TA Head of Biostatistics, Neuroscience and Ophthalmology

Job Title: Data Governance

Location: Cambridge, MA Morristown, NJ

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 Biostatistics Neuroscience and Ophthalmology teamas Global Head of Neuroscience and Ophthalmology TA Biostatistics. You will beleading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies, submission planning, and trial methodologies. In this influential and collaborative role, the Biostatistics TA Head partners closely with clinical teams, Clinical Sciences & Operations (CSO), regulatory experts, and key stakeholders to accelerate the delivery of medicines to patients. Within our department of Evidence Generation and Decision Science (EGDS), you’ll be supported by a Biostatistics group that fosters people development, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients’ lives.

We’re an R&D-driven, AI-powered biopharma company with one purpose: to chase the miracles of science to improve people’s lives. Combining deep immunoscience expertise with cutting-edge research and development, we drive transformative breakthroughs that redefine the practice of medicine. Together, we’re building a healthier, more resilient world by turning the impossible into the possible – discovering, developing, and delivering life-changing medicines and vaccines to millions worldwide.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main 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 , Translational 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

About You

• 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.

• undefined

• 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).

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 a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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.

#GD-SA

Ensure you read the information regarding this opportunity thoroughly before making an application.
#LI-SA

#LI-Hybrid
#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.