Sanofi
Biostatistics Lead - Oncology and Rare Blood Disorders
Sanofi, Cambridge, Massachusetts, us, 02140
Biostatistics Lead - Oncology and Rare Blood Disorders
Job DescriptionL3-2About the JobWe are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.Our TeamThe Medical Excellence Team is part of Medical Operations & Effectiveness within Sanofi Specialty Care. Medical Excellence partners with our global therapeutic area medical teams, our country level teams, and other functions across Sanofi Specialty care to provide solutions that inform strategy, optimize scientific engagement, build competencies across the medical team with the ultimate goal of enhancing the impact the medical team has for patients.The
Biostatistics Lead
will be a key member of several teams responsible for leading the development and conduct of statistical analyses contributing to the submission of publications and presentations arising from Sanofi Specialty Care sponsored clinical studies, including Phase 3 and 4 studies, and exploratory analyses.This position supports Global Medical Affairs and marketed products, and analyses will be mostly exploratory/post-hoc and oriented toward the needs of therapeutic area-related conferences, and health care provider and payer audiences. The Biostatistics Lead will provide strategic input to cross-functional teams led by Medical Affairs who develop, select, and prioritize new exploratory/post-hoc analyses to meet specific strategic goals, and to teams who develop the abstracts and manuscripts.The ideal candidate will come with relevant disease area expertise to be able to contribute significantly to the strategic planning for brand plans associated with medical and scientific communications. The successful candidate will be fully accountable for performing, QC'ing, and fine-tuning the chosen analyses, plus explaining and interpreting findings for internal colleagues, management, and external authors. The Biostatistics Lead will also be responsible for tracking documents and file archives for analysis plans, programming code, output, and associated reports.Statistical approaches and methods will require innovative and customized approaches. The Biostatistics Lead will collaborate closely with internal statistics leaders and cross-functional teams, as well as with alliance partner companies, as relevant, and the work of internal biostatistics and programming resources. As strong partnership across several stakeholders is key to the success of this role, it is important to have excellent communication skills and be fully comfortable in working with colleagues who are not co-located.This is a leadership and hands-on role and this is an exciting opportunity to be part of an active, high-profile, high-impact Medical Affairs Department, and to perform interesting and complex statistical analyses in support of key product launches.Job ResponsibilitiesUnderstand existing studies, datasets, and analyses well enough to inform team members and guide strategy for future analyses. Harmonize statistical strategies and methods across departments.Lead, design, conduct, QC, and report on agreed upon analyses, including innovative and complex methods, for multiple products and therapeutic areas.Co-lead forums and meetings focused on analytical/data concepts, and support brainstorming and prioritization of required post-hoc analysis.Influence and contribute significantly to the strategic planning for brand plans associated with medical and scientific communications.Provide consultation, input, and guidance to cross-functional groups charged with development and submission of manuscripts, posters, slide presentations, and abstracts.Establish and maintain collegial and collaborative relationships with cross-functional group members, Medical Affairs leaders, alliance partners, and external experts.Assign tasks and supervise the work of internal statistical and programming resources.Maintain expertise in current statistical methods and standards relevant to pharma and biotech industry applications.Attend scientific congresses to provide statistical support for presentations.Knowledge and SkillsThorough and up-to-date knowledge of statistical methods related to human clinical studies.Demonstrated leadership, project management, and interpersonal skills, with excellent verbal and written communication skills.Collaborative approach with the ability to thrive in a fast-paced team environment.Basic QualificationsPhD in Biostatistics or Statistics (or similar) and at least 8 years of experience designing and/or conducting statistical analyses based on human studies.Master's degree in Biostatistics or Statistics (or similar) and at least 12 years of experience designing and/or conducting statistical analyses based on human studies.Preferred QualificationsExperience in medical affairs activities.Experience in reporting data on multiple long-term extension studies.Experience analyzing data from Oncology and Rare Blood Disorder studies.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.
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Job DescriptionL3-2About the JobWe are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.Our TeamThe Medical Excellence Team is part of Medical Operations & Effectiveness within Sanofi Specialty Care. Medical Excellence partners with our global therapeutic area medical teams, our country level teams, and other functions across Sanofi Specialty care to provide solutions that inform strategy, optimize scientific engagement, build competencies across the medical team with the ultimate goal of enhancing the impact the medical team has for patients.The
Biostatistics Lead
will be a key member of several teams responsible for leading the development and conduct of statistical analyses contributing to the submission of publications and presentations arising from Sanofi Specialty Care sponsored clinical studies, including Phase 3 and 4 studies, and exploratory analyses.This position supports Global Medical Affairs and marketed products, and analyses will be mostly exploratory/post-hoc and oriented toward the needs of therapeutic area-related conferences, and health care provider and payer audiences. The Biostatistics Lead will provide strategic input to cross-functional teams led by Medical Affairs who develop, select, and prioritize new exploratory/post-hoc analyses to meet specific strategic goals, and to teams who develop the abstracts and manuscripts.The ideal candidate will come with relevant disease area expertise to be able to contribute significantly to the strategic planning for brand plans associated with medical and scientific communications. The successful candidate will be fully accountable for performing, QC'ing, and fine-tuning the chosen analyses, plus explaining and interpreting findings for internal colleagues, management, and external authors. The Biostatistics Lead will also be responsible for tracking documents and file archives for analysis plans, programming code, output, and associated reports.Statistical approaches and methods will require innovative and customized approaches. The Biostatistics Lead will collaborate closely with internal statistics leaders and cross-functional teams, as well as with alliance partner companies, as relevant, and the work of internal biostatistics and programming resources. As strong partnership across several stakeholders is key to the success of this role, it is important to have excellent communication skills and be fully comfortable in working with colleagues who are not co-located.This is a leadership and hands-on role and this is an exciting opportunity to be part of an active, high-profile, high-impact Medical Affairs Department, and to perform interesting and complex statistical analyses in support of key product launches.Job ResponsibilitiesUnderstand existing studies, datasets, and analyses well enough to inform team members and guide strategy for future analyses. Harmonize statistical strategies and methods across departments.Lead, design, conduct, QC, and report on agreed upon analyses, including innovative and complex methods, for multiple products and therapeutic areas.Co-lead forums and meetings focused on analytical/data concepts, and support brainstorming and prioritization of required post-hoc analysis.Influence and contribute significantly to the strategic planning for brand plans associated with medical and scientific communications.Provide consultation, input, and guidance to cross-functional groups charged with development and submission of manuscripts, posters, slide presentations, and abstracts.Establish and maintain collegial and collaborative relationships with cross-functional group members, Medical Affairs leaders, alliance partners, and external experts.Assign tasks and supervise the work of internal statistical and programming resources.Maintain expertise in current statistical methods and standards relevant to pharma and biotech industry applications.Attend scientific congresses to provide statistical support for presentations.Knowledge and SkillsThorough and up-to-date knowledge of statistical methods related to human clinical studies.Demonstrated leadership, project management, and interpersonal skills, with excellent verbal and written communication skills.Collaborative approach with the ability to thrive in a fast-paced team environment.Basic QualificationsPhD in Biostatistics or Statistics (or similar) and at least 8 years of experience designing and/or conducting statistical analyses based on human studies.Master's degree in Biostatistics or Statistics (or similar) and at least 12 years of experience designing and/or conducting statistical analyses based on human studies.Preferred QualificationsExperience in medical affairs activities.Experience in reporting data on multiple long-term extension studies.Experience analyzing data from Oncology and Rare Blood Disorder studies.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.
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