Senior Director, Biostatistics - Safety Statistics
Regeneron
9 hours ago
On-site
Tarrytown, NY
Clinical Research and Development
Responsibilities:
- Lead a new Biostatistics capability group focused on partnering with Global Patient Safety (GPS) Sciences for safety surveillance, signal detection, communication of safety profile, and benefit-risk assessment.
- Establish the vision and direction; build strategy, operating model, processes, and team.
- Collaborate with therapeutically aligned statisticians and cross-functional partners (Clinical Development Units, Regulatory Affairs, Statistical Programming, Data Management, Medical Writing) to evaluate, interpret, and report aggregate/integrated safety data (pre-IND through approval and post-marketing).
- Ensure integrity of safety monitoring in open-label studies and manage interface with IDMCs.
- Oversee development of key processes and templates for analyzing safety data, including safety-related content of Statistical Analysis Plans (SAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs) for consistency, quality, and audit-readiness.
- Provide strategic input and oversight for development of Safety SAPs and ISS SAPs.
- Assess impact of external safety findings and new regulatory guidance on safety analysis and interpretation.
- Provide strategic input for safety-related regulatory submissions and responses to regulatory agency requests.
- Provide statistical leadership for safety deliverables across the portfolio, including integrated safety analyses.
- Serve as statistical lead at regulatory meetings; guide statistical strategy for briefing materials, queries, and inspection readiness.
- Lead/oversee safety statistics contributions to benefit-risk planning and assessment, including delivery and communication of analyses and visualizations.
- Ensure appropriate interpretation of safety deliverables in collaboration with other functions.
- Oversee timely delivery and interpretation of high-quality safety outputs (including graphics), and cross-functional output specifications for planned and ad hoc analyses.
- Identify opportunities to improve safety processes/methodologies; evaluate and implement changes.
- Lead and/or represent Biostatistics on cross-functional initiatives related to monitoring, assessing, interpreting, and reporting safety data.
- Represent the company on external safety-discipline initiatives (e.g., ASA, PHUSE, DIA) with Statistical Programming and Biostatistics.
- Mentor team members and provide development opportunities.
Qualifications:
- MS in Statistics/Biostatistics (15+ years) or PhD in Statistics/Biostatistics (10+ years) with at least 9 years (MS) or 7 years (PhD) of pharmaceutical development experience.
- Minimum 2 years of management experience (people manager).
- Advanced knowledge of statistical methodology (experimental design, descriptive/inferential statistics, statistical programming).
- Demonstrated experience managing and completing multiple projects.
- In-depth understanding of standard business procedures (regulatory guidance, global regulations, ethics in scientific research trials, SOPs, etc.).
- Excellent English communication skills (oral and written).
- Experience interacting with regulatory agencies.
- Preferred: experience leading NDA, BLA, and/or CTD submissions.
Preferred/Required Skills (as stated):
- Oversight of multiple safety-related projects (e.g., ISS, SSAP, benefit-risk assessment, signal detection).
- Lead a new Biostatistics capability group focused on partnering with Global Patient Safety (GPS) Sciences for safety surveillance, signal detection, communication of safety profile, and benefit-risk assessment.
- Establish the vision and direction; build strategy, operating model, processes, and team.
- Collaborate with therapeutically aligned statisticians and cross-functional partners (Clinical Development Units, Regulatory Affairs, Statistical Programming, Data Management, Medical Writing) to evaluate, interpret, and report aggregate/integrated safety data (pre-IND through approval and post-marketing).
- Ensure integrity of safety monitoring in open-label studies and manage interface with IDMCs.
- Oversee development of key processes and templates for analyzing safety data, including safety-related content of Statistical Analysis Plans (SAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs) for consistency, quality, and audit-readiness.
- Provide strategic input and oversight for development of Safety SAPs and ISS SAPs.
- Assess impact of external safety findings and new regulatory guidance on safety analysis and interpretation.
- Provide strategic input for safety-related regulatory submissions and responses to regulatory agency requests.
- Provide statistical leadership for safety deliverables across the portfolio, including integrated safety analyses.
- Serve as statistical lead at regulatory meetings; guide statistical strategy for briefing materials, queries, and inspection readiness.
- Lead/oversee safety statistics contributions to benefit-risk planning and assessment, including delivery and communication of analyses and visualizations.
- Ensure appropriate interpretation of safety deliverables in collaboration with other functions.
- Oversee timely delivery and interpretation of high-quality safety outputs (including graphics), and cross-functional output specifications for planned and ad hoc analyses.
- Identify opportunities to improve safety processes/methodologies; evaluate and implement changes.
- Lead and/or represent Biostatistics on cross-functional initiatives related to monitoring, assessing, interpreting, and reporting safety data.
- Represent the company on external safety-discipline initiatives (e.g., ASA, PHUSE, DIA) with Statistical Programming and Biostatistics.
- Mentor team members and provide development opportunities.
Qualifications:
- MS in Statistics/Biostatistics (15+ years) or PhD in Statistics/Biostatistics (10+ years) with at least 9 years (MS) or 7 years (PhD) of pharmaceutical development experience.
- Minimum 2 years of management experience (people manager).
- Advanced knowledge of statistical methodology (experimental design, descriptive/inferential statistics, statistical programming).
- Demonstrated experience managing and completing multiple projects.
- In-depth understanding of standard business procedures (regulatory guidance, global regulations, ethics in scientific research trials, SOPs, etc.).
- Excellent English communication skills (oral and written).
- Experience interacting with regulatory agencies.
- Preferred: experience leading NDA, BLA, and/or CTD submissions.
Preferred/Required Skills (as stated):
- Oversight of multiple safety-related projects (e.g., ISS, SSAP, benefit-risk assessment, signal detection).