Post-Hoc Statistician

Position Overview:

• Serve as Project Lead within Global HEVA and across multiple therapeutic areas to conduct post-hoc analysis of clinical trials in support of market access and reimbursement evidence needs

• Scientifically accountable at global and local levels for design and timely execution of post-hoc statistical analyses for HTA submissions and pricing/reimbursement negotiations

• Support countries for local HTA submissions

• Provide statistical expertise within HEVA and with several stakeholders including Market Access and Pricing, Medical Affairs, Clinical Outcome Assessment team, Biostatistics

Key Responsibilities

• Lead, design, conduct and QC post-hoc statistical analyses required for HTA submissions and pricing/reimbursement negotiations:

  • Global: efficacy in target populations; health-economic modeling (cost-effectiveness); indirect treatment comparisons; post-hoc evidence to support development of Payer Value Story and Objection Handler including analyses to support identification of high burden subgroups with high likelihood of reimbursement

  • Country: support country specific post-hoc requirements for health-economy modeling, and efficacy in target population and subgroups; work closely with country market access leads in coordination with Global teams; part of HTA Rapid Response team and responsible for ensuring timely completion of any requests from HTA bodies

• Present and explain statistical analyses to team members, internal forum, internal managers and/or external authors and experts

• Publication activities: Provide consultation, input and guidance to cross-functional groups charged with development and submission of manuscripts, posters, slide presentations and abstracts; work with Publication Leads and team members to respond in a timely manner to journal editor and reviewer comments

• Support clinical teams in the analyses of clinical outcome assessments (COAs), in particular patient-reported outcomes (PROs), and Health Economic endpoints for phase 2 to 4 studies, by contributing and/or reviewing protocols, statistical analysis plans, clinical study reports, and submission modules

• Psychometric assessment of COAs: Review psychometric analysis plans and reports, and serve as key statistical contact for the vendor in charge of the analyses

Basic Qualifications & Experience

• MSc or PhD in Statistics, Biostatistics or related quantitative sciences

• Minimum 8 years of experience as a statistician supporting clinical trials, medical affairs, or clinical development, including conducting statistical analyses from phase 3 or phase 4 studies, in an industry setting (ie. pharma, biotech, CRO)

Knowledge and Skills

• Thorough and up-to-date knowledge of statistical methods, especially those related to human clinical studies

• Thorough and up-to-date working knowledge of SAS with hands-on programming experience. Knowledge of S-PLUS or R is a plus

• Working knowledge of SDTM and ADaM data structure and CDISC standards

• Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices (ie. CTD guidance, ICH guidelines)

• Working knowledge of PROs; experience in psychometric evaluation is a plus

• Knowledge of HTA technical guidelines (ie. NICE DSU, IQWiG General Methods) is a plus

• Experience publishing results, including writing of abstracts and manuscripts

• Ability to manage projects, to quickly accommodate changing priorities and to meet tight deadlines while maintaining high quality standards

• 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 explain strategies, approaches, methods, analyses, and findings to non-statisticians; ability to help others interpret results and place in context

• Ability to negotiate and advocate with strong methodological arguments with the partners to improve quality of the deliverables and interpretation

• Understanding of other functional areas as well as transversal groups and ability to maintain productive inter-function working relationships

• Experience working with external service providers

• Competencies in written & spoken English

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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.

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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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