Posted on: November 20, 2023
The Opportunity 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 Role As 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 Responsibilities
- Performs statistical analysis in accordance with protocol and
contributes in the report from statistical perspective.
- Performs quality control of statistical analysis and audit
- 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
- Provides consultation and guidance on statistical issues with
other members of R&D, Clinical/Regulatory, QA/QC and
- 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
- 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
- Designs databases.
- Perform other work-related duties as assigned. The Individual
- BS in Biostatistics
- Minimum of 5 years of relevant industrial experience
- Familiarity with R applications and DoE software packages
- Expert 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
- Service orientation towards internal customers
- High degree of self-motivation and commitment
- Strong communication skills, written and verbal
- Knowledge of related quality system regulations and processes.
- MS degree The Key Working Relationships Internal 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 Environment
- Typical office environment. However remote work may be part of
- Up to 100% of time at desk, standing or sitting extended
periods of time.
- Flexible work hours to meet project deadlines Salary
Transparency The 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. Equal Opportunity 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 firstname.lastname@example.org
Keywords: QuidelOrtho, Parsippany-Troy Hills Township , Senior Biostatistician, Other , Raritan, New Jersey
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