The Biostatistics Project Leader is responsible for providing the statistical expertise for assigned products or programs, including response to statistical issues arising in regulatory, commercial, worldwide medical or other legal settings, and may include addressing issues from external development partners and internal cross-functional project teams. He/She builds and maintains strong collaboration with different disciplines across the organization in order to identify and meet their needs for statistical support. He/She also contributes to the long-term growth strategy of the department. He/She ensures that standard procedures are followed within projects. Provides statistical leadership in cross-functional project teams to develop statistical strategies and deliver statistical solutions.
Represents Biostatistics on study and/or project teams as required, and provides professional statistical support to clinical development teams.
Able to make decisions at CDT level across a variety of studies with minimal input from line or project manager.
Able to handle requests from regulatory agencies, health authorities, across multiple drug programs, often under tight timelines.
May lead organization wide initiatives e.g. Process, Quality, standardization etc.
Contributes to hiring/development of Biostatistics function and Biometrics department members as required
Interacts with team members across functional areas and multiple studies
Leads and supports staff to resolve statistical or technical issues.
Accountable for resource allocation, requirement estimation, prioritization and timeline management within assigned projects.
MS or PhD in Biostatistics/Statistics and equivalent
MS in Biostatistics/Statistics with a minimum of 6 years relevant experience or PhD in Biostatistics/Statistics or equivalent with a minimum of 4 years relevant work experience
Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.
Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.
Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
Conversant with SAS programming, and detailed knowledge of SAS procedures and other statistical software.
Knowledge of the clinical development process and the role of biostatistics.
Broad knowledge of medical/biological terminology and clinical trial designs and competitive landscape in relevant therapeutic areas.
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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