We understand that the world we want tomorrow starts with how we do business today, and that’s why we’re inspired to make A Better World for Pets. Antech is comprised of a diverse team of individuals who are committed to each other’s growth and development. Our culture is centered on our guiding philosophy, The Five Principles: Quality, Responsibility, Mutuality, Efficiency and Freedom. Today Antech is driving the future of pet health as part of Mars Science & Diagnostics, a family-owned company focused on veterinary care.Current Associates will need to apply through the internal career site. Please log into Workday and click on Menu or View All Apps, select the Jobs Hub app, then click the magnifying glass to Browse Jobs.Work Type: HybridThis is a Hybrid role based out of our Hub located in Loveland, Colorado.The Target Pay Range for this position is $164,670 - $200,000 annually. At Antech, pay decisions are determined using factors such as relevant job-related skills, experience, education, training and budget.Job Purpose/OverviewAs a Biostatistician on our Veterinary Diagnostics R&D team, you’ll play a crucial role in designing studies, analyzing data, and preparing regulatory submissions for our diagnostic products. Your work will directly contribute to the development of reliable, accurate diagnostic tests that enhance animal care supporting our purpose of helping make the world a better place for pets.Essential Duties and Responsibilities
Design studies for evaluating the accuracy of diagnostic tests, including determining study design, experimental parameters, sample sizes, randomization methods, and statistical analyses.
Develop and validate statistical methodologies for analyzing and interpreting diagnostic test data, including clinical trial study data, focusing on sensitivity, specificity, accuracy, predictive values, and reference intervals.
Provide statistical expertise in the development and optimization of diagnostic assays and algorithms, quality control procedures and protocols, and product specifications.
Design, conduct, and analyze studies to evaluate the performance of diagnostic tests.
Analyze complex data sets, drawing meaningful conclusions and making recommendations to improve test performance.
Generate comprehensive statistical reports, tables, listings, and figures (TLFs) for clinical trials and research studies; contributing authorship of internal reports, position statements, presentations, and peer-reviewed publications.
Extract data from Laboratory Information Systems (LIS) and generate insightful dashboards in Tableau.
Preparing regulatory submission Documents:
Write statical analysis sections adhering to CVB-USDA guidelines.
Ensure compliance with other regulatory requirements
Assist in preparing submission documents for regulatory approval.
Conduct Risk analysis and mitigation:
Identify potential issues affecting test reliability and validity
Develop strategies to mitigate risks through statistical analysis and process improvement.
Collaboration and regulatory affairs:
Work closely with Regulatory affairs to strategize data presentation in submission.
Ensure alignment of statistical analysis with regulatory goals.
Work closely with product development, quality assurance, and regulatory affairs teams to align statistical analyses with product goals and regulatory strategies.
Analyze post-market data to monitor product performance, contributing to corrective actions or enhancements based on analysis.
Provide training and mentorship on statistical methods, data analysis techniques, and regulatory requirements.
Stay updated on advances in diagnostic technologies and statistical methods relevant to veterinary diagnostics.
Contribute to research projects and publications, advancing the understanding of diagnostic testing methodologies.
Uphold and promote the ethical standards and values of the organization.
Education and Experience
Advanced degree in Biostatistics, Statistics, or a related field.
Experience in study design, sample size calculation, and statistical analysis in the context of diagnostic testing or clinical trials.
Proficiency in statistical software and tools, with a strong preference for candidates experienced in Tableau. (R Studio a bonus).
Demonstrated ability to analyze and interpret complex data sets.
Excellent report-writing and communication skills.
Demonstrated Ability to work collaboratively within a multidisciplinary team.
Knowledge, Skills and Abilities
General Science Background : Solid understanding of cellular biology, basic nucleic acid biochemistry, and the biology of diseases, with a focus on applications in diagnostic test development.
Attention to Detail : Exceptional attention to detail to ensure accuracy in statistical analysis and data interpretation.
Organizational Skills : Highly organized with the ability to multitask effectively in a fast-paced R&D environment. Capable of managing multiple projects and priorities without compromising quality or timelines.
Independence and Teamwork : Proven ability to work independently with minimal supervision, as well as part of a multidisciplinary team. Must demonstrate initiative and the ability to contribute positively to team dynamics.
Communication Skills : Excellent verbal and written communication skills are essential for effective collaboration with team members, preparation of comprehensive reports, presentation of statistical methods, study results, and conclusions to a variety of different stakeholders, and contributions to scientific publications.
Positive Attitude : A positive, can-do and problem-solving attitude, ready to tackle challenges and contribute to a constructive and innovative work environment.
Regulatory Knowledge : Knowledge of Good Clinical Practice (GCP) and other regulatory requirements relevant to veterinary diagnostics and clinical trials. Familiarity with FDA submission processes is a plus.
Safety Practices : Knowledge of personal protective equipment (PPE) and its use to prevent exposure to zoonotic infectious agents. Commitment to maintaining a safe work environment is essential.
Computer Proficiency : Strong personal computer skills, including proficient use of Microsoft Office Suite. Ability to quickly learn and utilize statistical software, database management systems, and visualization tools like Tableau.
TravelPercent of time: 25 %Working Conditions
Capable of standing continuously for up to 2 hours
Extend and reach with hands and arms and use hands and fingers
Occasionally required to bend, kneel, stoop, or crouch
May be required to lift, move, and carry up to 50 lbs
Specific vision abilities required include close vision, color vision, depth perception, and the ability to adjust focus.
Hearing ability to effectively communicate via the telephone and in person
Ability to communicate verbally on the phone and in person
Fluency in the English language
Extended hours may be needed
Laboratory environment with potential biohazards present that are mitigated by the mandatory use of PPE.
Works with a collaborative attitude with multiple teams in parallel.
Antech offers an industry competitive benefits package and continues to invest in and evolve benefits programs that meet the health, wellness and financial needs of our associates.
All Full-time associates are eligible for the following benefits and more:
Paid Time Off & Holidays
Medical, Dental, Vision (Multiple Plans Available)
Basic Life (Company Paid) & Supplemental Life
Short and Long Term Disability (Company Paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts
We are proud to be an Equal Opportunity Employer - Veterans / Disabled. For a complete EEO statement, please see our Career page at Antech Careers (http://careers.antechdiagnostics.com/us/en/affirmative-action) .