Director, Biostatistics - Patient Reported Outcomes (PRO)

Regeneron Pharmaceuticals • Warren, MI

21d • Onsite

About The Position

Regeneron is seeking a Director, Patient Reported Outcomes to join our Biostatistics organization! In this role, a typical day might include: The Director of Biostatistics for Patient Reported Outcomes (PRO) analysis is a leadership role within BDM-Biostatistics team who will support multiple programs across therapeutic areas and cultivate strong partnerships between Clinical Development Biostatistics and Medical Affairs Biostatistics team, to enable effective cross-functional collaboration with team members from internal groups including BDM, Medical Affairs/ HEOR, Clinical Development, Regulatory Affairs, Market Access/Regional Affiliates and other functions as needed. In addition, the director of biostatistics for PRO analysis will support collaborations with external partners (e.g. CROs, industry consortiums, key opinion leaders, HTA authorities), serving as a subject matter expert (SME) on PRO analysis within Regeneron to drive and establish best practices with regards to PRO analyses and modeling, results interpretation and communications. This position requires onsite presence based in Sleepy Hollow campus (preferred location) or Tarrytown/Warren campus with regular Sleepy Hollow campus visits. This role might be for you if you can/have: Biostatistical and Methodological Support Lead and oversee the end to end process of PRO support from data collection to data analysis within BDM in collaboration with HEOR team ensuring statistical rigor and appropriateness, and regulatory adherence and HTA requirement fulfillment. Create, develop and refine PRO statistical analysis plans (PRO SAP), contribute to PRO analysis section in the protocol and clinical study SAP when applicable, authoring technical documents, including statistical analyses plans, programming specifications and TFL mock shells. Establish and guide modeling expertise in various PRO instruments under different trial designs, conduct appropriate 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, as well as scientific communication of the results Must be able to work collaboratively with statistical programming and provide detailed and timely guidance towards the planned analyses, when external support is needed, oversee vendor selection, contract, budget and project management Represent PRO SME at BDM-Biostatistics ELT team Therapy Area Knowledge Develop working knowledge of Regeneron asset(s) and the PRO endpoints needed as part of the overall evidence generation efforts; act as a senior level consultant to select PRO endpoints and apply appropriate tools within therapeutic areas. Excellent knowledge on the PRO endpoints and strong understanding of data sources and leverage hands on data review to guide the selection of appropriate PRO endpoints, techniques and methods. Solid knowledge on general Clinical Outcome Assessment (COAs) related aspects and up-to-date knowledge on regulatory updates on COAs Project Management and Staff Mentorship Manage the PRO team with both full time employees and temp workers; mentor junior staff, guiding and developing their capabilities through mentorship, training, and professional growth opportunities while promoting knowledge sharing, continuous learning, and an innovative and collaborative environment. Serve as the primary contact for PRO analysis for HEOR team and lead statistical efforts on PRO with BDM, manage timelines, resources, budget, contracts, vendors, and coordinate across departments and external stakeholders In terms of external vendor involvement, serve as the primary Regeneron contact for vendor selection, contract, budget and project management Statistical Innovation, Continuous Education and Initiative Stay informed on industry and academic trends on PRO endpoints and analysis, incorporate innovative emerging biostatistical methods to enhance PRO analysis and participate in PRO methodological research for the development of novel analytical techniques. Provide PRO related continuous education training opportunities to BDM staff members at internal forum/meetings Regulatory Support and Compliance Provide biostatistical expertise on PRO analysis during regulatory interactions, and address queries to ensure alignment with regulatory standards by offering statistical guidance for organizational decision-making processes. Stay informed with guidance documents from regulators to industry on use of PROs for regulatory decision making.

Requirements

• PhD in statistics/biostatistics/ epidemiology/health economics with at least 8 years of experience (or MS with at least 13 years of experience) in generating solutions to problems presented by medical and commercial organizations within the biopharmaceutical industry.
• Expertise advanced statistical methodology to support PRO endpoints or different endpoints common to PROs.
• Expertise with analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials).
• Expertise in statistical methods to support Health Economics and Outcomes Research including patient reported outcomes (including development / validation / analysis / interpretation), JCA/HTA/reimbursement/value dossiers.
• Strong experience as study/trial biostatisticians and in statistical methods to support randomized studies, observational (non-randomized) studies, registries, non-interventional studies, cluster randomization, pragmatic clinical trials, etc.
• Experience estimating and planning resource needs and allocation, and vendor management.
• Knowledge of current statistical methods and SAS/R to solve statistical problems

Nice To Haves

• Experience in Oncology/Hematology/Rare Diseases/PRO analysis is highly desired

Responsibilities

• Lead and oversee the end to end process of PRO support from data collection to data analysis within BDM in collaboration with HEOR team ensuring statistical rigor and appropriateness, and regulatory adherence and HTA requirement fulfillment.
• Create, develop and refine PRO statistical analysis plans (PRO SAP), contribute to PRO analysis section in the protocol and clinical study SAP when applicable, authoring technical documents, including statistical analyses plans, programming specifications and TFL mock shells.
• Establish and guide modeling expertise in various PRO instruments under different trial designs, conduct appropriate 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, as well as scientific communication of the results
• Must be able to work collaboratively with statistical programming and provide detailed and timely guidance towards the planned analyses, when external support is needed, oversee vendor selection, contract, budget and project management
• Represent PRO SME at BDM-Biostatistics ELT team
• Develop working knowledge of Regeneron asset(s) and the PRO endpoints needed as part of the overall evidence generation efforts; act as a senior level consultant to select PRO endpoints and apply appropriate tools within therapeutic areas.
• Excellent knowledge on the PRO endpoints and strong understanding of data sources and leverage hands on data review to guide the selection of appropriate PRO endpoints, techniques and methods.
• Solid knowledge on general Clinical Outcome Assessment (COAs) related aspects and up-to-date knowledge on regulatory updates on COAs
• Manage the PRO team with both full time employees and temp workers; mentor junior staff, guiding and developing their capabilities through mentorship, training, and professional growth opportunities while promoting knowledge sharing, continuous learning, and an innovative and collaborative environment.
• Serve as the primary contact for PRO analysis for HEOR team and lead statistical efforts on PRO with BDM, manage timelines, resources, budget, contracts, vendors, and coordinate across departments and external stakeholders
• In terms of external vendor involvement, serve as the primary Regeneron contact for vendor selection, contract, budget and project management
• Stay informed on industry and academic trends on PRO endpoints and analysis, incorporate innovative emerging biostatistical methods to enhance PRO analysis and participate in PRO methodological research for the development of novel analytical techniques.
• Provide PRO related continuous education training opportunities to BDM staff members at internal forum/meetings
• Provide biostatistical expertise on PRO analysis during regulatory interactions, and address queries to ensure alignment with regulatory standards by offering statistical guidance 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!
• For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
• For other countries’ specific benefits, please speak to your recruiter.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree