Sanofi Group Director, Biostatistics Immunology- Cambridge,MA in Cambridge, Massachusetts
Director, Biostatistics (Immunology)
Global Scientific Communication, Global Medical Affairs
At Sanofi Genzyme we are committed to the growth of our people, connected in purpose by career, life and health. Headquartered in Cambridge, MA Sanofi Genzyme is part of a leading global healthcare company that is dedicated to improving health and driving back disease by making innovative medicines accessible to people around the world. Our extensive research and development efforts encompass a wide range indications including: Rare Diseases, Rare Blood Disorders, Oncology, Multiple Sclerosis and Immunology.
Sanofi Genzyme is an equal opportunity employer that embraces diversity to foster positive, innovative thinking that will benefit people worldwide. Sanofi Genzyme is also committed to employing qualified individuals with disabilities and, where warranted, will provide reasonable accommodation to applicants, as well as its employees.
Job Responsibilities/Department Description:
The Director of Biostatistics (Immunology) 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 Genzyme-sponsored clinical studies, including Phase 3 and 4 studies and exploratory analyses. This position supports Global Medical Affairs and in-market products (Sarilumab and Dupilumab) and the analyses will be mostly exploratory/post-hoc and oriented toward the needs of Immunology disease area-related conferences, health care provider and payer audiences. The Director of Biostatistics 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 incumbent 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 incumbent will furthermore 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 — this is a leadership and hands-on role. Statistical approaches and methods will require innovative and customized approaches. The Director of Biostatistics would also be responsible for the tracking documents and file archives for analysis plans, programming code, output, and associated reports. They will collaborate closely with internal statistics leaders and cross functional teams, as well as with our alliance partner companies, as relevant, and when necessary, oversee the work of external biostatistics and programming contractors. As strong partnership across several stakeholders is key to the success of this role, it is important to have very good communication skills and be fully comfortable in working with colleagues who are not co-located.
This is an exciting opportunity to be part of an active, high profile, high-impact Medical Affairs Department, to perform interesting and complex statistical analyses in support of key product launches.
Major Duties and Responsibilities will include, but are not limited to, the following:
Understand 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. This covers leadership across all activities including developing analysis specifications/plans, performing hands-on statistical programming and/or supervising external contractors responsible for analysis and programming. Analyses might be pre-planned or post-hoc, hypothesis testing or hypothesis generating, intended for dissemination or exploratory. Present and/or explain findings to team members, internal managers, and/or external authors and experts. Validate inferences. Help craft listings and tables needed for abstracts, posters, slide decks, and manuscripts.
Co-leading forums/meetings /JDAC team when the focus is on analytical/data concepts and support the brainstorming and prioritization of the required post-hoc analysis. A critical need is to bring in disease area expertise and knowledge to these discussions.
Influence, input and contribute significantly to the strategic planning for brand plans associated with medical and scientific communications, aligning with the strategic imperatives
Provide consultation, input and guidance to cross-functional groups charged with development and submission of manuscripts, posters, slide presentations and abstracts.
Provide consultation, input and guidance to cross-functional groups charged with exploratory analyses and lifecycle management projects/studies.
Establish and maintain collegial and collaborative relationships with cross-functional group members, Medical Affairs leaders, alliance partners, colleagues in affiliate countries around the world, external medical writers, and external experts and authors.
Work with Publication Leads and team members to respond in a timely manner to journal editor and reviewer comments.
Review draft abstracts and manuscripts according to deadlines, and when appropriate, serve as an author. In some cases, develop abstracts in close collaboration with external medical writers. Serve as group's expert on methods sections.
As needed, support statistical analysis needs for dossier and/or response document submissions to HTA/payer bodies and independent therapeutic reviews (i.e. ICER) and analyses required by payers.
Depending on resource needs, assign tasks and supervise the work of external contract statisticians and programmers, as well as internal resources.
Review draft presentations and training materials, including posters and slide decks, according to deadlines.
Assist the Head of Biostatistics when requested in any of his/her job responsibilities.
As needed, provide consultant-level support in developing Statistical Analysis Plans (SAPs)/stats sections of Phase 4 protocols (including performing sample size calculations), and supporting feasibility determinations for Phase 4 and HEOR studies, upon request. Consult regarding primary and secondary endpoints as per medical strategy. Upon request, review protocols and SAPs from Investigator-sponsored Studies.
As needed, perform all activities listed above, in collaboration with external co-development/commercialization alliance partner companies.
Maintain expertise in current statistical methods and standards relevant to pharma and biotech industry applications.
Knowledge and Skills:
Thorough and up-to-date knowledge of statistical methods, especially those related to human clinical studies, including composite endpoints, time-to-event and recurrent event analysis, binary, count and categorical data analysis, longitudinal data analysis (e.g. LME, GEE), missing data methods, nonparametric methods, ANCOVA, responder and treatment failure analyses, data-mining techniques, meta-analysis, etc.
Thorough and up-to-date working knowledge of SAS and S-PLUS (or R), and CDISC standards. Hands-on Programming experience.
Demonstrated leadership, project management, and interpersonal and negotiation skill, with excellent verbal and written communications
Excellent relevant disease area knowledge working directly on clinical trial protocols and data reporting in industry setting.
Collaborative approach. Ability to thrive in a fast-paced team environment, and also work independently on projects.
Ability to manage effectively one's projects and quickly accommodate to changing priorities, and also to meet tight deadlines while maintaining high quality standards
Ability to explain strategies, approaches, methods, analyses, and findings to non-statistician group members and senior managers. Ability to help others interpret results and place in context.
PhD in Biostatistics or Statistics and at least 8-10 years of experience designing and conducting statistical analyses based on experimental data from in vitro, animal and/or human studies, including 8 years of experience designing and conducting statistical analyses from human Phase 3 and/or 4 clinical trial data, both pre-planned and post-hoc, in an industry setting (e.g., pharma, biotech, CRO) OR
Master's degree in Biostatistics or Statistics and at least 12-14 years of experience designing and conducting statistical analyses based on experimental data from in vitro, animal and/or human studies, including 12 years of experience designing and conducting statistical analyses from human Phase 3 and/or 4 clinical trial data, both pre-planned and post-hoc, in an industry setting (e.g., pharma, biotech, CRO)
Experience in medical affairs activities
Experience in reporting data on multiple long term extension studies
Specific knowledge and experience in analysis plans and techniques to support approved products in competitive markets
Experience analyzing data from Immunology (RA, Dermatology, etc) studies
Experience publishing results
Experience working with external service providers, including project management, vendor management and budget process
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
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