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 an Associate Biostatistician to provide statistical support under the supervision of the Biostatistics leadership. This role primarily helps in the acquisition or extraction of data from various sources, performs basic data analyses, and assists with the preparation of presentations and publications. This person would assist quality control with provision of advanced statistical methods, support and refine product complaint analyses, and manufacturing efficiencies.

This role will be onsite in Rochester, NY.

The Position

Performs statistical analysis in accordance with protocol and contribute the report from statistical perspective.Performs QC 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).Supports development, optimization, verification and validation of data reduction and check 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.Provides statistical support to business to influence and facilitate strategic decision making.Documents results according to established company practices and procedures.Conducts data review; writes reports and presents analyses and interpretations to other members of the R&D group.Responsible for statistical experimental design (DOE), data analysis and interpretation.Responsible for sample size determinations, calculations of clinical accuracy, PPV, NPV, and other statistics of value for clinical trials and regulatory submissions.Performs statistical modeling under the supervision of biostatistical leadership.Executes all tasks in accordance with QuidelOrtho’s Quality System and carries out duties in compliance with established business policies.Perform other work-related duties as assigned.

The Individual

Required:

Bachelor’s degree in Biostatistics, Statistics, or related Quantitative SciencesFamiliarity 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.Ability to travel up to 5-10%

Preferred:

MS in Biostatistics, Statistics, or related Quantitative Sciences1-3 years of relevant industry experience with demonstrated progressively increasing responsibility

The Key Stakeholders

Internal Partners:

Cross Interacts cross-functionally (R&D, Clinical/Regulatory, Quality, Engineering and Manufacturing) and companywide, on a continual basis presenting statistical expertise on product development projects.

External Partners:

Outside clinical testing laboratories

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Flexible work hours to meet project deadlines.

Physical Demands

Position requires ability to lift up to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.

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 $75,000 to $85,000. 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 the 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.