Serve as project lead for designated therapeutic areas within Real World Evidence & Clinical Outcomes (RWE&CO) to conduct post-hoc analysis of randomized clinical trials and network meta-analysis / indirect treatment comparison in support of medical affairs, market access or reimbursement evidence needs
Develop or review study protocols / statistical analysis plans and conduct analysis through programming expertise for RWE&CO studies; ensure the highest standards of excellence are applied to these studies from scientific perspective and in full compliance with Sanofi SOPs and requirements from health authorities
Identify, select vendors and manage deliveries in collaboration with internal stakeholders
Interpret, communicate the findings to internal audience and publish externally in scientific congress, peer-reviewed journals
Consult with Medical Affairs, Health Economics, Value & Access (HEVA), and Real World Evidence Investigators to develop the evidence generation plan with rigorous methodology and ensure timely execution to meet evidence needs
Design and conduct analysis for network meta-analysis, post-hoc analysis of randomized clinical trials and data mining, ensure compliance with best scientific practices and create study reports
Provide statistical expertise to effectively communicate the evidence generation plan and findings within cross-functional teams including Medical Affairs, HEVA, Clinical Development, Biostatistics, and local affiliates.
Draft or review analytic results for all reports and publications
Ensure validation as per SOP of secondary data analysis protocol
Create statistical sections for study synopses, protocols, or scientific publications
Develop or review statistical inputs and results in submitted materials to external stakeholders, including scientific congress, peer-reviewed journals, regulatory/HTA submissions, core value dossiers etc.
Advise on the methodological decisions and their efficiency to support findings from HEOR studies
Analyze, manage and optimize related databases
Guide junior team members to execute the analysis and review the results for finalization
Use and develop statistical analysis programs to execute complex modeling and data mining projects
Maintain documentation for data, programs, and results
Manage external vendors for the delivery of study protocol, statistical outputs and study reports
Defend statistical positions in interaction with other internal functions or external stakeholders
Qualifications & Experience
MSc or PhD in Statistics, Biostatistics or related quantitative sciences with demonstrated record of complex modeling
Minimum 5 years working experience as a statistician supporting clinical trials, RWE or HEOR studies, medical affairs or clinical development
Experience with mathematical/statistical programming packages, such as SAS, SQL, Stata, R, Python, experience with OpenBUGS and Bayesian framework a plus
Demonstrated ability to adapt to different programming frameworks and operating platforms
Previous experience with submissions to regulatory and/or core value dossier development
Good knowledge of technical guidelines (e.g. NICE DSU)
Skills & Competencies
Excellent communication skills in English, both written and oral
In-depth understanding of methodological issues in clinical trials, meta-analysis, and data mining
Ability to communicate effectively the methods and results of complex analyses to a wide range of audience
Ability to function autonomously and manage the delivery of projects with quality control
Expertise with standard programming packages, full proficiency with MS Office
Ability to work effectively in a team environment
Excellent project management skills and ability to meet deadlines
Flexibility to adapt to diverse clients and project needs
Demonstrated records of publication activities
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