Senior Biostatistician (REMOTE)
Company: Guardant Health
Location: Greenville
Posted on: May 14, 2022
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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
Qualifications
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. An employee 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
our Privacy Notice for Job Applicants .
Please visit our career page at:
http://www.guardanthealth.com/jobs/
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Keywords: Guardant Health, Greenville , Senior Biostatistician (REMOTE), Other , Greenville, South Carolina
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