NCBiotech Jobs Board ● Connecting North Carolina's life science employers and workforce.

Job: Senior Principal Biostatistician -Clinical Trials and CRO Engagements, FHI 360, 27701, NC

Employer banner ad -

General Information


Job title:
Senior Principal Biostatistician -Clinical Trials and CRO Engagements
Job location:
27701, NC  99999 United States
Requisition code:
RQ2021200243
Date posted:
04/06/2021
Compensation:
Job category:
Clinical Research
Employment type:
Full time

Job Description


Job Description Summary

Oversee statistical support to one or more research portfolios. Provide statistical expertise at meetings with funders and regulatory agencies. Serves as a resource to other statisticians and researchers with respect to complex analytic 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. Serves as a 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.

Job Description

Oversee statistical support to one or more research portfolios. Provide statistical expertise at meetings with funders and regulatory agencies. Serves as a 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 and/or presentations at conferences and meetings. Takes a leadership role in the development of high-worth or high-profile proposals. Make substantial contributions to scientific literature and the advancement of statistical analysis or research methodology. May act as spokesperson on corporate research studies and scientific projects; may advise senior management.

Accountabilities:

Provide scientific leadership in statistical aspects of research studies and proposals
Oversee provision of statistical support for portfolios of studies.
Provide senior reviews of protocols, papers, research strategies, proposals and other work done by other statisticians or project researchers.
Serve as consultant to researchers regarding study 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.
Plan and execute training/training materials for internal and external statisticians and researchers.
Takes a leadership role in proposal development.
Stays current on research and statistical methodologies via statistical training, self-study, internal training and courses, 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.
Represents 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.
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.
Takes a leadership role in the development of high-worth or high-profile proposals.
Recognized leader in field of expertise as evidenced by serving on scientific or technical advisory boards; speaking, organizing, or leading conferences; teaching university-level courses; participating in national or international technical guidance or standards-setting, etc.
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 the 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.

Job Requirements


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 the research team at regulatory agency meetings.
Looks to develop client contacts and provide new leads for business development opportunities to 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.
Ph.D. 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%

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
(Job number: 4035884)
Do you know someone who would be interested in this job?   Tell them about it.