Senior Biostatistician - Global Vaccine Trials (Remote)

PATH; Tennessee; Hybrid; USD 144,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Comprehensive benefits

Job summary

PATH is seeking a Senior Statistician to lead statistical design, analysis, and oversight for Phase 1–3 oral polio vaccine trials within CVIA. The role involves collaboration with CROs, protocol development, and contributing to regulatory submissions.

You will work with a multidisciplinary team to ensure rigorous statistical practices, support international studies, and communicate complex statistics clearly to scientists and sponsors.

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 with external stakeholders and funders.
• Advanced knowledge of biostatistics and clinical trial methodology.
• Experience supporting vaccine clinical trials preferred; polio or enteric vaccines a plus.
• Strong knowledge of statistical software programming with SAS and R.
• Ability to work on US and international trials.

Responsibilities

• Serve as a study statistician for Phase 1–3 OPV/nOPV trials and oversee statistical activities across all phases.
• Lead or contribute to statistical design, including sample size, power calculations, randomization, interim analyses, and DSMB support.
• Develop or review SAPs and analyze data for trial reports and manuscripts, focusing on statistical methods.
• Provide statistical support to CVIA's broader clinical development programs to ensure rigorous conclusions on efficacy and safety.
• Contribute to and review study protocols, IBs, CSRs, and other documents to ensure proper data collection and statistical representation.
• Serve as primary statistical contact with CRO partners, overseeing outputs, analyses, and timelines.
• Support SMR of CVIA protocols to ensure rigor and validity.
• Give clear, organized in-house presentations of statistical material.
• Attend and represent PATH CVIA at scientific meetings.
• Keep up with new developments by reading and attending seminars.
• Assist in regulatory submissions and creation of ISS/ISE tables as needed.

Skills

Biostatistics

Clinical trial design

Data analysis

Statistical concepts communication

Education

Master's or Doctoral degree in biostatistics or related field

Tools

SAS

R

Job description

PATH is seeking a Senior Statistician to lead statistical design, analysis, and oversight for Phase 1–3 oral polio vaccine trials within CVIA. The role involves collaboration with CROs, protocol development, and contributing to regulatory submissions.

You will work with a multidisciplinary team to ensure rigorous statistical practices, support international studies, and communicate complex statistics clearly to scientists and sponsors.