Sanofi Group Associate Director, HEOR Analyst in Bridgewater, New Jersey
Associate Director, HEOR Analyst
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Serve as project lead for designated therapeutic areas within Global Health Economics and Outcome Research to conduct post-hoc analysis of randomized clinical trials and network meta-analysis / indirect treatment comparison in support of market access and reimbursement evidence needs
Develop or review study protocols / statistical analysis plans and conduct analysis through programming expertise for HEOR 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 Value & Access and HEOR Evidence Leads to develop the evidence generation plan with rigorous methodology and ensure timely execution to meet evidence needs for market access and reimbursement
Design and conduct analysis for networkmeta-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 both within global HEOR and with cross-functional teams such as Value & Access, Clinical Development, Biostatistics, Medical Affairs and affiliates.
Draft or review analytic results for all reportsand 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
Basic 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 / analyst supporting clinical trials, HEOR studies, medical affairs or clinical development
Fluent with statistical programming packages, such as SAS and R, 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
Excellent communication skills, both written and oral
In-depth understanding of methodological issues inclinical trials, meta-analysis, and data mining
Ability to communicate effectively the methods andresults of complex analyses to a wide range of audience
Ability to function autonomously and manage thedelivery of projects with quality control
Expertise with standard programming packages, fullproficiency with MS Office
Ability to work effectively in a team environment
Excellent project management skills and ability tomeet deadlines
Flexibility to adapt to diverse clients andproject needs
Demonstrated records of publication activities
Job: Market Access
Primary Location: United States-New Jersey-Bridgewater
Job Posting: Oct 7, 2016, 3:38:28 PM
Job Type: Regular
Employee Status: Regular