Sanofi Group Associate Director, Biostatistics (Rare Diseases) in Cambridge, Massachusetts

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

Genzyme Corporation (a Sanofi company) 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.

Job Responsibilities:

The Associate Director of Biostatistics (Rare Diseases) will be a key member of several teams responsible for 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 (Cerdelga, Myozyme, Fabrazyme, Cerezyme, Aldurazyme, Caprelsa) and the analyses will be mostly post-hoc and oriented toward the needs of rare Diseases disease area-related conferences, health care provider and payer audiences. The AD Biostatistics will provide input to cross-functional groups led by Medical Affairs who brainstorm, select, and prioritize new post-hoc analyses to meet specific strategic goals, and to groups who develop the abstracts and manuscripts. The incumbent will furthermore be 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 hands-on role. Statistical approaches and methods will require innovative and customized approaches. The AD, Biostatistics would also "own" 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.

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 and support publishing of critical data about multiple diseases and available effective therapies for the treatment of Rare Diseases.

Major Duties and Responsibilities:

  • 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

  • Design, conduct, QC and report on agreed upon analyses. This includes developing analysis specifications/plans, performing hands-on statistical programming and/or supervising external contractors doing such 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.

  • 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, colleagues in affiliate countries around the world, external medical writers, alliance partners, 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.

  • Review draft presentations and training materials, including posters and slide decks, according to deadlines.

  • Assist the Senior Director 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 Health Economics and Value Assessments 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). Hands-on Programming experience.

  • Excellent interpersonal skills, negotiation skills, and verbal and written communications

  • 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.

Qualifications :

  • PhD in Biostatistics or Statistics and 7 years of experience designing and conducting statistical analyses based on experimental data from in vitro, animal and/or human studies, including 5 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 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)

Preferred Qualifications:

  • 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 Rare Diseases clinical trials and observational studies a plus

  • Experience publishing results

  • Experience working with external service providers, including project management, vendor management and budget process

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.