Senior Biostatistician

$164,670 - $200,000/Yr

Antech Diagnostics - Loveland, CO

Full-time - Mid Level

Hybrid - Loveland, CO

Professional, Scientific, and Technical Services

About the position

The Senior Biostatistician at Antech Diagnostics plays a vital role in the Veterinary Diagnostics R&D team, focusing on designing studies, analyzing data, and preparing regulatory submissions for diagnostic products. This position directly contributes to the development of reliable diagnostic tests that enhance animal care, aligning with the company's mission of improving pet health.

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.
• Prepare regulatory submission documents, including writing statistical analysis sections adhering to CVB-USDA guidelines and ensuring compliance with other regulatory requirements.
• Conduct risk analysis and mitigation by identifying potential issues affecting test reliability and validity and developing strategies to mitigate risks through statistical analysis and process improvement.
• Collaborate closely with Regulatory Affairs to strategize data presentation in submissions and ensure alignment of statistical analysis with regulatory goals.
• 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.

Requirements

• 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.

Nice-to-haves

• 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.
• Independence and Teamwork: Proven ability to work independently with minimal supervision, as well as part of a multidisciplinary team.
• Communication Skills: Excellent verbal and written communication skills for effective collaboration and presentation of statistical methods.
• Positive Attitude: A positive, can-do and problem-solving attitude, ready to tackle challenges.
• Regulatory Knowledge: Knowledge of Good Clinical Practice (GCP) and other regulatory requirements relevant to veterinary diagnostics and clinical trials.
• Safety Practices: Knowledge of personal protective equipment (PPE) and its use to prevent exposure to zoonotic infectious agents.
• Computer Proficiency: Strong personal computer skills, including proficient use of Microsoft Office Suite.

Benefits

• 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