Senior Biostatistician

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.

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.

• Performs 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.

• Designs databases.

• Perform other work-related duties as assigned.

Required:

• 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 matrix organization.

• 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.

Preferred:

• MS degree

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.

• Typical 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 deadlines

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.

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 recruiting@quidelortho.com.

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