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!

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

statistical analysisstatistical methodsdata interpretationadvanced statistical methodologyrandomized studiesobservational studiesreal-world studiesSASRPython

Soft Skills

teamworkinnovationmotivationresource planningcoordination

Certifications

PhD in statisticsDrPH in biostatisticsMS in statistics