Senior Director, Biostatistics - Safety Statistics

Regeneron Pharmaceuticals • Tarrytown, GA

35d

About The Position

Regeneron Pharmaceuticals is seeking a Senior Director, Biostatistics - Safety Statistics to join our organization!! In this role, a typical day might include: The Senior Director, Biostatistics, will lead a new capability group within the Biostatistics department, focused on working closely with Global Patient Safety (GPS) Sciences and will partner with GPS to bring the best statistical approaches for GPS’ core mission of safety surveillance, signal detection, communication of the safety profile, and benefit risk assessment, as well as giving statistical input to regulatory agency submissions and queries. The incumbent will establish the vision and direction for this new group. The Biostatistics Safety Group (BSG) will collaborate closely with the therapeutically aligned statisticians within Biostatistics, as well as the Clinical Development Units, Regulatory Affairs, Statistical Programming, Data Management, and Medical Writing. The BSG works on products in the Regeneron portfolio ranging from pre-IND through approval and post-marketing, with a focus on evaluation, interpretation, and reporting of aggregate/integrated safety data, including benefit risk planning and assessment. The group will also be responsible for ensuring the integrity of safety monitoring in open-label studies and for managing the interface with IDMCs. Regeneron is seeking an experienced statistician to lead this new group. The leader will build the strategy, operating model, processes, and team to partner closely with GPS and to ensure robust, compliant, and innovative evaluation of aggregate safety data. The Senior Director, Biostatistics Safety Group, will report to VP Biostatistics and work with colleagues in Biostatistics, BDM, GPS, Regulatory and with CDU leadership to establish a vision and resourcing model for the group. This role might be for you if you can/have:

Requirements

• 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).

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.
• Oversight of the development, and timely delivery and interpretation of high-quality safety outputs, including graphics.
• Oversight of cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests.
• Oversight 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.

Benefits

• 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!

What This Job Offers

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