Senior Biostatistician

Accountabilities: As a Senior Biostatistician, you will provide statistical expertise across clinical and analytical studies, ensuring robust study design, accurate analysis, and regulatory compliance throughout the development of diagnostic products.

• Lead end-to-end statistical support for clinical studies, including study design, sample size determination, analysis, interpretation, and reporting.
• Apply advanced statistical methodologies such as multivariate analysis, classification techniques, survival analysis, and general linear modeling to support product development.
• Develop and author statistical sections of clinical protocols, statistical analysis plans, clinical study reports, and regulatory submission documents.
• Provide expert guidance on study design considerations, statistical risks, sampling strategies, and power calculations.
• Support analytical performance studies including precision, reproducibility, method comparison, linearity, accuracy, limit of detection, inclusivity, exclusivity, and interference assessments.
• Serve as a key statistical contact for regulatory inquiries and contribute to interactions with regulatory agencies.
• Review and improve standard operating procedures while delivering statistical training and knowledge-sharing initiatives across teams.
• Participate in audits and ensure statistical activities meet regulatory and quality standards.

Requirements

The ideal candidate brings strong biostatistical expertise, regulatory knowledge, and experience supporting clinical studies within highly regulated healthcare or diagnostics environments.

• Bachelor's degree in Statistics or Biostatistics with 8+ years of experience, or Master's degree with 6–8 years of experience, or PhD with 4+ years of experience.
• Proven experience as a lead statistician supporting IVD, medical device, imaging, or related clinical studies in regulated environments.
• Strong understanding of global regulatory frameworks and industry standards, including FDA, CE-IVDR, WHO, CLSI, and related guidelines.
• Proficiency with statistical and analytical tools such as SAS, R, Python, Minitab, and Excel.
• Experience designing and analyzing clinical studies, including regulatory submission support.
• Ability to translate complex scientific, engineering, and business challenges into practical statistical approaches.
• Excellent written and verbal communication skills, including the ability to present technical findings to non-statistical stakeholders.
• Strong analytical thinking, attention to detail, and problem-solving capabilities.
• Experience supporting regulatory submissions and interactions with regulatory authorities is highly desirable.

Benefits

• Competitive compensation and comprehensive benefits package.
• Remote working flexibility with access to global teams and projects.
• Opportunity to contribute to life-changing healthcare and diagnostic innovations.
• Exposure to cutting-edge technologies and scientific advancements in diagnostics and biotechnology.
• Collaborative and inclusive work environment that values continuous improvement and professional growth.
• Learning, development, and career advancement opportunities within a global organization.
• Paid time off, health and wellness programs, and additional employee support benefits.
• Opportunity to work alongside multidisciplinary experts across clinical, scientific, regulatory, and technical domains.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether?

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