Principal Biostatistician

  • Contract
  • Remote

SimulStat

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Remote, contract to the end of the year (12/30/22), renewable

The Principal Biostatistician provides study- and project-level statistical support for clinical studies in assuring appropriate design, analysis and interpretation of results, and contributing to regulatory submissions and negotiations.

  • Perform independently as a Project Statistician for routine projects or projects with BI experience.
  • Provide statistical support for research and development Clinical studies at the study and project level, & in compliance with BI/regulatory guidelines, including:
    • Contribute to design of Clinical studies of increasing complexity in alignment with appropriate statistical methodology, project objectives and regulatory standards, conforming to R&D, marketing and/or publication strategies. 
    • Manage study parameters to provide efficient, effective and optimally-sized studies which will provide sufficient data for regulatory submissions.
    • Prepare/review reports for clinical trials of moderate complexity for registration of drugs and biologics, publications and management to ensure appropriate analyses and interpretation of results.
  • Evaluate alternative experimental designs, analysis methods, and statistical theory as relevant to BIAH projects. Pursue and apply industry innovations and comply with shifts in regulatory landscape. Participate in internal or external working groups.
  • Provide statistical expertise to the Biostatistics group regarding technical, scientific, or industry-related topics that could be applied for more efficient and effective use of resources. Align proactively with global colleagues where appropriate.
  • Comply with company SOPs and relevant regulatory guidances at national and international levels. Act at all times within industry, company, and statistical standards and ethics  Apply solid understanding of relevant regulations governing the Animal Health industry.

Responsibilities and Qualifications:
 

The incumbent must:

    • Balance and prioritize project work according to business objectives.
    • Ensure work is compliant with applicable regulatory requirements which vary by geographic region and agency.
    • Interact with counterparts in other divisions and regions.
    • Research, justify, and apply innovative approaches when needed to analyze complex data or solve problems. 
  • They will participate on project and clinical study teams, independently representing Biostatistics group perspectives. They will contribute to Biostatistics group positions, meet and negotiate with members of other functions to guide study design, ensure compliance and accurately interpret and report statistical principles and analysis results; will also contribute statistical expertise in other areas as Company business needs require.
  • Consistently applies a solid foundation of statistical scientific/technical knowledge; exhibits strong communications skills, accepts guidance, and demonstrates motivation for contribution, independent work, learning and development.
  • Expertise in particular scientific disciplines related to animal health or pharmaceutical/biological industry is highly desirable, preferably including clinical trial design and analysis in the pharmaceutical/biological industry.
  • Required software proficiency: SAS, R, MS Office applications. In particular, demonstrated ability in SAS programming and R, supporting the analysis of data using linear mixed models, generalized linear mixed models, survival and categorical methods.
  • Knowledge of statistical theory and application of statistical methodologies in study design and data analysis is required.
  • Solid understanding of applicable regulations governing the Animal Health industry.

Experience reflecting ability to:

    • Conduct power calculations, assess experimental designs, conduct analyses, and provide interpretation of results.
    • Work successfully in a team environment to accomplish goals.
    • Communicate statistical information to non-statisticians
    • Work independently and with other Biostatisticians to determine appropriate statistical analysis methods and efficient experimental designs to address project objectives.
    • Manage multiple tasks with differing priorities to meet time lines.
    • Negotiate among multiple parties to find mutually reasonable outcomes.
    • Interact with regulatory authorities on statistical issues at the project level.
    • Manage project(s) from a statistical perspective.
    • Work with researchers in determining the most effective and efficient designs to address project objectives

Education / Experience:

  • Doctoral (preferred) or Masters degree in Statistics/Biostatistics
  • Recommended 5 (Doctoral) / 9 (Masters) years of industry or relevant experience
  • Experience in the pharmaceutical, animal health, or agricultural science industry is highly desirable, preferably including clinical trial design and analysis in the pharmaceutical/biological industry.

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