Biotech Senior Principal Biostatistician – REMOTE (Contract)

Precision Life Sciences - Boston, MA

Precision Life Sciences is working with a client, in the life science / biotechnology industry, for a contract, remote Senior Principal Biostatistician. The position will provide oversight on clinical studies and provide statistical support on the development of in-house clinical studies and projects. The positional is responsible for designing, implementing, and reporting in a quality, timely and accurate manner, the statistical processes in clinical trials, including applying state of the art concepts and tools to the interpretation of clinical trial data when appropriate.

Specific Responsibilities:

 

Provide statistical support on clinical studies, including:

  • ­Representing the Biostats group on clinical study teams,­ providing input on the development of study protocols (choice and implementation of design, sample size estimation, statistical analysis strategy),­ write statistical analysis plans with programming specifications and other clinical documents
  • Manage the development of statistical outputs and documents with the programming team
  • ­Ensure the interpretation of statistical results in clinical documents and provide input on publications
  • Participate in the preparation of responses to questions from regulatory agencies
  • Responsible for interacting with regulatory authority personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations.
  • Provide oversight of statistical tasks on studies that are outsourced to partners
  • Responsible for the discussion and implementation of rigorous, informative, and when appropriate, innovative study designs, statistical models, and analysis methodologies that optimally address the research objectives by establishing the efficacy and safety of the compound
  • Develop, implement, or advise on appropriate new statistical developments by keeping abreast of current issues and developments in statistical theory and application
  • Leads or contributes to departmental process improvement initiatives and development/revision of SOPs
  • Maintain awareness of industry standards, regulatory requirements, departmental guidelines, and SOP. Within the area of control, update procedures or practices as needed to remain in compliance. Procedures and practices meet industry standards and are consistent with internal SOP.

    Skills and Education:

    Mandatory:

    • M.S. in Biostatistics or a closely related field is required.
    • Ph.D. in Biostatistics or a closely related field is strongly preferred.
    • Broad knowledge and superior understanding of advanced statistical concepts and techniques
    • Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
    • Ability to determine appropriate designs and analyses for clinical trials.
    • Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs.
    • Must have a working knowledge of statistical analysis plans including the report outline, mock-up tables, graphs, and data listing shells and appendices.
    • Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed.
    • Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed-upon decisions yet remains flexible should priorities change (judgment and decision making)

      The position must demonstrate

  • Excellent verbal and written communication skills
  • Experience in the analytical evaluation of analysis of clinical study data
  • Exceptional organizational skills and attention to details
  • Project management skills and familiarity with GCP and ICH guidelines

    The position must be able to

  • Manage multiple projects with competing priorities
  • Maintain expertise in statistical analysis methods
  • Show competency in leadership and mentoring other team members
  • Ability to work with minimal supervision as well as in a team
  • Communicate statistical issues across the multi-disciplinary team
  • Apply internal standards (including CDISC) and regulatory requirements/guidance
  • Work in a team environment

 

Desirable:

  • Generally, has 6+ years of relevant industrial or related academic experience, including experience in Oncology and interactions with regulatory bodies for master’s degree and 4+ years for a Ph.D. degree


Posted On: Wednesday, July 20, 2022



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