-manage intra-department statistical teams regularly or for specific project/research as needed.
  • Contribute toward literature review and statistical methodology research on statistics or clinical trial methodology for statistical issues raised in clinical development.
  • Provide internal presentations on topics in either statistical methodology or statistical considerations/solutions to issues in trial design and analysis.

Requirements:
  • MS with 6 years or PhD with three years in statistics or other related field with high statistical content

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