Biostatistician, Center for Vaccine Innovation and Access - Seattle, WA or Washington DC

Seattle, WA or Washington DC, United States
Competitive salary
Oct 06, 2016
Dec 01, 2016
Result Type
Position Type
Full Time

Biostatistician, Center for Vaccine Innovation and Access
Job Location: Seattle, WA or Washington DC, United States
Company Location: Seattle, WA or Washington DC, United States
Position Type: Full-Time/Regular

PATH is an international organization that drives transformative innovation to save lives and improve health, especially among women and children. We accelerate innovation across five platforms- vaccines, drugs, diagnostics, devices, and system and service innovations - that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health.

PATH’s Center for Vaccine Innovation and Access 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 15 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.

The Biostatistician sits within the Clinical Office, CVIA at PATH and reports to the Director of the Clinical Office. The Clinical Office provides leadership and support to the clinical activities conducted by various programs developing childhood vaccines, including the design of clinical development plans and protocols, implementation and analysis of clinical trials, and support for regulatory submissions leading to local registration and WHO prequalification of new vaccines.

The Biostatistician will be responsible for supporting the statistical planning and analysis needs of multiple vaccines clinical trials conducted by CVIA at PATH, spanning from the development of sound statistical strategies for vaccine testing, to participating in the assembly of US BLAs or equivalent regulatory submissions. The incumbent will provide statistical consultation on the experimental design, conduct and data analysis of clinical trials, epidemiological studies and associated laboratory research; will develop appropriate statistical approaches for expeditious testing of vaccines; and will collaborate with PATH scientists in the planning of laboratory investigations and analysis of resultant data using existing methodologies. In addition, the incumbent will provide leadership and guidance and will directly participate in the preparation of high quality Clinical Study Reports.

The Biostatistician will serve several multi-disciplinary project teams under the supervision of the Director, Clinical Office at CVIA. Work is planned and performed with CVIA’s Medical Officers and project team leaders, and is discussed with or reviewed by the Office Director. The incumbent uses sound judgment, originality, and imagination in efficiently planning the clinical research at hand and addressing unique problems. Solid communications skills will be required to liaise with partners, investigators and funders necessary to achieve overall objectives.

Performance is evaluated on the basis of overall productivity, soundness and effectiveness of research projects and responsiveness to PATH needs. This role affords an already strong biostatistician the opportunity to apply and advance their knowledge and skills in clinical research methodology through exposure to and collaboration with expert strategic consultants and partners. The incumbent's professional judgment will be monitored to ensure his/her abilities are well-aligned to assume increasingly independent initiatives and responsibilities.

Specific job duties and responsibilities include:

  • Provides advanced statistical support to the CVIA clinical development program to ensure that scientifically valid conclusions are drawn concerning claims with respect to efficacy and safety of the products under development.
  • Actively partners with multi-disciplinary project and study teams by supporting statistical activities in all phases of project-related clinical development programs.
  • Reviews study protocols, investigator’s brochures (IBs), clinical study reports (CSRs), and other study-related documents in order to ensure correctness of statistical representation of data and results, and collection of required data.
  • Is responsible for making statistic model selection, experimental design, design and analysis of clinical trials.
  • Develops or reviews statistical analysis plans, randomization schedule, sample size and power calculations for CVIA protocols.
  • Analyzes and interprets data from individual trials.
  • Provides input in preparation of study reports, including CSRs with particular emphasis on the statistical methods section, directly participating in study report preparation.
  • Participates in the preparation and review of BLAs and equivalent materials for international submissions of clinical trials receiving PATH support (e.g., develops templates for ISS and ISE statistical tables, provides specs, conducts analysis or supervises production of ISS and ISE tables).
  • Develops templates for ISS and ISE statistical tables for BLA submission in conjunction with clinical team; and provides specs, conducts analysis or supervises production of ISS and ISE tables.
  • Gives clear, well-organized in-house presentations of relevant statistical material when so requested.
  • Keeps abreast of new developments in the field by reading, attending seminars and reviewing publications.
  • Collaborates in the writing of scientific papers reporting clinical studies.
  • Creates and maintains effective liaison with numerous other scientists and researchers at universities, research centers, governmental and non-governmental organizations.

Other responsibilities include:

  • Provides technical oversight of PATH contracts supporting data management.
  • Actively participates in the assembly, or reviews data, for Safety Monitoring Committees and Data and Safety Monitoring Board meetings.
  • Consults with professionals within and outside PATH, the FDA, WHO and other organizations, and with partners and contractors to ensure accurate biostatistical strategies are applied to trials.

Required Experience

  • Master’s or Doctoral degree in scientific discipline (statistics, mathematical statistics, biostatistics) required.
  • Proven experience applying advanced knowledge of biostatistics and clinical trial methodology in support of clinical research in an industry or academic setting required.
  • Excellent knowledge of various phases of drug/vaccine development processes in the US as well as internationally; and experience supporting NDS/BLA submissions strongly preferred.
  • Well-versed in the review study protocols, CRFs, and other study-related documents in order to ensure correctness of statistical representation of data and results, and collection of required data.
  • Strong knowledge of statistical software programming with SAS; and familiarity with Oracle database structures and complex queries.
  • Ability to work on multiple projects simultaneously, effectively prioritizing work and projects and communicating realistic expectations on timeline and deliverables.
  • Ability to remain flexible and work collaboratively and independently in a multidisciplinary project environment.
  • Strong oral and written communication skills, with the ability to clearly communicate (and present) basic statistical concepts to other scientists and nonscientists.
  • Must have legal authorization to work in the United States.

To apply, please click on the ‘Apply’ button

PATH is dedicated to diversity and is an equal opportunity employer. 

PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, gender identity or orientation, 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.