Senior Biostatistician - Vaccine Trials (OPV) Remote

PATH; Seattle (WA); Hybrid; USD 144,000 - 180,000; Full time

Benefits offered by this job

Generous benefits

Hybrid work model

Job summary

PATH is seeking a Senior Statistician to lead statistical activities for OPV/nOPV vaccine trials across Phases 1–3, with initial focus on oral polio vaccines. You will oversee protocol design, analysis plans, and regulatory support, coordinating with CROs and cross‑functional teams.

The role requires a Master or Doctoral degree in biostatistics, 5+ years in clinical research, proficiency in SAS and R, and ability to work in a hybrid PATH Seattle/US office environment with some travel.

Qualifications

• 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, preferably including experience presenting and discussing statistical results and study designs with external stakeholders and funders, such as the Gates Foundation.
• 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 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%.
• Ability to communicate fully in English
• Must have legal authorization to work in PATH country location, such as US, UK, Switzerland, or Belgium. Fully remote candidates in PATH country locations will be considered.

Responsibilities

• Serve as a study statistician for Phase 1, 2, and 3 clinical trials of oral polio vaccines (OPVs, nOPVs), conducting, supporting, and overseeing all statistical activities across all phases of these studies.
• Lead or contribute to the statistical design of OPV/nOPV trials, including sample size and power calculations, randomization schedules, interim/futility analyses, and Data and Safety Monitoring Board (DSMB) support.
• Develop or review statistical analysis plans and analyze and interpret data from OPV trials (e.g., immunogenicity, shedding, and safety endpoints), providing input to study reports and manuscripts with emphasis on the statistical methods section.
• Provide statistical support to CVIA's broader 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, Investigator's Brochures (IBs), Clinical Study Reports (CSRs), and other study-related documents in order to ensure collection of required data and correctness of statistical representation of data and results.
• Serve as the primary point of contact for statistical issues between the study team and statistical CRO partner, providing technical oversight of statistical CRO activities, including review of analysis specifications, statistical outputs, data review deliverables, and timelines.
• Support scientific merit reviews (SMR) of CVIA protocols to ensure high standards of rigor and scientific validity.
• 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 regulatory and prequalification submissions for clinical trials receiving PATH support (e.g., develop templates for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) statistical tables, provide specs, conducts analysis or supervises production of ISS and ISE tables).

Skills

Biostatistics knowledge

Clinical trial methodology

English communication

Education

Master or Doctoral degree in biostatistics or related field

Tools

SAS

R

Job description

PATH is seeking a Senior Statistician to lead statistical activities for OPV/nOPV vaccine trials across Phases 1–3, with initial focus on oral polio vaccines. You will oversee protocol design, analysis plans, and regulatory support, coordinating with CROs and cross‑functional teams.

The role requires a Master or Doctoral degree in biostatistics, 5+ years in clinical research, proficiency in SAS and R, and ability to work in a hybrid PATH Seattle/US office environment with some travel.