TA Head of Biostatistics, Neuroscience and Ophthalmology

Role Summary

TA Head of Biostatistics, Neuroscience and Ophthalmology

Responsibilities

• Define and drive the strategic vision for the Biostatistics TA, building and sustaining a industry-leading organization. Develop and maintain deep expertise in disease areas within the Neuroscience and Ophthalmology TA
• Responsible for high quality and timely statistical deliverables for the Neuroscience and Ophthalmology TA, from clinical development plan inception to approval by regulatory bodies as applicable, ensuring project teams are provided with strong statistical scientific leadership and state-of-the-art operational support
• Proactively cultivate strong partnerships with TA, Clinical Science Organization (CSO) leadership, Regulatory, Transnational Medicine Unit (TMU), Patient Informed Development and Health Value Transition (PID/HVT) leadership members to promote teamwork and advance statistical leadership and strategic influence in planning and decision making; Cultivate effective collaboration & communication models to consolidate and sustain various data and analytic efforts within and outside the EGDS department
• Effectively manage resources and staffing to bring synergy and efficiency. Collaborate with other functions to explore diverse, cost-effective sourcing options to nurture nimble and motivated teamwork and ensure efficient, high-quality deliverables
• Maintain strong external visibility in the statistics community by representing Sanofi on cutting-edge statistical topics and innovations. Participate in major conferences and workshops across industry and academia to support the presentation of Sanofi data and the evaluation of scientific development. Represent Sanofi statistics in high-stake regulatory meetings, key scientific or technology working groups
• Member of department senior leadership team, working with Department Head and other EGDS Heads to identify, prioritize, and lead key EGDS departmental development initiatives

Qualifications

• PhD in Statistics or Biostatistics with typically at least 12 years of pharmaceutical experience in clinical development within pharma or biotech industry, including significant senior-level experience and a strong focus on TA and TA-enabling strategy. Leadership experience in Neuroscience clinical development is required.
• Excellent knowledge and understanding of FDA and EMA guidance relevant to the TA, clinical development, and advanced statistical concepts and techniques, including Adaptive designs, Bayesian methods, multiplicity, subgroup identification, precision medicine. Demonstrated expertise in interpreting and advising on medical matters.
• Proven successful experience and competencies in clinical development or post-marketing activities such as submissions, interactions with regulatory agencies (including NDA/BLA and EMA filings) or other external stakeholders.
• Keep up with evolving evidence generation, decision sciences and digital technology, keen for their fit-for-purpose application in clinical development across diverse therapeutic areas. Proven capability in innovation and creativity
• Demonstrated leadership and excellent interpersonal/communication, strategic thinking, change management and people management skills. Experience in leading high-performing teams and cultivating top talents through strategic hiring, development, and retention.
• Proven ability to engage and influence executives, regulators, and key stakeholders. Exhibited expertise to represent organizations in cross-company activities (e.g. consortiums or professional associations).

Skills

• Strategic leadership in biostatistics for neuroscience and ophthalmology
• Regulatory interactions and submissions experience
• Advanced statistical methods (adaptive designs, Bayesian methods, multiplicity, precision medicine)
• Cross-functional collaboration and stakeholder management
• People leadership and talent development

Education

• PhD in Statistics or Biostatistics