Manager, Biostatistics – Patient Reported Outcomes (PRO)

Role Overview

• 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.

Tech Stack

• Python

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!