Manager, Biostatistics - Patient Reported Outcomes (PRO)

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.

This role might be for you if you can/have: ​

• 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.

To be considered for this opportunity, you must have the following:

• 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.

#GDBDMJobs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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! For additional information about Regeneron benefits in the US, please visit For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)