Contact: Lauren Scutero -
teamnt@penfieldsearch.com
This is a permanent, hybrid position in Raleigh, NC with two days (Monday, Friday) as optional work from home with core collaboration days in the office: Tues, Wed, Thurs. Fully home-based work is not available for this role.
Job Description Position Summary
Provides strategic, operational, and hands on (player coach) leadership for compound level safety statistical programming and aggregate safety reporting deliverables, including DSUR, PSUR/PBRER, Risk Management Plan (RMP), IBRSI, and support for broader safety surveillance and safety analytics. Leads teams and oversees vendors to ensure timely, high quality, and inspection ready delivery while driving modernization through AI enabled and automated programming approaches.
Key Responsibilities
- Lead 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 & Requirements
- Excellent 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 & Experience
- Bachelor’s degree or higher in Biostatistics, Computer Science, or 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.