Senior Manager, Trial Surveillance & Analytics (Hybrid)
About The Position
Trial Surveillance & Analytics (TSA) is a newly formed center of excellence in Data & AI Acceleration within AbbVie's Data and Statistical Sciences organization. Its mission is to transform ongoing clinical trial surveillance by integrating trial data, analytics, and AI so study teams and patient safety colleagues can identify emerging safety and efficacy signals early and act confidently. The Senior Manager is a hands-on, full-stack data scientist who takes surveillance questions from intake through working solutions. This role owns solutions end to end, from problem definition and data through analysis and tools used by study teams. The team uses agentic coding and AI agents, with opportunities to experiment and scale effective approaches. The Senior Manager combines depth in an area such as statistical programming and reporting, data integration, visualization, data science and machine learning, or data and software engineering with breadth across clinical data, analytics, and AI. As an early member of the center of excellence, this role helps define its operating model, standards, and capabilities. It partners across Global Patient Safety, therapeutic area clinical development teams, Statistics, Statistical Programming, and data engineering across the portfolio. The role may include indirect supervision of employees and contract staff.
Requirements
- MS with 8 or more years of experience, or PhD with 4 or more years of experience, in Statistics, Biostatistics, Bioinformatics, Machine Learning and AI, or a highly related field.
- Experience may be in pharmaceutical, biotech, health technology, or related industries.
- Strong hands-on programming in R and Python, plus SQL and version control such as Git, with a track record of writing production-quality code for end-to-end analytical pipelines.
- Demonstrated experience applying generative or agentic AI to analytical or programming work, with measurable results.
- Experience working with clinical trial data, such as CDISC SDTM/ADaM, and/or real-world data, such as EHR, claims, or registries.
- A track record of building analytical tools or solutions adopted and sustained by their users.
- Strong communication skills, including explaining analytical and technical concepts in plain language and influencing cross-functional partners without direct authority.
Nice To Haves
- Experience designing and building agentic AI systems, such as multi-step agents, tool use, retrieval, and evaluation, with solutions delivered and used in production.
- Experience in clinical development, drug safety, pharmacovigilance, clinical trial monitoring, or regulatory evidence generation.
- Knowledge of clinical trial design and real-world evidence methods, such as cohort definition, confounding control, and external comparators.
- Experience building interactive visualizations and data apps with modern frameworks such as Plotly/Dash, Streamlit, Shiny, or React/D3, and deploying on cloud platforms such as AWS.
- Familiarity with SAS.
- Experience leading cross-functional initiatives; formal business or leadership training is a plus.
- Publications, presentations, or community leadership in data science, statistics, or AI.
Responsibilities
- Frame surveillance problems with stakeholders before building by understanding the decision to support, designing for adoption, and iterating with users.
- Design and build data pipelines and analysis-ready integrated data on SDTM, ADaM, and integrated databases to support safety and efficacy surveillance.
- Lead blinded, standardized analytics across studies and compounds to detect emerging safety and efficacy signals early.
- Deliver reporting, including tables, listings and figures, safety reports and listings, and automate it wherever possible.
- Develop applications, dashboards, and self-service tools for study teams and patient safety colleagues; drive adoption and measure use.
- Apply generative and agentic AI across the analysis workflow, build AI agents on the clinical data foundation, and measure gains in time and quality.
- Integrate clinical trial and real-world data when scientifically appropriate, assessing comparability and data quality first.
- Lead projects and small cross-functional pods, and coach and mentor team members; the role may include indirect supervision of employees and contract staff.
- Represent the team in cross-functional forums and communicate technical concepts and results clearly to non-technical audiences.
- Ensure adherence to applicable regulations, Good Clinical Practice (GCP), ICH guidelines, AbbVie Standard Operating Procedures (SOPs), and functional quality standards.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
