
Senior Statistician, Vaccine Innovation and Access
Posted 4 days ago

Posted 4 days ago
This is a fully remote position, open to applicants in United States, +29 more locations.
• Act as the study statistician for Phase 1, 2, and 3 clinical trials of the oral polio vaccine.
• Lead or assist in the design of statistical trials, encompassing sample size and power calculations, randomization schedules, interim/futility analyses, and support for DSMB.
• Create or evaluate statistical analysis plans and analyze as well as interpret data concerning immunogenicity, shedding, and safety endpoints.
• Contribute to clinical study reports and manuscripts, with a focus on sections detailing statistical methods.
• Support broader clinical development initiatives within CVIA and assess claims regarding efficacy and safety.
• Review or assist in the development of study protocols, Investigator’s Brochures, Clinical Study Reports, and other relevant study documents.
• Serve as the primary statistical liaison with the statistical CRO partner, overseeing their activities, outputs, deliverables, and timelines.
• Assist in the scientific merit reviews of CVIA protocols.
• Present relevant statistical information in-house.
• Represent PATH CVIA at both domestic and international scientific conferences.
• Stay updated with advancements through reading, attending seminars, and reviewing publications.
• Engage in regulatory and prequalification submissions, including statistical tables and analyses related to ISS and ISE.
• A Master’s or Doctoral degree in biostatistics, statistics, or a related scientific field, or an equivalent combination of education and experience.
• A minimum of five years of experience in supporting clinical research.
• Extensive knowledge of biostatistics and clinical trial methodologies.
• Experience with vaccine clinical trials is highly preferred.
• Familiarity with polio or enteric vaccine studies is an advantage.
• Proficient in statistical software programming languages such as SAS and R.
• Capability to support both U.S. and international trials.
• Ability to manage multiple projects simultaneously in a multidisciplinary project setting.
• Competence to work collaboratively as well as independently.
• Skill in multi-tasking and effectively prioritizing tasks and projects.
• Ability to function as a member of multidisciplinary teams.
• Proficient in conveying basic statistical concepts to both scientists and non-scientists.
• Willingness and ability to travel up to 10–15%.
• Excellent command of English communication.
• Must possess legal authorization to work in a PATH country location, such as the U.S., U.K., Switzerland, or Belgium.
• Fully remote candidates must reside in PATH country locations.
• 15 vacation days annually.
• 11 holidays each year.
• 2 personal days per year.
• 12 sick days each year.
• Comprehensive medical and dental plans.
• Life insurance coverage.
• Disability benefits.
• Retirement plan benefits.
• Hybrid workplace model unless specified otherwise.
• Option for fully remote work from a PATH country location.
• Travel commitment of up to 10–15%.
BH Partner S.A.C.
BH Partner S.A.C.
ALB Conciergerie
Pennant
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