Job DescriptionJob Summary:
Oversee the clinical and non-clinical research conducted by FHI 360 staff and other partners globally – including study design, data analysis and interpretation of results. The department provides a wide range of services for quantitative research including study design, data management, consultation, training, data analysis, documentation, regulatory compliance, and reporting and dissemination. Possess expertise in biostatistics and in-dept knowledge of data management principles and research regulatory requirements. The director will serve as a division manager and a statistical resource or data manager. High level expertise in various statistical areas of work applicable to the research portfolios supported by the division is required. Experience with CDISC standards for eCTD submissions preferred.
Applied Knowledge & Skills:
- Develops and implements a strategic plan for the division that aligns with the vision and goals of the department.
- Aligns business development opportunities with the strategic plan, including serving as proposal design lead, technical writer and/or review, as necessary.
- Determines staffing needs of the division and systems for biostatistical research and data management operations.
- Works with directors of other groups to assure that biostatistics and data management services meet the organization’s research staff’s needs.
- Coordinates, manages and evaluates the activities of staff, including identification of training and professional development needs.
- Reviews scientific proposals, study protocols, papers and final study reports to assure the appropriate use of statistical and data management procedures and interpretation.
- Influences proper use of statistics and adherence to data management standards across a comprehensive research portfolio.
- Works with the internal statisticians and programmers to ensure the quality of deliverables and on quality assurance (QA) of data outputs.
- Oversees the work of the biostatistics staff in the design and implementation of analysis plans for research studies to assure that sound analytical procedures are efficiently applied.
- Oversees the work of the data project managers and data systems programmers in the design and implementation of data management plans for research studies to assure the integrity of study data.
- Serves as a resource to staff and contributors on methodological and statistical problems encountered in study design, data analysis and synthesis/presentation of results.
- Serves as the representative to Food and Drug Administration (FDA), other regulatory agencies, USAID staff and collaborating organizations and makes presentations on behalf of the organization as appropriate.
- Serves as technical monitor for subawards related to biostatistical and data management services.
- Identifies the need for, helps write, and reviews Standard Operating Procedures to assure quality of research.
- Represents the department on committees, task forces, and audits.
- Carries out advanced level statistical analyses or database development. This may include serving as lead biostatistician or lead data manager for select studies or trials.
- May write statistical sections of study reports; review reports and manuscripts for accuracy of reporting and inference.
- Stays current on relevant research and statistical methodologies and database development via statistical or database training, self-study, internal training and courses, external conferences and courses, for example.
- Performs other duties as assigned.
Problem Solving & Impact:
- Advance skills in multiple statistical areas or database development.
- Ability to function independently as lead statistician or lead database manager.
- Understanding of scientific and ethical principles and industry best practices in biomedical and other non-clinical research analysis.
- High level depth of statistical knowledge, such as: working knowledge of more complex methods, wider range of therapeutic areas; or analysis methods for a broader range of study designs.
- Ability to communicate and interact effectively with non-statistical colleagues on project teams.
- Knowledge of global public health research.
- Excellent interpersonal communications skills (verbal & written) in English.
- Ability to work in multidisciplinary teams, understand viewpoints of others, and convey biostatistical information to educate and recommend options in layman’s terms.
- Problems are varied and complex, requiring analysis or interpretation of factors or situations. Anticipates problems, proactively works to avoid them. Proposes and may lead new initiatives.
- Reports to Department Director
- Independently manages high volume work load.
- Supervises senior staff (e.g., associate director, managers, and others).
- Masters’ Degree in relevant field with 10+ years’ experience
- Doctorate Degree (with 5+ years of experience) preferred.
Typical Physical Demands:
- Typically requires 10+ years of experience (including 8+ years of leadership and line management skills) in clinical trials data management gained in a CRO, Pharmaceutical, Health services, Non-profit NGO or Biotechnology company.
- Demonstrated expertise and leadership in statistical analysis of a variety of research projects with demonstrated expertise or high-level understanding of clinical or other biomedical studies of drugs, biologics, and/or devices submitted to stringent regulatory authorities.
- Experience with data management principles and regulatory requirements.
Technology to be Used:
- Typical office environment.
- Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
- Ability to sit and stand for extended periods of time.
- Ability to lift 5 - 25 lbs.
- Personal Computer, Microsoft Office 365 (i.e. Word, Excel, PowerPoint, Skype/TEAMS, e-mail), office telephone, cell phone and printer/copier.
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.
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 and Technology– creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries, all 50 U.S. states and all U.S. territories.