Biostatistician- Vaccines

Sanofi - Swiftwater, PA

Full-time - Entry Level

Swiftwater, PA

10,001+ employees

Chemical Manufacturing

About the position

The Biostatistician role in the Translational and Early Development (TED) Biostatistics team supports Vaccine R&D across various stages including preclinical studies, clinical bioassay technology, and CMC. This position involves providing statistical support for research and development activities, collaborating closely with scientists and clinical project teams to ensure appropriate statistical methods are applied, and addressing statistical inquiries from regulatory agencies.

Responsibilities

• Act as the study statistician to support activities under TED scope.
• Support clinical bioassays in phase 1/2 to phase 3 clinical studies.
• Assist in clinical assay qualification and validation, and statistical assay performance assessments.
• Collaborate with global clinical immunology and project teams to address regulatory agency questions related to clinical assay platforms.
• Develop a digital mindset and statistical thinking with key stakeholders.
• Support the digital evolution of bioassay technology advancement.
• Provide statistical support throughout the evolution from initial qualification to assay performance monitoring during clinical studies.
• Generate statistical deliverables and co-author documentation for regulatory submissions.
• Perform statistical analyses, report generation, and results interpretation.
• Develop statistical tools (such as R Shiny) to automate standardized statistical activities.

Requirements

• Ph.D. in statistics or biostatistics.
• Pharmaceutical experience is highly desirable.
• Ability to apply innovative statistical methods in study design and data analysis.
• Motivated to conduct research for developing new methods.
• Excellent communication and consultation skills to explain statistics to non-statisticians.
• Effective project/study management skills to maintain timelines and high-quality deliverables.
• Proficiency in statistical computing languages including R and SAS.
• Familiarity with UNIX computing and cloud environments.
• Experience in parallel computing is a strong plus.
• Competency in English, both oral and written.

Nice-to-haves

• Experience in vaccine research and development.
• Familiarity with regulatory submission processes.
• Knowledge of advanced statistical methodologies.

Benefits

• High-quality healthcare coverage.
• Prevention and wellness programs.
• At least 14 weeks' gender-neutral parental leave.