This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Lead Biostatistician (IVD Clinical) based in United States.
This role offers the opportunity to contribute to the advancement of innovative molecular diagnostic products that have the potential to transform patient care.
As a Lead Biostatistician, you will play a key role in designing, analyzing, and interpreting clinical trial data supporting regulatory submissions.
You will collaborate with multidisciplinary teams across science, medicine, engineering, and regulatory functions to deliver high-quality statistical insights.
The position combines advanced statistical expertise with real-world clinical application in a fast-paced diagnostics environment.
You will influence study strategies, mentor colleagues, and help ensure rigorous evidence generation for next-generation healthcare solutions.
This is an impactful opportunity for a skilled statistician who is passionate about applying data-driven approaches to improve health outcomes.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Lead Biostatistician (IVD Clinical) based in United States.
This role offers the opportunity to contribute to the advancement of innovative molecular diagnostic products that have the potential to transform patient care.
As a Lead Biostatistician, you will play a key role in designing, analyzing, and interpreting clinical trial data supporting regulatory submissions.
You will collaborate with multidisciplinary teams across science, medicine, engineering, and regulatory functions to deliver high-quality statistical insights.
The position combines advanced statistical expertise with real-world clinical application in a fast-paced diagnostics environment.
You will influence study strategies, mentor colleagues, and help ensure rigorous evidence generation for next-generation healthcare solutions.
This is an impactful opportunity for a skilled statistician who is passionate about applying data-driven approaches to improve health outcomes.
Accountabilities:
- Design, review, and provide statistical input for clinical study protocols and statistical analysis plans.
- Lead the execution of statistical analyses according to predefined plans, protocols, and regulatory requirements, including exploratory and ad-hoc analyses.
- Develop high-quality statistical documentation, presentations, and reports detailing methodologies, results, and interpretations.
- Communicate complex statistical concepts and findings clearly to technical and non-technical stakeholders.
- Identify statistical risks, raise critical issues, and recommend solutions within cross-functional project teams.
- Support regulatory submission activities by ensuring robust statistical methodologies and analysis approaches.
- Mentor and provide technical guidance to junior team members, helping strengthen statistical capabilities across the organization.
- Contribute to continuous improvement initiatives and perform additional responsibilities as needed.
- Master’s degree in Biostatistics, Statistics, or a related quantitative field with 5+ years of relevant experience, or PhD with 3+ years of relevant experience.
- 3+ years of hands-on experience designing and executing statistical analyses for clinical trials in a regulated environment.
- Strong experience using statistical analysis software such as R, SAS, or JMP, with preference for R expertise.
- Previous experience in diagnostics, molecular testing, oncology, or related healthcare fields is preferred.
- Expert understanding of probability theory, statistical methods, and their practical application in clinical research.
- Familiarity with clinical trial design principles, industry best practices, and regulatory standards.
- Experience working with next-generation sequencing (NGS), genetics, and/or oncology testing is a plus.
- Prior experience interacting with regulatory organizations such as the FDA is preferred.
- Strong written and verbal communication skills, with the ability to explain complex statistical concepts to varied audiences.
- Demonstrated ability to collaborate effectively across multidisciplinary teams and produce high-quality documentation.
- Competitive compensation package with a salary range of $144,000 - $180,000 USD.
- Annual performance incentive bonus opportunities.
- Long-term equity awards.
- Comprehensive medical, dental, and vision coverage.
- 401(k) plan with company matching contributions.
- Generous paid time off and company holidays.
- Wellness programs and additional work-life support benefits.
- Opportunities to work on innovative healthcare technologies with meaningful patient impact.
- Collaborative environment with opportunities for professional growth and development.
As a Lead Biostatistician, you will provide statistical leadership across clinical development activities, supporting study design, execution, analysis, and regulatory documentation. You will partner with cross-functional teams to translate complex data into meaningful insights while ensuring compliance with clinical research standards.
Requirements:
The ideal candidate is an experienced biostatistics professional with strong expertise in clinical research, regulated environments, and statistical methodology. You should have the ability to independently lead complex analyses while collaborating effectively with diverse scientific and technical teams.