Senior Director, Biostatistics - Safety Statistics

Role Summary

Lead the Biostatistics Safety Group (BSG), a new capability within Biostatistics, partnering with Global Patient Safety Sciences to apply advanced statistics to safety surveillance, signal detection, safety communications, and benefit-risk assessment. Provide statistical input to regulatory submissions and queries; establish the vision and operating model for the group. The BSG collaborates with therapeutically aligned statisticians, Clinical Development Units, Regulatory Affairs, Statistical Programming, Data Management, and Medical Writing, and focuses on evaluation, interpretation, and reporting of aggregate safety data across Regeneron’s portfolio, including benefit-risk planning and assessment. The group ensures integrity of safety monitoring in open-label studies and interfaces with IDMCs.

Responsibilities

• Oversee development of key processes and templates for analyzing safety data from Regeneron clinical development projects, including safety-related contents of Statistical Analysis Plans (SAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs), ensuring consistency, quality, and audit-readiness across programs.
• Provide strategic input to and oversight of the development of Safety SAPs and ISS SAPs.
• Assess the impact of safety findings of external data on Regeneron-developed medications, and assess the impact of new regulatory guidances on how Regeneron analyzes and interprets safety data.
• Provide strategic input on safety-related submissions to regulatory agencies and responses to requests from regulatory agencies.
• Provide strategic statistical leadership for safety deliverables across the portfolio (pre-IND to post-marketing), including integrated safety analyses to support regulatory submissions and responses.
• Serve as statistical lead at regulatory meetings; guide statistical strategy for safety-related briefing materials, queries, and inspection readiness.
• Lead statistical contributions and provide oversight of contributions by Safety Statistics to benefit-risk planning and assessment, including ensuring effective delivery and communication of benefit-risk data analyses and visualizations to internal and external stakeholders.
• Ensure appropriate interpretation of safety deliverables in collaboration with other functions.
• Oversee the development, and timely delivery and interpretation of high-quality safety outputs, including graphics.
• Oversee cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests.
• Oversee to ensure the delivery of high-quality outputs according to agreed-upon timelines.
• Identify potential areas to improve processes or statistical methodologies, initiate steps to evaluate possible improvements and develop a plan to implement changes based on this evaluation.
• Lead and/or represent Biostatistics on cross-functional efforts to implement strategic initiatives that address processes related to monitoring, assessing, interpreting, and reporting safety data.
• Represent Regeneron on external initiatives to advance the safety discipline (e.g., ASA, PHUSE, DIA, etc.), in collaboration with Statistical Programming and Biostatistics.
• Mentor team members and provide appropriate development opportunities.

Qualifications

• MS (with at least 15+ years of experience) or PhD (with at least 10+ years of experience) in Statistics, Biostatistics, or a highly related field, with at least 9 years (MS) or 7 years (PhD) of experience in pharmaceutical development.
• Minimum of 2 years of management experience required for people managers.
• Excellent English communication skills, both oral and written.
• Advanced knowledge of statistical methodology including experimental design, descriptive statistics, inferential statistics, and statistical programming.
• Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience.
• In-depth knowledge and understanding in application of standard business procedures (regulatory guidance, global regulations, ethical issues associated with scientific research trials, SOPs, etc.).
• Experience interacting with regulatory agencies.
• Experience in leading NDA, BLA, and or CTD submission preferred.
• Oversight of multiple safety-related projects (e.g., ISS, SSAP, benefit-risk assessment, signal detection).