Table of Contents

As the demands of research projects vary widely in scope and complexity, defining levels of support—ranging from extensive to very limited involvement—becomes crucial. Each level not only clarifies the roles and responsibilities of biostatisticians but also ensures that the project’s needs are adequately met.

Why Define Levels of Support

  1. Tailored Expertise for Project Needs: Different research projects require varying degrees of statistical expertise. By categorizing involvement levels, organizations can effectively match biostatistical resources with the specific needs of a project. For instance, projects that require methodological development—such as designing innovative statistical models or handling intricate study designs—benefit greatly from the Extensive Involvement level, where statisticians lead and shape the analytical framework. This tailored approach ensures that the right expertise is applied where it’s most needed, enhancing the overall quality and reliability of the research.

  2. Efficient Resource Allocation: When biostatisticians are assigned roles based on their level of involvement, it allows for better resource management. For example, a project requiring only routine statistical analyses may not need a full-time biostatistician leading methodological developments. By defining a Regular Involvement level (15% FTE), organizations can allocate biostatisticians effectively, reserving more intensive support for projects that truly warrant it. This efficiency not only optimizes costs but also helps maintain a balanced workload among team members.

  3. Clear Communication and Expectations: Defining levels of involvement establishes clear communication channels and expectations between researchers and biostatisticians. When a biostatistician’s role is clearly articulated, all parties involved understand what to expect in terms of support, contributions, and deliverables. For instance, in a Limited Involvement scenario (10% FTE), where the biostatistician primarily offers consultation and minimal analysis, the Principal Investigator (PI) knows that they need to prepare for self-directed statistical work. This transparency helps prevent misunderstandings and fosters a collaborative environment.

  4. Facilitating Professional Development: When biostatisticians are aware of their expected level of involvement, it provides a framework for professional growth. Those in Extensive Involvement roles have opportunities to lead, innovate, and develop advanced methods, while those in Very Limited Involvement roles (5% FTE) can gain exposure to different projects and understand the demands of higher levels of engagement. This structure allows biostatisticians to gradually build their skills and experience, enhancing their overall competency and career progression.

  5. Ensuring Quality and Accountability: By establishing specific levels of involvement, organizations can uphold high standards of quality and accountability. Each level comes with distinct responsibilities and expected contributions, making it easier to assess performance and outcomes. For instance, a biostatistician actively leading publications in the Extensive Involvement category is accountable for the rigor of the methodologies and analyses presented. In contrast, those in Limited or Very Limited Involvement roles can focus on providing essential insights without the pressure of full authorship. This tiered approach ultimately leads to better research quality and credibility.

  6. Adaptability to Project Dynamics: Research projects are often dynamic, with changing requirements as they progress. Having defined levels of involvement allows for adaptability; if a project transitions from a routine analysis to more complex demands, statisticians can adjust their roles accordingly. This fluidity ensures that all statistical aspects of the research remain robust and responsive to evolving needs.

Extensive Involvement

More than 20% FTE

  • Methodological Development: Leads the development and application of new or advanced methods.
  • Study Design: Develops and applies complex study designs.
  • Analysis: Performs complex statistical analyses.
  • Publications: Actively leads publications, writing most of the methods and results sections.
  • Conferences: Participates in conferences (panels, posters, talks) with potential travel required.
  • Meetings: Attends all relevant project/department meetings.

Regular Involvement

15% FTE

  • Study Design: Contributes to study design and implementation.
  • Analysis: Handles routine statistical design and analysis using standard statistical software.
  • Publications: Actively contributes to writing methods and results sections of publications.
  • Meetings: Attends all relevant project/department meetings.

Limited Involvement

10% FTE

  • Consultation: Provides consultation to the Principal Investigator (PI) on appropriate statistical methods.
  • Advisement: Primarily advises study staff on performing statistical analyses.
  • Analysis: Conducts limited statistical analyses.
  • Publications: Involved in publications by helping interpret statistical results and outlining limitations (minimal writing).
  • Meetings: Attends project/department meetings occasionally, typically to address specific issues or questions.

Very Limited Involvement

5% FTE

  • Consultation: Offers minimal consultation to the PI regarding statistical methods.
  • Advisement: Provides restricted advice to study staff on conducting analyses.
  • Analysis: Does not perform any statistical analyses.
  • Publications: Does not contribute to publications or authorship.
  • Meetings: Does not regularly attend meetings.