Senior Biostatistician
Company: Ortho Clinical Diagnostics
Location: San Diego
Posted on: March 19, 2023
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Job Description:
QuidelOrtho unites the strengths of Quidel Corporation and Ortho
Clinical Diagnostics, creating a world-leading in vitro diagnostics
company with award-winning expertise in immunoassay and molecular
testing, clinical chemistry and transfusion medicine. We are more
than 6,000 strong and do business in over 130 countries, providing
answers with fast, accurate and consistent testing where and when
they are needed most - home to hospital, lab to clinic.Our culture
puts our team members first and prioritizes actions that support
happiness, inspiration and engagement. We strive to build
meaningful connections with each other as we believe that employee
happiness and business success are linked. Join us in our mission
to transform the power of diagnostics into a healthier future for
all.The RoleAs we continue to grow as QuidelOrtho, we are seeking a
Sr. Biostatistician to works with Biostatistics team members to
provide statistical support under minimal supervision of the
Biostatistics leadership. The Senior Biostatistician performs data
analyses and prepares presentations and publications. Assists
quality control with provision of advanced statistical methods,
supports and refines product complaint analyses, and manufacturing
efficiencies.This individual will work onsite in San Diego, CA,
Rochester, NY, or Raritan, NJ.The ResponsibilitiesPerforms
statistical analysis in accordance with protocol and contributes in
the report from statistical perspective.Performs quality control of
statistical analysis and audit data.Provides biostatistical support
to product development (IVD assays, instruments and software) and
product evaluation (design verification and design
validation).Develops, optimizes, verifies and validates data
reduction and checks algorithms for instrument and software
products.Increases productivity in product development and
regulatory clearance.Provides consultation and guidance on
statistical issues with other members of R&D,
Clinical/Regulatory, QA/QC and Operations.Conducts data review,
writes reports, and presents analyses and interpretations to other
members of the R&D group.Practices statistical experimental
design (DOE), data analysis and interpretation.Creates sample size
determinations, calculations of clinical accuracy, PPV, NPV, and
other statistics of value for clinical trials and regulatory
submissions.Organizes in design of analytical/clinical
studies.Prepares tables, listing and figures for the protocol and
report.Perform other work-related duties as assigned.The
IndividualRequired:BS in BiostatisticsMinimum of 5 years of
relevant industrial experienceFamiliarity with R applications and
DoE software packagesExpert knowledge in experimental design
(DoE)Expertise in standard statistical techniques (e.g.
experimental designs, statistical modeling, exploratory data
analysis, sample size determination, statistical
simulation).Knowledge in mathematical statistics, nonparametric
statistics, applied probability, multivariate analysis, nonlinear
regression, generalized linear models, categorical data analysis,
and statistical quality control.Demonstrates ability to collaborate
effectively and work in a matrix organization.Service orientation
towards internal customersHigh degree of self-motivation and
commitmentStrong communication skills, written and verbalKnowledge
of related quality system regulations and processes.Preferred:The
Key Working RelationshipsInternal Partners:Interacts
cross-functionally (R&D, Clinical/Regulatory, Quality,
Engineering and Manufacturing) and companywide, on a continual
basis presenting statistical expertise on product development
projects. -The Work EnvironmentTypical office environment. However
remote work may be part of this employment.Up to 100% of time at
desk, standing or sitting extended periods of time.Flexible work
hours to meet project deadlinesSalary TransparencyThe salary range
for this position takes into account a wide range of factors
including education, experience, knowledge, skills, geography, and
abilities of the candidate, in addition to internal equity and
alignment with market data. At QuidelOrtho, it is not typical for
an individual to be hired at or near the top range for their role
and compensation decisions are dependent on the facts and
circumstances of each case. The salary range for this position is
$107,100 to $197,000 and is bonus eligible or eligible for
incentive compensation. QuidelOrtho offers a comprehensive benefits
package including medical, dental, vision, life, and disability
insurance, along with a 401(k) plan, employee assistance program,
Employee Stock Purchase Plan, paid time off (including sick time),
and paid Holidays. All benefits are non-contractual, and
QuidelOrtho may amend, terminate, or enhance the benefits provided,
as it deems appropriate.QuidelOrtho believes in Equal Opportunity
for all and is committed to ensuring all individuals, including
individuals with disabilities, have an opportunity to apply for
those positions that they are interested in and qualify for without
regard to race, religion, color, national origin, citizenship, sex,
sexual orientation, gender identity, age, veteran status,
disability, genetic information, or any other protected
characteristic. QuidelOrtho is also committed to providing
reasonable accommodations to qualified individuals so that an
individual can perform their duties. If you are interested in
applying for an employment opportunity and require special
assistance or an accommodation to apply due to a disability, please
contact us at orthorecruiting@orthoclinicaldiagnostics.com
QuidelOrtho unites the strengths of Quidel Corporation and Ortho
Clinical Diagnostics, creating a world-leading in vitro diagnostics
company with award-winning expertise in immunoassay and molecular
testing, clinical chemistry and transfusion medicine. We are more
than 6,000 strong and do business in over 130 countries, providing
answers with fast, accurate and consistent testing where and when
they are needed most - home to hospital, lab to clinic.Our culture
puts our team members first and prioritizes actions that support
happiness, inspiration and engagement. We strive to build
meaningful connections with each other as we believe that employee
happiness and business success are linked. Join us in our mission
to transform the power of diagnostics into a healthier future for
all.Important: Don't see a current job opportunity that is just
right for you? -Take 2 minutes and create a custom -job alert
-which will notify you when we post a position which matches your
interests. It is quick and easy and will make your career search
easier.or Visit the QuidelOrtho to learn about our solutions,
products, and services. QuidelOrtho believes in Equal Opportunity
for all and is committed to ensuring all individuals, including
individuals with disabilities, have an opportunity to apply for
those positions that they are interested in and qualify for without
regard to race, religion, color, national origin, citizenship, sex,
sexual orientation, gender identity, age, veteran status,
disability, genetic information, or any other protected
characteristic. QuidelOrtho is also committed to providing
reasonable accommodations to qualified individuals so that an
individual can perform their job related duties. If you are
interested in applying for an employment opportunity and require
special assistance or an accommodation to apply due to a
disability, please contact us at
orthorecruiting@orthoclinicaldiagnostics.com.
Keywords: Ortho Clinical Diagnostics, San Diego , Senior Biostatistician, Other , San Diego, California
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