Senior Statistician, Center for Vaccine Innovation and Access

PATH; Tennessee; Hybrid; USD 144.000 - 180.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Comprehensive benefits

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Biostatistics

Clinical trial design

Data analysis

Statistical concepts communication

Ausbildung

Master's or Doctoral degree in biostatistics or related field

Tools

SAS

R

Jobbeschreibung

Senior Statistician

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 health 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.

PATH is seeking a Senior Statistician who is an experienced clinical trial biostatistician to support the design, planning, execution, and analysis of Phase 1, 2, and 3 vaccine clinical trials, with an initial focus on oral polio vaccine studies. Within CVIA, the polio program supports the global polio eradication effort through a broad portfolio of clinical, epidemiological, and diagnostic work, including clinical development of novel oral polio vaccines (nOPVs), with projects spanning early-phase safety and immunogenicity studies through large Phase 3 international clinical trials. The Senior Statistician's initial focus will be on the clinical development of nOPVs, including two Phase 3 trials currently in design stage, with opportunities to contribute to other CVIA vaccine development programs as needed.

Reporting to the Director of Statistics and Data Management, under the leadership of the Global Head of Clinical, statisticians on the clinical team support CVIA programs by overseeing CROs; contributing to protocol design; developing statistical analysis plans; analyzing trial data; drafting and reviewing clinical study reports and manuscripts; and providing statistical consultation on the design and analysis of clinical trials and epidemiological studies.

This role requires both hands‑on statistical leadership and effective oversight of external partners, with responsibilities spanning protocol design, analysis planning, clinical study reporting, regulatory support, and scientific communication.

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).

Required skills and experience

• 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.

PATH is a diverse nonprofit organization that creates a culture of collaboration and partnership. Learn more about the impact you can make globally here.

We offer our employees a competitive salary and generous benefits. For candidates based in the U.S., the annual salary range for this position is $144,000-$180,000. The final salary is based on a variety of objective factors. PATH provides a comprehensive benefit package that includes 15 vacation, 11 holiday, 2 personal, and 12 sick days per year; medical and dental plans; life insurance; and disability and retirement benefits. For more details click here.

Remote & Hybrid Work

PATH operates within a hybrid workplace model unless otherwise noted. Hybrid employees must reside within commuting distance of one of our PATH offices. PATH's US offices are located in Seattle, WA, and Washington, DC. This position is approved to be a remote employee from a US state where PATH is registered.