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Sanofi Group Statistical Biomarker Leader, Associate Director in Bridgewater, New Jersey

Position Overview:

The role of Biomarkers in the clinical drug development process has an increasing importance because it can help to accelerate the clinical development process of a compound, to reduce R&D costs, and to bring better innovative drugs to patients. Therefore, the identification, analyses and use of Biomarkers in clinical studies become more and more important for informed decision-making processes.

The Statistical Biomarker Leader is involved in the clinical development process early on to lead the statistical aspects of the Biomarker discussions as part of the project team regarding identification and use of diagnostic, prognostic and predictive Biomarkers.

Do you have a degree in statistics, mathematics, or a related field? Are you familiar with the analyses of high dimensional/omics data? Do you have experiences in the clinical drug discovery process? Are you interested in leading Biomarker discussions in research and clinical development teams? Then the experienced and motivated Global Biomarker Statistics team within the Biostatistics & Programming (B&P) organization in US is the right place for you.

You will be reporting to the Global Head of Biomarker Statistics, who is looking forward to receiving your application.

Key Responsibilities:

  • Lead multiple complex projects for one or several indications of a project in clinical development phases starting from research regarding Biomarker statistical activities.

  • Provide appropriate input for the definition of the translational plan of the clinical development plan (e.g., identification or validation of drug target, identification of treatment responders) in collaboration with project team members.

  • Planning, analyzing and reporting of high dimensional/omics data for official and exploratory Biomarker analyses.

  • Promote and implement use of statistical methods for high dimensional data (e.g. clustering, SVM, random forest, deep learning) on biomarker omics datasets (transcriptomics, genomics, metabolomics).

  • Develop, promote and implement biomarkers-driven designs and analyses to improve decision making and optimize clinical development.

  • Define Biomarker Statistical Analyses Plans using state-of-the-art methodology.

  • Develop and maintain strong working relationship with official Early and Late Phase Project Statisticians, Study Lead Statisticians, and related functions.

  • Keep knowledge about new technical, statistical and methodological developments and discuss use for internal clinical data/studies/projects.

  • Represents statistics in regulatory meetings for biomarker topics.

  • Represent statistics to participate (and lead if applicable) in scientific or technology working groups or cross function initiatives.

  • Provide technical guidance and mentoring to junior staff.

  • Effectively utilize external groups, e.g. CROs.

  • Contribute to operation process optimization and provide inputs to statistics standards in biomarker field.

  • Promote teamwork, quality, operational efficiency, and innovation.

Qualifications & Requirements:

  • PhD/MS in Statistics, Mathematics, Computer Science or related discipline with a minimum of 6 years of pharmaceutical experience.

  • Broad knowledge and good understanding of advanced statistical concepts and techniques, in particular high-dimensional statistics.

  • Strong knowledge of R.

  • Expertise in omics data bioinformatics and statistical analysis.

  • Experience in Machine Learning algorithms: penalized regression, SVM, random forest.

  • Demonstrated strong study management, interpersonal and communication skills.

  • Broad knowledge of pharmaceutical clinical development.

  • Broad Biomarker knowledge.

  • Proven experience in clinical development, interactions with regulatory agencies or other external stakeholders.

  • Ability to represent Sanofi in cross-company activities such as consortiums or professional associations.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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