Position Summary:
Associate Director, Analysis Oversight Lead RWE Safety: Inflammation. Oversight of timeliness and quality of safety programming and analysis deliverables for CDS-RWE Inflammation (therapeutic area). Reports to CDS-RWE Safety Epidemiologist Lead; partners with scientific leads and Patient Safety stakeholders to translate requirements into compliant programming/analysis. Primary point of contact for analysis and service vendors; responsible for planning, execution, and quality acceptance. Requires experience managing complex analytical workflows in GxP-compliant programming to meet time-critical deadlines.
Key Responsibilities:
- Track/prioritize/deliver programming and analysis deliverables to meet pharmacoepidemiology and safety requirements.
- Ensure compliant, traceable processes for deliverables.
- Manage vendors: performance management, risk escalation, oversight plans, and quality checks.
- Own end-to-end oversight: timely, high-quality completion with proactive risk identification/mitigation.
- Review quality of deliverables (specifications, programs, cohorts, feasibility, results, publications/abstracts).
- Ensure compliance with quality/regulatory requirements; lock/archive outputs as appropriate.
- Coordinate analysis utilization/assignment to vendors; resolve quality/scope/timeliness issues; maintain milestone communication.
- Onboard vendors to tools/environments/data access; identify efficiency improvements; collaborate across oversight roles for consistency.
Basic Qualifications:
- Bachelorβs + 10+ years OR Masterβs + 8+ years OR PhD + 2+ years.
Qualifications / Skills (required & preferred):
- 5+ years as data scientist/analyst for observational research deliverables.
- BS required (CS/Data Science/Biostatistics/Epidemiology or equivalent); MS preferred.
- Hands-on primary and real-world data sources; SAS/R; GxP-compliant systems.
- Lead/manage programmers and analysts; review outputs for quality/completeness/best practices.
- Communicate scope/standards and interpret analysis results; data-driven problem-solving.
- Cross-functional collaboration; strong written/verbal skills.
- Preferred: RWE regulatory landscape; international datasets/Common Data Models (e.g., OMOP).
People Leader Accountabilities:
- Create Inclusion; Develop Talent; Empower Teams.
Compensation/Benefits:
- Salary range: $165,495.00β$214,170.00. May include discretionary bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.