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About the role
- Manager of Biostatistics for Patient Reported Outcomes at Regeneron. Supporting analysis and collaborations with cross-functional teams and external partners.
Responsibilities
- Support the analysis of PRO data ensuring methodological rigor, and regulatory adherence.
- Create and refine statistical analysis plans, conduct complex statistical analyses and convey findings to internal and external stakeholders.
- Apply fit for purpose statistical methods tailored to specific study objectives, ensuring robust data interpretation and insight generation.
- Develop working knowledge of Regeneron asset(s) and support efforts to apply appropriate tools within therapeutic areas.
- Strong understanding of data sources and leverage hands on data review to guide the selection of appropriate techniques and methods.
- Authoring of technical documents including statistical analyses plans, programming specifications and TFL mock shells.
- Support statistical efforts for assigned projects, manage timelines, resources, and coordinate across departments and external stakeholders.
- Stay informed on industry trends, incorporate emerging biostatistical methods to enhance analysis and participate in methodological research for the development of analytical techniques.
- Assist preparation for biostatistical support on PRO analysis during regulatory interactions, and provide statistical efforts to address queries to ensure alignment with regulatory standards for organizational decision-making processes.
- Stay informed with guidance documents from regulators to industry on use of PROs for regulatory decision making.
Requirements
- PhD / DrPH in statistics/biostatistics or related disciplines with >2 years experience in the pharmaceutical/biotech industry or MS degree in statistics/biostatistics with >7 years’ experience in the pharmaceutical industry or academic organization as a statistician
- Knowledge of current statistical methods, at least 2 years using SAS/R/Python to solve statistical problems
- Strong knowledge in advanced statistical methodology to support different endpoints common to PROs
- Strong knowledge with analysis using the clinical database for scientific meetings, publications, and internal decision-making
- Strong knowledge in statistical methods to support Health Economics and Outcomes Research including patient reported outcomes (including development/validation), HTA/reimbursement/value dossiers, and real-world studies
- Experience in statistical methods to support new studies including randomized studies, observational (non-randomized) studies, registries, non-interventional studies, cluster randomization, pragmatic clinical trials, etc.
- Experience promoting teamwork, innovation, and motivation.
- Experience estimating and planning resource needs and allocation.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave) for eligible employees at all levels!
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