Translational Lead Biostatistician

Job Title: Translational Lead Biostatistician

Location: Morristown, NJ

About the Job

Within Translational and Early Development (TED) team under GBS in Sanofi Vaccine Business, provide statistical expertise and guidance to translational activities in clinical platform studies and beyond with minimal supervision. In this role, he/she will work in close collaboration with cross-functional teams including the global clinical development translational strategic experts (GCDSE), the biomarker experts, clinical study team, CMC, immunology and research experts from the corresponding projects.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

Provide in-depth statisitical expertise on translational activities across different functions in clinical studies and beyond.   

• Lead statistical aspects on translational strategy of clinical development plans and protocol developments.

• Strategic plan on cross-trial analysis to gain insight of impacts of different antigens, LNPs, mRNA formulations, as well as other population factors (age, gender, sites, …)

• Prepare exploratory statistical analysis plan (SAP) with integrated analysis on multiple sources of clinical readouts.

• Perform innovative and high-quality statistical support to new types of exploratory variables using advanced assay/platform.

• Provide statistical guidance on exploratory assay development/characterization in collaboration with internal and external biomarker labs. Ensure the consistency of assay performance across different labs.  

• Conduct research on sophisticated methods for biomarker analyses including next generation sequencing data, network analysis and pathway/enrichment analysis.

• Develop the annex (CSR-like) reports with translational study team and medical writers.

• Collaborate with cross functional collaborators including but not limited to Research, CMC, clinical assay testing, GCDSE and biomarker expert to deep dive on the key compenents which may impact the efficacy .  

• Apply/develop novel solutions to address challenge technical problems.  Generate technical reports and publication manuscripts. Representing company to present at external conferences. 

• Promote quality and productivity through the development and deliver automated statistical tools.

About You

• Earned PhD in statistics/biostatistics or scientific field.

• Minimum of 2.5 years of post-doc, industry or medical experience in translational medicine, translational analysis or related field.

• Demonstrated strong project/clinical study management experience is required

• Broad knowledge and in-depth understanding with ability to apply advance statistical methods related to transitional medicine is needed.

• Ability to represent Sanofi in cross-company working groups such as consortiums and professional associations, including compiling and presenting scientific data is vital.

• Records of publications in statistical peer reviewed journals is highly preferred.

• Hands-on and detail oriented to develop Statistical Analysis Plans, conduct statistical analysis and deliver reports/presentations.

• Strong statistical computing skills and able to conduct simulations and statistical analysis without programming support.

• Proven interpersonal relationship and written/verbal communication skills.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy