Senior R&D Biostatistician

We are seeking a Senior Biostatistician to join the R&D New Product Development team. The candidate will bring biostatistical skills in combination with knowledge of diagnostic product development and licensing (USDA preferred) to support the development and licensing of new products for diagnostic testing applications. The role as a Technical Product Registration Biostatistician provides a chance to participate as part of a technically focused R&D team, with close collaboration with others in R&D, Regulatory Affairs, and the Commercial Medical Organization. This role requires a seasoned, experienced professional with a full understanding of area of specialization. This job is a fully qualified, career-oriented, journey-level position.

The successful candidate will develop and recommend appropriate statistical methodology, experimental structure, analysis and data visualization utilizing statistical software and other tools, for USDA and international licensing protocols, studies, and reports. The candidate will help to design/generate study protocols and reports for the licensing of diagnostic assays. To be successful in this role the candidate should be highly motivated, detail oriented, and excel in a highly collaborative and multi-disciplinary environment. They will also be expected to consistently apply discretion and sound judgement towards the work they undertake and resolve a wide range of issues in creative ways. Degree of complexity will vary between products and the level of autonomy granted will depend on the level of product/study experience.

***At this time, we will not be able to offer sponsorship for this role, either now or in the future.***

What will you do?

• Develop and recommend statistical designs, methods, and procedures for USDA and international product registration protocols-including the associated data submission packages critical for successful licensure of new diagnostic products.

• Develops, recommends, and contributes to statistical designs, methods, and experimental structure, data analysis and data visualization for design, development, verification and validation of new products to ensure the quality and timeliness of the new product development (NPD) process.

• Develops, recommends, and contributes to statistical designs, methods, and experimental structure for field trials, beta testing and complex validation and/or reliability testing.

• Contributes to defining standard statistical designs for experimental practices based on established USDA and international product licensing guidelines, for NPD and R&D.

• Collaborates with NPD Design and Development Teams, Process Development Teams, R&D Engineering, Regulatory Affairs, and other internal and external stakeholders.

• Analyzes, summarizes, and presents information and data in text and graphical forms for discussion and decision making within the organization. Presents ideas, data and analysis to other parts of the organization for feedback on feasibility and concept.

• Assists project teams within NPD determining critical design inputs, experimental structure and establishing best practice. Works with technical leads, core team leads and other project managers.

What do you need to succeed?

• PhD preferred with 3-5 years of relevant experience or MS with 6-8 years of relevant experience

• Relevant experience in a regulated bio-tech industry is required.

• Knowledge and experience with statistical programming, (SAS, R, etc.) and proficiency with EXCEL and JMP/Minitab or equivalent statistical software.

• Knowledge of standard statistical methods, generalized linear models, categorical data analysis, survival analysis, sample size determination and experimental design including response surface, mixture designs, fractional factorial screening designs, split plots and full factorials.

• Results oriented, self-starter with good analytical and problem-solving skills. Demonstrated ability to work collaboratively with research and engineering teams. Ability to frame a complex scientific question appropriately, develop an analytical strategy, assemble the relevant data and results to clearly communicate a coherent set of conclusions.

• Demonstrated ability to produce written reports that succinctly describe the study purpose, experimental structure, statistical analysis, conclusions, and recommendations. Excellent skills in data communication and visualization.

• Works on problems of diverse scope, where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Work context involves novel and variable situations requiring analytical and creative thinking.

• Strong ability to work collaboratively with regulatory agency statisticians. Excellent teaching ability: can communicate complex statistical methods and results in a manner that is understandable to recipients of statistical analyses.

• Demonstrated ability to influence without authority. Strong communication and interpersonal skills. Ability to plan both short- and long-term schedules to achieve goals.

• Management experience a plus.

***At this time, we will not be able to offer sponsorship for this role, either now or in the future.***

What you can expect from us:

• Salary range starting at $100,000 based on experience

• Opportunity for annual cash bonus

• Health / Dental / Vision Benefits Day-One

• 5% matching 401k

• Additionalbenefits including but not limited to financial support, pet insurance, mentalhealth resources, volunteer paid days off, employee stock program, foundation donationmatching, and much more

Ifyou'relooking for a rolethat'llchallenge you, offer a variety of work and learning, while helping an amazing industry,we'dlove to hear from you!

Why IDEXX:

We're proud of the work we do because our work matters. An innovation leader in every industry we serve, we follow our Purpose and Guiding Principles to help pet owners worldwide keep their companion animals healthy and happy, to ensure safe drinking water for billions, and to help farmers protect livestock and poultry from disease. We have customers in over 175 countries and a global workforce of over 10,000 talented people.

So, what does that mean for you? We enrich the livelihoods of our employees with a positive and respectful work culture that embraces challenges and encourages learning and discovery. At IDEXX, you will be supported by competitive compensation, incentives, and benefits while enjoying purposeful work that drives improvement.

Let's pursue what matters together.

About the job location:

If you're thinking about relocating for this role, here are a few things to know about living in Maine (often called "Vacationland"). The Westbrook, ME area provides great access to active downtown areas and the outdoors, with the coast and numerous mountains and hiking trails nearby. You'll also find a number of large companies like ours in the area, creating a vibrant work culture.

You can learn more on the Portland tourism website: https://www.visitportland.com/visit/resources/moving-to-maine/

IDEXX values a diverse workforce and workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply.

IDEXX is an equal opportunity employer. Applicants will not be discriminated against because of race, color, creed, sex, sexual orientation, gender identity or expression, age, religion, national origin, citizenship status, disability, ancestry, marital status, veteran status, medical condition, or any protected category prohibited by local, state, or federal laws.

While we appreciate our staffing partners, we are unable to accept unsolicited agency resumes.

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