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Sanofi Group Global Head Biostatistics - Vaccines in Swiftwater, Pennsylvania

Position Overview:

The Global Head of BIOS is a key position within the Global Clinical R&D and Clinical Operations organizations, responsible for the leadership and strategic direction of the global Biostatistics platform. He/she leads and oversees statistical and programming support for SP clinical portfolio to ensure that SP vaccine projects are optimally strategized, efficiently designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions, and the maintenance and growth of existing products. The incumbent represents BIOS organizationally within senior management and the corporate environment, enable successful impact on clinical development strategies and drive Quantitative vaccine development decision making, through effective partnership with senior leaders in Clinical Operations, Clinical Development, Translational Medicines, R&D and CMO.

Key Accountabilities:

Lead and oversee statistical and programming support for SP clinical portfolio to ensure that SP vaccine projects are optimally strategized, efficiently designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions, and the maintenance and growth of existing products.

  • Oversee directly or through subordinates the statistical work performed by the team.

  • Accountable directly or through subordinates for the statistical strategy and design in all projects for full compound development and product life cycle, the development of global platform trial delivery strategy and successful implementation.

  • Provide input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts, and manuscripts to ensure that statistical elements are in line with the overall product strategy.

  • Ensure incorporation of cost, time, risk/opportunity, benefit to subjects and probability of success into statistical design and analysis.

  • Permanent member of CRSF.

  • Contribute to decision making supporting and driving vaccine development milestone transitions, regulatory approvable dossiers, and life-cycle management of products.

  • Serves as a senior Statistical reviewer for submission documents.

  • Responsible for biostatistical components of submissions to regulatory agencies; represents the company when defending and/ or explaining statistical content of Sanofi Pasteur dossiers to regulatory agencies.

  • Effectively translates strategies into executable objectives.

Represent BIOS platform with senior management, internal stakeholders and external KoLs, to promote quantitative leadership in vaccine development and capitalize on opportunities to make statistical contribution.

  • Represent BIOS organizationally within senior management and the corporate environment .

  • Identify key stakeholders within organization and promote collaboration and optimal interaction (i.e. Clinical Development, Regulatory Affairs, Epidemiology, Global Medical Affairs, etc.).

  • Enable successful impact on clinical development strategies and drive quantitative vaccine development decision making, through effective partnership with senior leaders in Clinical Operations, Clinical Development, Translational Medicines, R&D and CMO.

  • Actively contribute to the strategic direction of the Clinical Operations, as a member of the COLT.

  • Cross-functional, transversal efforts in ClinOps, Clinical Department and R&D organization.

  • Drive collaboration with key internal quantitative partners (Translational, GCI Statistics, Epidemiology, Pharmaco-epidemiology, etc.) to leverage and optimize statistical excellence.

  • Actively collaborate with Sanofi biostatistics teams across the organization, promote implementation of joint processes and tools, and identify opportunities for improved inter-efficiency and leveraged statistical talent pool.

  • Establish and leverages a network of external collaborators, in statistical, clinical trial and vaccine areas, and across industry, academia and regulatory agency.

  • Stay abreast of latest developments in the fields of statistics and clinical trials, while rely on Statistical Innovation for technical details.

  • Oversee external collaborations with academic organizations: e.g., Fred-Hutchinson.

Drive the development/maintenance/implementation of optimal department standards (processes) and outsourcing strategy to increase productivity and quality, while decreasing cycle times and costs.

  • With Head of BRIC and other BIOS leaders, develop and implement an outsourcing strategy for the global platform in alignment with corporate Procurement and Sanofi Biostatistics.

  • With Head of BRIC and other BIOS leaders, develop and propose for budget and resource allocation to support the priorities of the R&D strategy.

  • Plan statistical resources to deliver on project objectives.

  • Contribute to the development of innovative processes and adoption of technologies that ensure the delivery of high quality and timely statistical analyses and data reporting.

  • Establish standards and ensure compliance to provide a framework to enable statistical consistency of data analyze.

