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Senior Biostatistician (Remote, US)

Company: Guardant Health
Location: Raleigh
Posted on: June 24, 2022

Job Description:

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360 -, Guardant360 CDx, Guardant360 TissueNext---, Guardant360 Response---, and GuardantOMNI - tests for advanced stage cancer patients, and Guardant Reveal--- for early-stage cancer patients. These tests fuel development of its screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.

Job Description

Be part of a team in the late scientific stages of making breakthrough medical diagnostics available for patients. You will support the adoption of new cancer screening technologies by designing studies to validate their performance leading to regulatory approvals.

  • You will be responsible for the following statistical activities that support clinical trials:
    • Overseeing study design
    • Authoring statistical sections of the study protocol/clinical study report
    • Drafting associated analyses into the Statistical Analysis Plan (SAP)
    • Reviewing/interpreting results of the data generated from the study
    • You will be the subject matter expert in biostatistics, data analysis and study design for the full team that includes Clinical Operations, Regulatory Affairs, QA, Software Engineering, external partners, and regulatory agencies.

      Essential Duties and Responsibilities:
      • Provide statistical input to study design, protocol development, sample size calculation, care report form, interpretation of study results, clinical study report and on addressing questions from regulatory agencies
      • Develop and maintain Statistical Analysis Plans (SAPs) that include derived variables and templates of tables, listings and figures
      • Collaborate with statistical programmers, biostatisticians, clinical operations, data managers, regulatory affairs and project management to meet project timelines and deliverables
      • Work to develop presentations for internal/external stakeholders
      • Support a variety of statistical programming activities

        • Ph.D. in biostatistics and 3+ years of relevant experience with experimental design and associated statistical analyses (e.g. hypothesis testing, regression and method comparison)
        • Strong problem-solving skills and able to identify issues and investigate causes independently to formulate solutions
        • Familiarity with method comparison analyses such as Deming regression and the variety of non-parametric methods
        • Familiarity with time-to-event data and the corresponding statistical methods (ie. Kaplan-Meier method, Cox proportional hazards regression, etc)
        • Experience with SAS statistical programming
        • Experience with or capability to learn R
        • Able to work independently and in a collaborative environment
        • Able to communicate effectively with cross-functional teams and to work in both small and large working teams
        • Ability to multi-task and interface with team members who are working under deadlines; ability to set priorities and excellent time management skills
        • Have the curiosity in improving statistical methods and practices in support of cancer screening

          What you will gain:
          • Experience in pivotal cancer screening clinical trials and gain familiarity with the diagnostic environment
          • Be part of a team culture that is inspired by our values
          • Get opportunity to co-operate with team members in major clinical trials and smaller scale real world evidence projects

            Additional Information

            Covid Vaccination Policy:Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant's COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws.Anemployee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters.

            Employee may be required to lift routine office supplies and use office equipment.Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment.Ability to sit for extended periods of time.

            Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

            All your information will be kept confidential according to EEO guidelines.

            To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review ourPrivacy Notice for Job Applicants.

            Please visit our career page at:http://www.guardanthealth.com/jobs/

Keywords: Guardant Health, Raleigh , Senior Biostatistician (Remote, US), Other , Raleigh, North Carolina

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