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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates advanced knowledge of biostatistics and clinical trial methodology, with a strong focus on vaccine clinical trials. Proficient in statistical software programming using SAS and R, and capable of effectively communicating statistical concepts to diverse audiences.
Highest-signal resume keywords
Biostatistics ExpertiseClinical Trial MethodologySAS ProgrammingR ProgrammingVaccine Clinical Trials Experience
ATS Keywords
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Hard Skills
Statistical AnalysisSample Size CalculationsPower CalculationsRandomization SchedulesInterim AnalysesStatistical Analysis PlansData InterpretationStatistical Software ProgrammingClinical Study ReportsRegulatory Submissions
Soft Skills
CollaborationCommunicationMulti-taskingPrioritizationIndependent Work
Industry Keywords
Clinical ResearchOral Polio VaccineImmunogenicitySafety EndpointsDSMB SupportCRO ManagementScientific MeetingsInternational TrialsInvestigator’s BrochuresPhase 1 2 3 Trials
About the role
Key responsibilities & impact- Serve as study statistician for Phase 1, 2, and 3 oral polio vaccine clinical trials
- Lead or contribute to statistical trial design, including sample size and power calculations, randomization schedules, interim/futility analyses, and DSMB support
- Develop or review statistical analysis plans and analyze and interpret immunogenicity, shedding, and safety endpoint data
- Provide input to clinical study reports and manuscripts, especially statistical methods sections
- Support broader CVIA clinical development programs and evaluate efficacy and safety claims
- Contribute to or review study protocols, Investigator’s Brochures, Clinical Study Reports, and other study documents
- Serve as primary statistical contact with the statistical CRO partner and oversee CRO activities, outputs, deliverables, and timelines
- Support scientific merit reviews of CVIA protocols
- Present relevant statistical material in-house
- Represent PATH CVIA at domestic and international scientific meetings
- Keep current with developments through reading, seminars, and publications
- Participate in regulatory and prequalification submissions, including ISS and ISE statistical tables and analyses
Requirements
What you’ll need- Master or Doctoral degree in biostatistics, statistics, or a related scientific discipline, or an equivalent combination of education and experience
- Five or more years of experience supporting clinical research
- Advanced knowledge of biostatistics and clinical trial methodology
- Experience supporting vaccine clinical trials strongly preferred
- Experience with polio or enteric vaccine studies a plus
- Strong knowledge of statistical software programming with languages such as SAS and R
- Ability to support US as well as international trials
- Ability to work on multiple projects simultaneously in a multidisciplinary project environment
- Ability to work collaboratively and independently
- 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 scientists and nonscientists
- Ability and willingness to travel up to 10–15%
- Ability to communicate fully in English
- Must have legal authorization to work in a PATH country location, such as US, UK, Switzerland, or Belgium
- Fully remote candidates must be in PATH country locations
Benefits
Comp & perks- 15 vacation days per year
- 11 holidays per year
- 2 personal days per year
- 12 sick days per year
- Medical and dental plans
- Life insurance
- Disability benefits
- Retirement benefits
- Hybrid workplace model unless otherwise noted
- Fully remote work option from a PATH country location
- Travel up to 10–15%
