Sr Biostatistician

Universaldx; United States; Remote; USD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking company dedicated to revolutionizing cancer detection through innovative diagnostic tests. As a key player in the statistical planning and analysis for groundbreaking colorectal cancer screening tests, you will collaborate with a passionate team committed to making a significant societal impact. Your expertise in biostatistics and regulatory guidelines will guide the development of robust study protocols and ensure compliance with industry standards. This is an exciting opportunity to contribute to a mission-driven organization during a pivotal growth phase, where your work will directly influence the future of cancer diagnostics and treatment. Embrace the chance to make a difference in the fight against cancer!

Benefits

Remote work opportunities

Free day on your birthday

Parking incentive on office locations

Free cafe amenities on office locations

Possibility to buy extra vacation days

Optional health insurance plan

Annual Bonus up to 20% gross salary

Qualifications

• 5+ years of experience in biostatistics with a focus on analytical studies.
• Proficient in statistical programming tools like SAS, R, and Python.

Responsibilities

• Develop statistical analysis plans for assay development and validation.
• Perform advanced statistical analyses and provide data-driven insights.

Skills

Biostatistics

Statistical Analysis

Regulatory Guidelines

Collaboration

Statistical Programming (SAS, R, Python)

Analytical Development

Education

Master's in Biostatistics

Ph.D. in Statistics

Tools

SAS

R

Python

Job description

Reporting to the Director of Assay Development, this role will be instrumental in the planning and execution of statistical analyses for both development and analytical validation studies on Universal DX's screening test for colorectal cancer.
You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancer. As part of the team, you will be in a Company that aims to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and scaling our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

How you'll contribute

Study Design & Statistical Planning

• Develop and implement statistical analysis plans (SAPs) for assay development and validation studies.
• Collaborate with cross-functional teams to design robust study protocols, including endpoint selection, sample size calculations, and study acceptance criteria.

Statistical Analysis & Interpretation

• Perform advanced statistical analyses, ensuring the accurate and timely delivery of results.
• Provide data-driven insights to guide product development strategies.

Validation & Regulatory Support

• Lead statistical efforts for the design of analytical validation studies, including defining performance metrics such as precision, accuracy, and sensitivity.
• Contribute to regulatory submissions by preparing statistical reports, data summaries, and responses to agency queries.

Cross-Functional Collaboration

• Partner with internal teams, including Bioinformatics, Project Management, Quality Assurance, and Regulatory Affairs, to align activities with project milestones.
• Ensure alignment between statistical methodologies and regulatory/industry requirements (e.g., FDA, CLSI guidelines).

Documentation & Compliance

• Draft and review key technical documents, including SAPs, validation reports, and standard operating procedures (SOPs).
• Maintain compliance with quality management systems (QMS) and relevant regulatory guidelines.

Leadership & Mentorship

• Provide guidance and mentorship to junior biostatisticians.
• Lead cross-functional meetings to present statistical findings and methodologies.

Qualifications:

Required

• Master's or Ph.D. in Biostatistics, Statistics, or a related field.
• At least 5 years of experience in biostatistics, with a focus on analytical development and validation studies. Prior experience with designing development and analytical validation studies for NGS-based assays is strongly preferred.
• Proficiency in statistical programming methods/tools (e.g., SAS, R, Python).
• Strong understanding of regulatory guidelines for diagnostic product development (e.g., FDA, CLSI).
• Excellent collaborative skills and a strong willingness to be part of a dynamic team.
• Experience contributing to regulatory submissions, including 510(k)s or PMAs.
• Comfortable working in a fast-paced environment with the ability to adapt to shifting priorities.

Preferred

• Expertise in oncology, biomarkers, or diagnostic product development.
• Familiarity with Bayesian statistics, machine learning, or high-dimensional data analysis.

What we will offer

By being part of the team, you will be in a company that wants more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

Type of employment: Full-Time

GROSS ANNUAL SALARY: Based on experience

Annual Bonus: Up to 20% gross salary

Remote work opportunities
Free day on your birthday
Parking incentive on office locations
Free cafe amenities on office locations
Possibility to buy extra vacation days
Optional health insurance plan
And more

What does a successful person look like at Universal Diagnostics S.A.?

Those who thrive at Universal Diagnostics prioritize, manage, and execute their own goals with ownership. They embrace working in collaborative mode in a multi-cultural and multi-disciplinary environment that allows them to learn from others as well as share one’s own knowledge. They welcome and provide constructive feedback and criticism, trusting in the good intentions of others, and being secure in the knowledge that embracing mistakes is the best way to learn and grow. This position is meant for people who are driven by the opportunity to see their work having impact in the global fight against cancer.

Have any questions?

Apply now

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