Senior Statistician, Center for Vaccine Innovation and Access
il y a 1 semaine
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PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world's most pressing heath challenges.
PATH's Center for Vaccine Innovation and Access (CVIA) brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world. CVIA's current portfolio encompasses more than two dozen vaccines either in development or already in use to protect against fifteen different diseases. Our focus is on vaccines to address the leading diseases that claim children's lives worldwide: pneumonia, diarrheal disease, and malaria; as well as other global health priorities, such as polio and meningitis. We work in partnership with national health ministries, pharmaceutical manufacturers, donors, international financing and regulatory organizations, and many others. PATH has led numerous global partnerships, including the award-winning Meningitis Vaccine Project and the Malaria Vaccine Initiative, which helped develop the first malaria vaccine candidate recommended for pilot implementation.
The Senior Statistician on the clinical team will provide support to the various CVIA programs, including the design of protocols, development of statistical analysis plan, analysis of trial data, and drafting or reviewing clinical study reports and manuscripts for publication. Additionally, the Senior Statistician will provide statistical consultation on the experimental design and data analysis of clinical trials and epidemiological studies.
Responsibilities
Reporting to the Director of Statistics in CVIA Clinical, the Senior Statistician will:
Play an active role in multi-disciplinary project and study teams by conducting, supporting, and overseeing all statistical activities in all phases of project-related clinical development programs. Provide statistical support to CVIA's clinical development programs to ensure that scientifically valid conclusions are drawn concerning claims with respect to efficacy and safety of the products under development. Contribute to and/or review study protocols, IBs, CSRs and other study-related documents in order to ensure collection of required data and correctness of statistical representation of data and results. Develop or review statistical analysis plans, randomization schedule, sample size and power calculations for CVIA protocols. Analyze and interpret data from individual trials and provide input in preparation of study reports and manuscripts, with emphasis on the statistical methods section. Provide statistical expertise in the review and selection process for data management or statistical CROs. Once DM/Stat CRO is selected, the incumbent will provide technical oversight of their activities. Support ORA scientific merit reviews (SMR) of protocols ensuring high standards and rigor. Give clear, well-organized, in-house presentations of relevant statistical material when requested. Attend and represent PATH CVIA at key domestic and international scientific meetings. Keep abreast of new developments in the field by reading, attending seminars, and reviewing publications. Participate in the preparation and review of BLAs and equivalent materials for international submissions of clinical trials receiving PATH support (e.g., develop templates for ISS and ISE statistical tables, provide specs, conduct analysis or supervise production of ISS and ISE tables). Create and maintain effective liaison with numerous other scientists and researchers at universities, research centers, governmental and non-governmental organizations.Required Skills and Experience
Master or Doctorate degree in a scientific discipline (statistics, mathematical statistics, biostatistics, or related field) plus a minimum of 5-10 years of experience required in supporting clinical research, including industry experience in various phases of clinical research and supporting US and international trials. Advanced knowledge of biostatistics and clinical trial methodology. Strong knowledge of statistical software programming with languages such as SAS and R. Ability to work on multiple projects simultaneously and also have the flexibility of working both collaboratively and independently in a multidisciplinary project environment. Ability to multi-task and effectively prioritize work and projects. Ability to work as a member of multidisciplinary teams. Ability to clearly communicate basic statistical concepts to other scientists and nonscientists. Ability and willingness to travel up to 10-15%. Must have legal authorization to work in the US, UK, Switzerland, or Belgium. Fully remote candidates in these locations will be considered.-
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