Durham (United States of America) | Washington D.C.
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 and technology — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 70 countries and all U.S. states and territories. We are currently seeking qualified candidates for the position of: Lead Biostatistician
This role will serve as lead biostatistician on a variety of clinical trials in contraception, HIV prevention, and vaccine development.
The Lead Biostatistician will write statistical analysis plans (SAPs); design table/listing/figure (TLF) shells or review shells produced by others. Write analysis data set and TLF specifications; write SAS programs for key analysis datasets and analyses. Ensure the accuracy of TLFs; write statistical report text. Contribute to and review clinical study reports (CSRs) and manuscripts submitted for publication; and actively participate on study teams. Serve as statistical resource to scientists; contribute to study design and implementation (e.g. sample size calculations; protocol review; and randomization plans).
Job Summary / Responsibilities:
- Serves as a functional lead role or assists functional lead in the design, analysis, and reporting of clinical and other biomedical studies.
- Writes statistical analysis plans, performs statistical analyses, contributes to and reviews study reports, and interacts with other study team members and clients on study set up (including randomization) and conduct, including timelines and financial oversight.
- Performs a leadership role in managing statistical project support or providing intermediate to advanced statistical support.
- Serve as statistical project manager, statistical consultant, and lead statistical analyst for a variety of research projects.
- Depending on experience, serves as lead statistician on study team for studies of non-complex nature or in supportive role to lead biostatistician on studies of complex nature.
- Provide statistical input on case reports forms and study operation manual; prepare data checking specifications.
- Write data analysis plans for review/approval by senior biostatisticians.
- Draft table, listing, and figure shells for review by study clinicians and researchers.
- Advise project leader regarding the randomization plan. Prepare randomization.
- Develop specifications for analysis data sets and data tables, listings, figures.
- Write statistical analysis programs using SAS or other statistical software to create or verify analysis data sets and data tables, listings, and figures per specifications.
- Carries out basic or intermediate- level statistical analysis; assess analysis assumptions.
- Draft statistical report text for senior biostatistician review.
- Maintain appropriate documentation.
- Help draft statistical sections of study reports. Review study reports and manuscripts for accuracy.
- Determine resource projections and project schedules.
- Perform billable work in accordance with policies and standard operating procedures.
- Perform other duties as assigned.
- Serve as consultant to researchers regarding study design, sample size, analysis methods, etc. for clinical trials and other studies of simple to moderate complexity.
- Provide statistical reviews of protocols, papers and reports.
- Contribute to the development and maintenance of systems assuring the timely provision of high quality statistical services.
- Masters’ degree in relevant field, with 5-7 years’ experience in statistical analysis of clinical or biomedical studies, or PhD/DrPH degree in relevant field, with 2-3 years’ experience in statistical analysis of clinical or biomedical studies.
- Experience in clinical trials, particularly for drugs or devices submitted for regulatory approval
- Demonstrated skills in multiple statistical areas
- Excellent communication skills (verbal and written) in English
- Solid understanding of statistical aspects as well as scientific and ethical principles in biomedical research study design and implementation
- Ability to interact successfully with external clients and FHI 360 research staff at all levels
- Independently manage high volume work load
- Experience with clinical studies conducted in developing countries or other resource-constrained settings is a plus.
This job description 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.
We offer competitive compensation and an outstanding benefit package. Please click here to visit FHI 360's Career Center for a list of all open positions.
FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is committed to providing equal employment opportunity without regard to race, color, religion, sex, gender identity, sexual orientation, national or ethnic origin, age, disability or status as a veteran with respect to policies, programs, or activities.
- Organization: FHI 360 - Family Health International
- Location: Durham (United States of America) | Washington D.C.
- Grade: Mid/Senior - Internationally recruited position - Mid/Senior level
- Public Health and Health Service
- Closing Date: 2016-01-08