Manager, Biostatistics - Patient Reported Outcomes (PRO)

Regeneron Pharmaceuticals•Sleepy Hollow, WY

21d•Onsite

About The Position

Regeneron is seeking a Manager, Biostatistics - Patient Reported Outcomes (PRO) to join our team! The Manager of Biostatistics for Patient Reported Outcomes (PRO) analysis will support multiple programs across therapeutic areas and cultivate strong partnerships to enable effective cross-functional collaboration with other product team members from internal groups including BDM, Medical Affairs/HEOR, Clinical Development, Regulatory Affairs and other functions as needed. In addition, the Manager of Biostatistics for PRO analysis will support collaborations with external partners (e.g. CROs, industry consortiums, key opinion leaders). He/She will work with the Director of Biostatistics for PRO to drive and establish best practices with regards to PRO analyses. In this role, a typical day might include: 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 (generally based on previously conducted randomized clinical trials).
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.

Nice To Haves

Strong interest and motivation in exploring PRO data for post-hoc analysis and innovative idea investigations
Experience with designing clinical trials especially observational types of studies
Exposure to study endpoints and analysis techniques across multiple therapeutic areas
Strong communication skills to interpret, explain, and discuss results of complex statistical concepts and analyses to both technical and non-technical audiences.
Desire to present and share results with internal and external stakeholders.
Experience with providing scientific/statistical input into study design, formulating novel problem-solving methods and independently developing the statistical analysis plan to implement those solutions.
Experience of authoring Statistical Analysis Plans (SAP), PRO SAP and Protocols
Experience with innovative ways to generate tables, listings, and figures for external communication use in publications/presentations and for internal purposes.
Ability to translate and apply relevant innovative statistical methodology to everyday work.
Experience of educating and disseminating knowledge throughout the organization for areas within the expertise of medical affairs.

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.

Benefits

We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

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