Associate Director/Director, Computational Test Development

About the role

The Associate Director/Director, Computational Test Development is responsible for leading the computational aspects of IVD test development, ensuring that all projects are aligned with regulatory requirements and deliver high-quality results.

Responsibilities

• Lead the computational aspects of IVD test development, including algorithm design, data analysis, and model validation.
• Collaborate with cross-functional teams to ensure that computational outputs meet regulatory standards and clinical utility.
• Develop and maintain computational pipelines and tools for efficient and accurate test development.
• Provide technical guidance and mentorship to junior team members.
• Contribute to the strategic planning and execution of computational initiatives within the department.

Requirements

• Bachelor's degree in Computer Science, Biostatistics, Bioinformatics, or a related field.
• Minimum 7 years of relevant experience in computational test development, with a strong focus on IVD testing.
• Experience with statistical software such as R, Python, SAS, or MATLAB.
• Knowledge of FDA guidelines and regulations for IVD devices.
• Strong problem-solving skills and ability to work independently and collaboratively.
• Excellent communication and presentation skills.

Qualifications

• Master's degree in Computer Science, Biostatistics, Bioinformatics, or a related field.
• Experience leading large-scale computational projects.
• Proven track record of delivering high-quality computational solutions for IVD tests.
• Experience with cloud-based computing platforms like AWS or Google Cloud.
• Ability to manage multiple projects simultaneously and prioritize tasks effectively.

Skills

• Proficiency in programming languages such as R, Python, and SQL.
• Experience with machine learning algorithms and statistical methods.
• Understanding of IVD device development processes and FDA guidelines.
• Experience with version control systems like Git.
• Strong analytical and problem-solving skills.

Benefits

• Competitive salary commensurate with experience.
• Flexible work schedule with the option to work from home.
• Health insurance coverage.
• Retirement savings plan.
• Professional development opportunities.

Pay

Salary is competitive and commensurate with experience.

Schedule

This position is a full-time, hybrid role requiring at least three days of in-office work per week.