Senior Biostatistician, Precision Oncology - REMOTE
Company: Penfield Search Partners Ltd
Location: San Jose
Posted on: May 15, 2022
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Job Description:
Our client is a leading precision oncology company focused on
helping conquer cancer globally through use of its proprietary
blood tests, vast data sets and advanced analytics. Their
proprietary platform leverages capabilities to drive commercial
adoption, improve patient clinical outcomes and lower healthcare
costs across all stages of the cancer care continuum and aims to
address the needs of early-stage cancer patients with early
detection. In this role you will 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. This is a real
opportunity to gain experience in pivotal cancer screening clinical
trials, gain familiarity with the diagnostic environment and to
co-operate with team members in major clinical trials and smaller
scale real world evidence projects.
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 a 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
MS-level candidates will be considered as well. - 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
Keywords: Penfield Search Partners Ltd, San Jose , Senior Biostatistician, Precision Oncology - REMOTE, Healthcare , San Jose, California
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