Sr. Director, Statistical programming Safety

Contact: Lauren Scutero – lscutero@penfieldsearch.comPosition SummaryThis is a permanent, hybrid position in Foster City, CA with two optional work‑from‑home days (Monday, Friday). Core collaboration days in the office are Tuesday, Wednesday, and Thursday. Fully home‑based work is not available for this role.Key ResponsibilitiesLead end‑to‑end programming strategy and execution for compound level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI).Provide strategic oversight of roles, responsibilities, and build steps for aggregate safety programming delivery.Serve as escalation point for complex pooled/cumulative safety analyses and urgent ad‑hoc safety requests.Maintain hands‑on engagement to ensure technical correctness, reproducibility, and delivery reliability for critical outputs.Ensure consistent processes, folder structures, and operational readiness for safety programming deliverables.Own and continuously improve quality management practices, including definition and monitoring of KPIs.Provide vendor/FSP oversight and governance, ensuring training readiness, documented expectations, and appropriate QC.Lead, mentor, and develop Safety Statistical Programming staff; oversee less experienced colleagues and contribute to development of standards, tools, and templates.Drive adoption of AI‑enabled and automated programming approaches to improve efficiency, consistency, and quality.Capabilities & RequirementsExcellent written and verbal communication; strong influencing and negotiation skills.Deep knowledge of drug development, regulatory expectations, and industry standards for safety programming and reporting.Proven ability to lead people leaders, delegate effectively, coach performance, and support career development.Strong judgment and problem‑solving skills in complex situations; ability to prioritize critical issues.Demonstrated ability to work cross‑functionally and influence decision making.Education & ExperienceBachelor's degree or higher in Biostatistics, Computer Science, or a related field with 12+ years of relevant industry experience.6+ years of leadership or cross‑functional project management experience, including managing project teams.Significant line management experience with a proven record of hiring and developing high‑performing talent.Extensive experience with SAS®; experience with R and/or Python preferred.Demonstrated leadership in change management and standards adoption.The salary range for this position is: $226,185.00 - $292,710.00.#J-18808-Ljbffr