Register
Recruit Create CV
Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Related keywords
Some similar recruitments
Non-Clinical Process Cmc Principal Statistician - Vaccine
Recruited by Sanofi 1 year ago Address Waltham, MA, United States
Survey Data Analyst Jobs
Recruited by CDC Foundation 1 year ago Address Massachusetts, United States

Post-Hoc Statistician Jobs

Company

Sanofi
Address Cambridge, MA, United States
Employment type FULL_TIME
Salary
Category Chemical Manufacturing,Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-07-29
Posted at 10 months ago
Job Description
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
  • Thorough and up-to-date working knowledge of SAS with hands-on programming experience. Knowledge of S-PLUS or R is a plus
  • Ability to negotiate and advocate with strong methodological arguments with the partners to improve quality of the deliverables and interpretation
  • Working knowledge of PROs; experience in psychometric evaluation is a plus
  • 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
  • Ability to explain strategies, approaches, methods, analyses, and findings to non-statisticians; ability to help others interpret results and place in context
  • Thorough and up-to-date knowledge of statistical methods, especially those related to human clinical studies
  • Present and explain statistical analyses to team members, internal forum, internal managers and/or external authors and experts
  • Ability to manage projects, to quickly accommodate changing priorities and to meet tight deadlines while maintaining high quality standards
  • MSc or PhD in Statistics, Biostatistics or related quantitative sciences
  • Knowledge of HTA technical guidelines (ie. NICE DSU, IQWiG General Methods) is a plus
  • 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)
  • Psychometric assessment of COAs: Review psychometric analysis plans and reports, and serve as key statistical contact for the vendor in charge of the analyses
  • 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
  • Competencies in written & spoken English
  • Working knowledge of SDTM and ADaM data structure and CDISC standards
  • Experience working with external service providers
  • 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
  • Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices (ie. CTD guidance, ICH guidelines)
  • Lead, design, conduct and QC post-hoc statistical analyses required for HTA submissions and pricing/reimbursement negotiations:
  • 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
  • Demonstrated leadership, project management, and interpersonal and negotiation skills, with excellent verbal and written communication skills
  • Experience publishing results, including writing of abstracts and manuscripts
  • Collaborative approach; ability to thrive in a fast-paced team environment and to work independently on projects
  • Understanding of other functional areas as well as transversal groups and ability to maintain productive inter-function working relationships