Senior Biostatistician

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.

As 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.

Education and Experience

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.

Travel

Percent 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.