Sr. Principal Biostatistician - Clinical Trials & CRO Engagements

  • Posted on 18 February 2021
  • United States
  • Remote position
  • Closing on 20 March 2021

Job Description

Job Summary:

Oversee statistical support to the clinical trial research portfolio. Provide technical, scientific, and project management leadership. Provide statistical expertise at meetings with Contract Research Organizations (CROs) and regulatory agencies. Serve as resource to other statisticians and researchers with respect to complex analytic methodology and novel approaches to research problems. Serve as Principal Investigator. Thought leader for the organization as demonstrated by routine authorship on peer-reviewed manuscripts.

Takes leadership role in the development of high-worth or high-profile proposals. May act as spokesperson on corporate research studies and scientific projects; may advise senior management.

Accountabilities:

  • Provide scientific leadership in statistical aspects of clinical trial studies and proposals.
  • Oversee provision of statistical support for portfolios of studies.
  • Manage high volume of projects.
  • Provide senior reviews of protocols, papers, research strategies, proposals and other work done by other statisticians or project researchers.
  • Serve as consultant to CROs and sponsors regarding protocol design, sample size, analysis methods, etc. for clinical trials and other studies at all levels of complexity.
  • Provide technical, scientific, and/or project management leadership; serve as statistical resource and mentor.
  • Take leadership role in protocol development.
  • Stays current on research, statistical methodologies, and regulatory guidelines on statistical aspects via statistical training, self-study, internal training, external conferences, and courses, etc.
  • Provide expert statistical review and approvals of protocols, particularly complex, high-profile studies including those to be submitted to regulatory agencies.
  • Represent study team, division, and organization in meetings with sponsors and regulatory agencies; provide statistical expertise at high-level meetings with major funders and regulatory agencies. Responds to statistical aspects of regulatory feedback of protocols.
  • Resource to other statisticians and researchers with respect to complex analytic methodology, novel approaches to research problems, etc.
  • Thought leader for the organization as demonstrated by routine authorship on peer-reviewed manuscripts and/or presentations at conferences and meetings.
  • May serve as Principal Investigator.

Applied Knowledge & Skills:

  • Comprehensive understanding of statistical methodologies.
  • Demonstrated scientific or technical leadership
  • Scientific creativity and independent thought
  • Develops and maintains excellent interpersonal and communication skills.
  • Able to represent research team at regulatory agency meetings.
  • Looks to develop client contacts and provide new leads for business development opportunities statistically trained or statistically naïve audiences.

Problem Solving & Impact:

  • Problems are varied and complex, requiring analysis or interpretation of factors or situations.
  • Anticipates problems, proactively works to avoid them.
  • Exercises leadership within division and research teams as well as the organization and scientific community.
  • Proposes and may lead new initiatives.
  • Contributes meaningfully to short- and long-term strategic planning for division and organization as a whole

Supervision Given/Received:

  • Reports to Director.
  • Independently manages high volume workload.
  • May supervise a group of statisticians as needed.

Education:

  • Masters’ degree (or international equivalent) in statistics, biostatistics, bioinformatics or similar curriculum.
  • PhD preferred

Experience:

  • Typically requires 12+ years of research study design and analysis experience with advanced SAS programming.
  • Demonstrated expertise and leadership
  • Advance skills in multiple statistical areas.
  • Excellent interpersonal communication skills, verbal and written English.
  • Advance knowledge in statistical aspects of study design.
  • Advance experience providing statistical consultation to researchers.

Typical Physical Demands:

  • Typical office environment.
  • Ability to sit and stand for extended periods of time.
  • Ability to lift 5-50 lbs.

Technology to be Used:

  • Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand held devices.

Travel Requirements:

  • Less than 10%

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

About the Organization

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.

As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.

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