Organization: FHI 360
Country: United States of America
Closing date: 30 Sep 2015
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: Senior Lead Biostatistician and Statistical Manager
Description:
Serve as senior lead statistician and statistical manager on a variety of clinical trials in contraception, HIV prevention, and vaccine development.
As senior lead biostatistician, serve as statistical resource to scientists; contribute to study design and implementation (e.g. sample size calculations; protocol review; and randomization plans); write statistical analysis plans (SAPs); review table/listing/figure (TLF) shells prepared by junior staff; write or review analysis data set and TLF specifications; write SAS programs for key analyses; conduct senior-level QC review of TLFs; write statistical report text; contribute to and review clinical study reports (CSRs) and manuscripts submitted for publication; conduct advanced-level statistical analyses; and actively participate on study teams.
As statistical manager, coordinate the provision of statistical services for studies and proposals. Manage BIOS-related aspects of study timelines, resource requirements, and budgets. Work with Director/Associate Directors to ensure the availability of resources to complete required tasks and to keep management informed of issues; oversee the work of junior statistical staff assisting on projects; and interact with external clients and FHI 360 clinical researchers.
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.
- Serves as Lead Statistician on research studies at all levels of complexity.
- Coordinates the provision of full statistical support for multiple research projects.
- Serves as un-blinded independent statistician for interim analyses.
- Serves as resource for other statisticians on statistical methodology, study design, therapeutic areas, and data analysis.
- Performs senior review of statistical reports, study reports, and integrated reports.
- Conducts statistical review/approval of study protocols.
- Provides significant input into the preparation and review of clinical study protocols; consults with clients on issues related to study design, statistical methodology, and sample size calculation.
- Represents research team regarding statistical issues at regulatory meetings.
- Develops and leads trainings for researchers, study clinicians or statisticians
- Continues statistical training on new methods and techniques via self- study, internal training and courses, and external conferences and courses.
Qualifications:
- Masters’ degree in relevant field, with 7-9 years’ experience in statistical analysis of clinical or biomedical studies, or PhD/DrPH degree in relevant field, with 5-7 years’ experience in statistical analysis of clinical or biomedical studies.
- Experience in clinical trials, particularly for drugs or devices submitted for regulatory approval
- Excellent communication skills (verbal and written) in English
- Demonstrated capacity to manage or coordinate the provision of statistical services
- Demonstrated leadership ability
- 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.
How to apply:
https://jobs-fhi360.icims.com/jobs/16021/senior-lead-biostatistician-and-statistical-manager/job
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