Senior Manager, Trial Surveillance & Analytics (Hybrid) AbbVie just now

Remote Genie; United States; Hybrid; USD 150,000 - 230,000; Full time

Job summary

AbbVie seeks a Senior Manager in Trial Surveillance & Analytics to own end-to-end data analytics for safety surveillance in ongoing trials. You will build data pipelines, analytics, and tools used by study teams, and apply AI to improve signal detection while collaborating with Patient Safety, Statistics, and Data Engineering.

This role demands hands-on R/Python, SDTM/ADaM experience, and a track record of production-quality analytical solutions in pharma.

Qualifications

• MS (with 8+ years of experience) or PhD (with 4+ years of experience) in Statistics, Biostatistics, Bioinformatics, Machine learning and AI or a highly related field.
• Experience in pharma/biotech/health tech or related industries is preferred.
• Strong hands-on programming in R and Python, plus SQL and Git, with production-quality pipelines.
• Demonstrated experience applying generative or agentic AI to analytical work with measurable results.
• Experience with clinical trial data (CDISC SDTM/ADaM) and/or real-world data (EHR/claims/registries).
• Evidence of analytics tools or solutions adopted by users.

Responsibilities

• Frame surveillance problems with stakeholders, design for adoption, and iterate with users.
• Build data pipelines and analysis-ready data (SDTM/ADaM) for safety and efficacy surveillance.
• Lead blinded, standardized analytics across studies to detect signals early.
• Deliver reporting and automate it wherever possible (tables, listings, figures).
• Develop dashboards and self-service tools; drive adoption and measure usage.
• Apply generative and agentic AI across analysis workflow; build AI agents on clinical data foundations.
• Integrate clinical trial and real-world data as needed; assess data quality and comparability.
• Lead projects and cross-functional pods; mentor team members and collaborate with stakeholders.
• Communicate technical concepts clearly to non-technical audiences; represent team in cross-functional forums.
• Ensure adherence to GCP, ICH guidelines, AbbVie SOPs and quality standards.

Skills

R

Python

SQL

Git

Generative AI

AI/ML

Data pipelines

Education

MS in Statistics/ Biostatistics/ related field

PhD in Statistics/ Biostatistics/ related

Tools

SAS

Plotly/Dash

Streamlit

Shiny

AWS

Job description

AbbVie

United States Senior Data 21h ago

About this role

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

Trial Surveillance & Analytics (TSA) is a newly formed center of excellence in Data & AI Acceleration, part of AbbVie’s Data and Statistical Sciences organization. Our mission is to transform how AbbVie conducts ongoing clinical trial surveillance - integrating trial data, analytics and AI so that study teams and patient safety colleagues see emerging safety and efficacy signals early, and can act on them with confidence. This is work upstream, inside ongoing clinical trials, where insight can still change decisions for the study and for patients.

The Senior Manager, Trial Surveillance & Analytics is a hands-on, full-stack data scientist who takes a surveillance question from intake to a working solution. You will work in a small team that owns a capability end to end - from the data, through the analysis, to the tool that study teams use - and you will own your solutions from problem statement to a working product that people use. The team is AI-native from day one: agentic coding and AI agents are part of how we work, with room to experiment and to scale what works. You will combine depth in one area (such as statistical programming and reporting, data integration, data visualization, data science and machine learning, or data and software engineering) with enough breadth across clinical data, analytics and AI to deliver on your own, with the support of the team. As an early member of a new center of excellence, you will help define how it works, the standards it sets and the capabilities it builds, partnering across Global Patient Safety, therapeutic area clinical development teams, Statistics, Statistical Programming and data engineering across the portfolio.

Key Responsibilities:

• Frame surveillance problems with stakeholders before building: understand the decision to be supported, design for adoption, and iterate 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 - tables, listings and figures, safety reports and listings - and automate it wherever possible.
• Develop applications, dashboards and self-service tools that study teams and patient safety colleagues use themselves; drive their adoption and measure their use.
• Apply generative and agentic AI across the analysis workflow, build AI agents on the clinical data foundation, and measure the gain in time and quality.
• Integrate clinical trial and real-world data where the science requires it, assessing comparability and data quality first.
• Lead projects and small cross-functional pods; coach and mentor team members. 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.

Qualifications

Minimum Qualifications:

• MS (with 8+ years of experience) or PhD (with 4+ 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 (e.g. 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 (e.g. CDISC SDTM/ADaM) and/or real-world data (e.g. EHR, claims, registries).
• A track record of building analytical tools or solutions that were adopted and sustained by their users.
• Strong communication skills, including the ability to explain analytical and technical concepts in plain language and to influence cross-functional partners without direct authority.

Preferred Qualifications:

• Experience designing and building agentic AI systems (e.g. multi-step agents, tool use, retrieval and evaluation), with a track record of 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 of methods for real-world evidence, such as cohort definition, confounding control and external comparators.
• Experience building interactive visualizations and data apps with modern frameworks (e.g. Plotly / Dash, Streamlit, Shiny, React / D3) and deploying on cloud platforms (e.g. 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html