Director, Statistics and Data Management, Center for Vaccine Innovation and Access

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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 heath 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.

Statisticians in the clinical team provide support to the various CVIA programs, including the design of protocols, development of statistical analysis plan, analysis of trial data, and drafting or reviewing clinical study reports and manuscripts for publication. The incumbent will also provide statistical consultation on the experimental design and data analysis of clinical trials and epidemiological studies.

The Director of Statistics and Data Management provides leadership to and oversight of the biostatistics and data management teams, as described below.

Responsibilities

• Provide management and oversight of a small group of highly skilled clinical trial statisticians and senior-level data management personnel.
• Partner with data management personnel to organize and prioritize statistical and data management support across project teams and to ensure robust data collection and cleaning activities are available to clinical study teams.
• Provide technical leadership to the CVIA statistics and data management team on activities associated with clinical development of vaccines.
• Provide statistical leadership to new proposal development.
• Create and maintain effective partnerships with numerous other scientists and researchers at universities, research centers, governmental and non-governmental organizations.
• Serve as a key liaison to funders on aspects of clinical trial design and data interpretation.
• Define and ensure progression of functional area objectives.
• Play an active role in multi-disciplinary project and study teams by conducting, supporting, and overseeing all statistical activities in all phases of project related clinical development programs.
• Provide statistical support to CVIA's 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 review study protocols, IBs, CSRs and other study-related documents in order to ensure collection of required data and correctness of statistical representation of data and results.
• Develop or review statistical analysis plans, randomization schedule, sample size and power calculations for CVIA protocols, and data collection instruments, as necessary.
• Analyze and interpret data from individual trials and provide input in preparation of study reports and manuscripts, with emphasis on the statistical methods section.
• Provide statistical expertise in the review and selection process for data management/ statistical CROs. Once DM/Stat CRO is selected, the incumbent will provide technical oversight of their activities.
• Provide leadership to development and maintenance of Quality documents associated with CVIA Clinical activities, including SOPs, audit agendas and reports, and similar documents.
• 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 BLAs and equivalent materials for international submissions of clinical trials receiving PATH support (e.g., develop templates for ISS and ISE statistical tables, provide specs, conduct analysis or supervise production of ISS and ISE tables).

Required Skills and Experience

• Doctorate degree in scientific discipline (statistics, mathematical statistics, biostatistics) plus five or more years of experience in supporting a breadth of clinical vaccine research or Masters degree in a scientific discipline with fifteen or more years of experience in supporting a breadth of clinical vaccine research.
• Experience supporting clinical trials in the US and internationally.
• Advanced knowledge of biostatistics and clinical trial methodology.
• Strong knowledge of statistical software programming with SAS and/or R.
• Ability to work on multiple projects simultaneously and also have the flexibility of working both collaboratively and independently in a multidisciplinary project environment.
• Demonstrated ability to manage multiple projects simultaneously, effectively prioritize tasks, and ensure timely completion in a fast-paced environment.
• Ability to work as a member of multidisciplinary teams, demonstrating strong collaboration skills and the ability to integrate perspectives from various disciplines.
• Proven skill in conveying statistical concepts to a wide range of audiences, including scientists and non-scientists, in a clear and accessible manner.
• Ability and willingness to travel up to 10-15%.
• For remote candidates: ability to work primarily remotely.
• Must have legal authorization to work in the United States, United Kingdom, Switzerland, or Belgium. Fully remote candidates in these 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 $212,000-$265,000. 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; disability and retirement benefits. For more details click here.

Hybrid Work

PATH operates within a hybrid workplace model unless otherwise noted. Hybrid employees must reside within commuting distance to one of our PATH offices. PATH's US offices are located in Seattle, WA and Washington, DC.

Please note this position will consider US locations other than noted in the job posting and can be fully remote in the US.

PATH is dedicated to building an inclusive workforce where diversity is valued.

PATH is an equal opportunity employer. Every qualified applicant will be considered for employment.

PATH does not discriminate based on race, color, religion, caste, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.