Sanofi Group Senior Director, Oncology Early Development Biostatistics, Cambridge, MA in Cambridge, Massachusetts
The immuno-oncology field is a highly dynamic space, where opportunity exists to uncover the solutions that will address the continuing unmet need of cancer patients. Sanofi’s goal is to develop the next generation of immune therapies by "leap-frogging" existing immunotherapy science with therapeutic combinations that represent the next wave of immuno-oncology treatments.
Sanofi’s oncology R&D division is committed to matching the right patient population with effective cancer therapies. This principle is a central theme at every stage of our pipeline starting from early discovery projects.
Provide leadership and guidance as a group manager and a statistical expert to a statistical group within oncology therapeutic area (TA). Be accountable for all statistical aspects of the projects within the group. Develop and promote state-of-the-art statistical methodology to optimize oncology early clinical development. Responsible for facilitating career development of direct reports.
Oncology early Development Biostatistics: Develop and promote state-of-the-art statistical methodology in the global oncology TA to optimize early clinical development, including translational medicine: identify innovative approach of interest for the oncology early development portfolio, collaborate with leadership in other departments to ensure statistical representation in key project decisions and regulatory meetings. Serve as departmental representative on division or corporate-wide teams.
Leading projects --- Direct statistical support and provide scientific leadership for one or more projects of clinical development. Ensure project teams have high quality statistical support for creation of clinical development plans (CDP), study design, analyses and operational aspects. Design and execution of CDPs consistently meeting internal guidelines and regulatory requirements. Maintain awareness of industry standards and regulatory requirements and novel methodologies/technologies.
Process management --- Oversee process for statistical reporting. Review critical documents, such as Statistical Analysis Plan (SAP), Key Results, Clinical Study Report (CSR), and integrated summaries. Ensure compliance with data submission guidelines. Summary documents adequately address major project objectives and are consistently delivered on time. Data consistently meets regulatory review needs. Decisions that can be supported from a statistical perspective and prospective regulatory agreements.
Managing people --- Manage the performance and career development of subordinates. Inspire and motivate team. Takes stand on important issues in productive, respectful way. Promote teamwork, quality, and innovation. Create productive work environment. Ensure staff compliance with SOPs and departmental standards.
Resource planning and efficiency --- Oversee resources needs for the team's responsibility. Seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas. Capacity to respond to unscheduled increase in team workload.
Requirements & Qualifications
PH.D. (MS) in statistics or related discipline with 8+ (10+) years of pharmaceutical experience, including significant interaction with both FDA and EMEA and successful project track records
Significant experience in oncology clinical development
Broad knowledge and superior understanding of advanced statistical concepts and techniques
Outstanding ability to effectively influence and to contribute to the advancement of innovative statistical methodology
Direct people management experience preferred, but indirect people management as project leader can be surrogate
Excellent verbal, writing, and presentation skills
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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