  • Continuous improvement to ensure best practices and sound statistical applications.

  • Provide consistent, timely and accurate reports on operational components of ICH-GCP compliance, quality initiatives and regulatory considerations for Clinical Operations.

Responsible for the leadership and strategic direction of the global BIOS platform, to establish a high performing, industry recognized Biostatistics/Programming organization.

  • Develop and communicate vision/mission of the BIOS platform, drive the development & execution of strategic plans to achieve goals, and is accountable for their implementation.

  • With BIOS leaders, provide strategic direction to BIOS including plans to address evolving R&D strategy (Translational, Big Data, etc.) and strategic acquisition of critical skillsets.

  • Identify and evaluate BIOS opportunities that will shape the long-term future of the BIOS function: e.g., Translational.

  • Define priorities for the platform, e.g. methodology focus, healthcare data strategy, collaboration with key and/or new stakeholders, and innovation, and allocate resources according to the priorities.

  • Communicate strategic vision of the company/RD/Clinical department to global Biostatistics team.

  • Monitor team’s performance and progress against the R&D strategy and adjust accordingly.

Lead, direct and manage directly or through BIOS leaders the internationally-based team of biostatisticians and programmers in the BIOS platform.

  • Recruit and retain high quality staff to ensure a strong pipeline of talent.

  • Coach and develop direct reports.

  • Ensure global platform alignment with other global platform managers and Clinical team leaders regarding trial priorities, strategy and tactics.

  • Establish and steer a business founded on innovation, collaboration, high performance and trust and maintain targeted recruitment strategy for key strategic positions.

  • Team development and progression.

  • Instill and encourage an atmosphere of new ideas and thoughts within the Biostatistics team environment.

  • Focus on overall development of team’s skills that support corporate goals and objectives.

  • Reinforces the BIOS vision to leadership and scientific/strategic development by providing training and experiential opportunities, and continuous coaching and feedback.

Context of the job/major challenges:

The Global Head of the BIOS platform is responsible for the leadership and strategic direction of the global BIOS platform, to establish a high performing, industry recognized Biostatistics/Programming organization. The incumbent leads and oversees statistical and programming support for SP clinical portfolio to ensure that SP vaccine projects are optimally strategized, efficiently designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions, and the maintenance and growth of existing products. He/she will represent BIOS organizationally within senior management and the corporate environment, enable successful impact on clinical development strategies and drive Quantitative vaccine development decision making, through effective partnership with senior leaders in Clinical Operations, Clinical Development, Translational Medicines, R&D and CMO. The Global Head will establish and leverage a network of external key opinion leaders and collaborators in statistical, clinical trial and vaccine areas, and across industry, academia and regulatory agency. The incumbent will drive the development/maintenance/implementation of optimal department standards (processes) and outsourcing strategy to increase productivity and quality, while decreasing cycle times and costs. As the leader of the platform, he/she will establish and steer a business founded on innovation, collaboration, high performance and trust, recruit and retain high quality staff to ensure a strong pipeline of talent, and coach and develop reports.

Dimensions/Scope:

As the Global Head of BIOS, the incumbent’s financial budgetary responsibility is 3-4M Euros (including salaries, bonus and travel). The BIOS organization has 30-40 permanent staff in US and FR.

Education/E xperience:

M.S. in Statistics, Biostatistics, Mathematics or related discipline is required; Ph.D. is preferred. The Global Head is an influential leader with a strong understanding of product development process, substantial experience in scientific and Regulatory activities, with well-established track record for strong scientific and organizational leadership.

Required experience:

  • Minimum of 10 years biostatistics experience in industry.

  • Global biostatistics experience.

  • History of strong global team management.

  • Verbal and written proficiency in English.

  • Infectious diseases, vaccines or immunology experience is a strong plus.

  • Strong record of publications, research, presentations with credible network highly desired.

  • History of success in industry as a biostatistics expert.

  • Record of implementing new and successful ideas into international team strongly preferred.

  • Proven history in working on internationally dynamic and comprised teams.

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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