Statistical Project Leader, Clinical Biomarkers

Sanofi; Vitry-sur-Seine; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

A leading biopharma company is seeking a Statistical Project Leader for Clinical Biomarkers to oversee statistical activities in the clinical development process. This role involves leading projects related to biomarker data, implementing innovative analysis tools, and ensuring cross-functional collaboration. A PhD/MS in statistics with at least 6 years of pharmaceutical experience is required. This position offers a hybrid work model and an opportunity to significantly impact drug development.

Prestations

Opportunities for collaboration across diverse teams

Cutting-edge AI and digital platforms for drug discovery

Qualifications

• Minimum of 6 years of pharmaceutical experience.
• Experience with clinical development and decision-making processes.

Responsabilités

• Lead statistical activities in clinical development phases.
• Implement data analytical tools and methodologies.
• Ensure collaboration with project teams and communication with leadership.
• Represent statistics in regulatory meetings.

Connaissances

Strong study management

Communication skills

Knowledge of statistical concepts

Experience with biomarker data

Leadership skills

Formation

PhD/MS in statistics or related discipline

Description du poste

Job title: Statistical Project Leader, Clinical Biomarkers

• Location: Vitry OR Montpellier

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Evidence generation and decision science team as Statistical Biomarker Lead and you can help make it happen.

Your job is involved in the clinical development process from early on to lead the statistical aspects of the biomarker discussions as part of the clinical project team and is responsible for generation of actionable data-driven insights from clinical biomarkers to optimize targeted patient population and increase the productivity of drug development in one or more therapeutic areas (e.g., oncology, immunology, neurology, rare disease, and rare blood disorders).

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

• Lead in multiple complex projects/one or several indications of a project in clinical development phases with regard to statistical activities in Precision Medicine and Biomarker activities
• Leverage biomarker data/evidence from different source (e.g., pre-clinical data, RWE, publications) and provide appropriate input for the development of the biomarker strategy of a clinical project in collaboration with project team members
• Implement innovative data analytical tools (e.g., AI, machine learning) and statistical methodologies to transform the complex biomarker data into insights that can be readily used in drug development
• Planning, analyzing and reporting of various of biomarker data (e.g., biomarker profiles, genome-wide datasets, medical imaging data, continuous data from wearable devices) collected from clinical studies for both formal reporting and exploratory analyses purposes
• Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership
• Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment
• Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas. Capacity to respond to unscheduled increase in project workload. Ensure project team compliance with SOPs and departmental standards
• Represents statistics in regulatory meetings for biomarker topics
• Represent statistics to participate (and lead if applicable) in scientific or technology working groups or cross-functional initiatives
• Provide technical guidance and mentoring to junior staff

About you

Education and Experience:

• PhD/MS in statistics or related discipline with a minimum of 6 years of pharmaceutical experience

Technical & Soft skills

• Demonstrated strong study management, interpersonal and communication skills
• Broad knowledge and good understanding of advanced statistical concepts and techniques in various biomarker data collected in clinical studies
• General knowledge of pharmaceutical clinical development and the process of clinical decision making; experience of using biomarker data in clinical decision-making process is desired
• Broad Biomarker knowledge
• Proven experience in clinical development, interactions with regulatory agencies or other external stakeholders is desired
• Ability to represent Sanofi in cross-company activities such a consortiums or professional associations

Languages

• Fluent in English

Why choose us?

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science
• Help improve the lives of millions of people globally by making drug development quicker and more effective
• Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

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