Sanofi Group Biostatistics Lead, Rare Diseases in Cambridge, Massachusetts
The Biostatistics Lead (Rare Diseases) 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-Genzyme-sponsored clinical studies, including Phase 3 and 4 studies, and exploratory analyses. This position supports Global Medical Affairs and marketed products, and the analyses will be mostly exploratory/post-hoc and oriented toward the needs of Rare Diseases (including, but not limited to, Pompe Disease, Gaucher Disease, and Fabry Disease) 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 contribute significantly to the strategic planning for brand plans associated with medical and scientific communications. The successful candidate 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 Biostatistics Lead 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 alliance partner companies, as relevant, and 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 excellent 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 Team, and to perform interesting and complex statistical analyses in support of key products
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 when needed, 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 in nature. 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-lead forums/meetings when the focus is on analytical/data concepts, and support brainstorming and prioritization of the required post-hoc analysis. A critical need is to bring in disease area expertise and knowledge to these discussions, although these can be assimilated on the job.
Influence 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 worldwide affiliate countries, external medical writers, 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 the Publication Team’s expert on statistical methods sections.
As needed, support statistical analysis needs for dossier and/or response document submissions to HTA/payer bodies and independent therapeutic reviews (e.g. ICER).
Assign tasks and supervise the work of external contract statisticians and programmers, as well as internal resources.
As needed, provide consultant-level support for feasibility determinations for HEOR/HEVA studies, and consult regarding primary and secondary endpoints.
Maintain expertise in current statistical methods and standards relevant to pharma and biotech industry applications.
Attend scientific congresses to provide statistical support for presentations and to gain insights of competitors’ statistical analyses.
Assist the Head of Biostatistics when requested in any of their job responsibilities.
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 skills, with excellent verbal and written communication skills.
Collaborative approach. Ability to thrive in a fast-paced team environment, and to work independently on projects.
Ability to manage one's projects and quickly accommodate to changing priorities, and to meet tight deadlines while maintaining high quality standards.
Ability to explain strategies, approaches, methods, analyses, and findings to non-statisticians. Ability to help others interpret results and place in context.
PhD in Biostatistics or Statistics or related discipline and 5+ years of post-Doctoral experience designing and conducting statistical analyses based on experimental data from in vitro, animal and/or human studies, including 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 or related discipline and 7+ years of post-Masters experience designing and conducting statistical analyses based on experimental data from in vitro, animal and/or human studies, including 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 with SDTM and ADaM data structure and CDISC standards.
Experience analyzing data from Rare Disease 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.