Associate Director, Clinical Data Integration, AI Programming

Job not on LinkedIn

🔥 35 minutes ago

🇺🇸 United States – Remote

💵 $158k - $197.9k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Acadia Pharmaceuticals Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1993

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $287.5M Post-IPO Equity on 2019-09

Healthcare • Pharmaceuticals • Biotechnology

Acadia Pharmaceuticals Inc. is a pharmaceutical company specializing in breakthroughs in neuroscience to enhance lives. For over 30 years, Acadia has been at the forefront of healthcare, pioneering treatments for conditions like Parkinson’s disease psychosis and Rett syndrome. The company's focus is on developing innovative and novel medicines that address unmet medical needs, especially in therapeutic areas with high demand, such as Prader-Willi syndrome, Alzheimer’s disease psychosis, and other central nervous system disorders. Acadia is dedicated to elevating life by embracing diverse perspectives, fostering collaboration, and advancing scientific research and development.

📋 Description

• Design, build, and maintain automated clinical data ingestion pipelines with scheduling, versioning, audit trails, processing logs, and failure alerting • Own and maintain a standardized cross-study and cross-compound clinical data model and metadata-driven mapping specifications • Develop automated data quality, congruency, reconciliation, exception-routing, risk-based monitoring, and centralized data surveillance workflows • Build controlled APIs and governed data access components for standardized clinical data • Design, develop, validate, deploy, and maintain interactive R/Shiny and Python dashboards for clinical data review and study health monitoring • Build patient profiles, data review listings, edit check outputs, coding review reports, and medical review applications • Develop reusable R and Python packages, modules, visualization components, dashboard templates, metric definitions, and navigation patterns • Automate study team communications with scheduled summaries of key study metrics • Partner with Data Management, Clinical Operations, Clinical Development, Safety, Biostatistics, and Statistical Programming to translate review needs into dashboard functionality and drive adoption • Operationalize Posit Workbench, Posit Connect, Package Manager, controlled package environments, application publishing, access management, and governed deployment • Establish R/Python development standards, code review, automated testing, error handling, logging, dependency management, Git version control, and CI/CD practices • Own the lifecycle of pipelines, dashboards, and reusable components from requirements through validation, release, monitoring, enhancement, and retirement • Apply validation, documentation, quality, traceability, and change-control standards; support audits and inspections as a subject matter expert • Evaluate and implement AI and generative AI capabilities for clinical data transformation, quality review, summarization, standards search, code assistance, and documentation • Integrate approved LLM and retrieval augmented generation capabilities with appropriate governance • Apply human-in-the-loop review, acceptance criteria, traceability, and validation to AI-assisted outputs • Execute the clinical data integration, dashboard, and automation roadmap across assigned compounds and prioritize backlog work • Lead technical and process improvement initiatives and recommend sourcing approaches and tooling • Provide technical oversight of FSP, CRO, vendor, and consultant resources and review their deliverables • Gather requirements, resolve issues, drive tool adoption, and provide training, mentoring, and technical guidance • Monitor developments in R, Python, Posit, clinical data engineering, and AI use in drug development; recommend relevant advances

🎯 Requirements

• Bachelor’s degree in statistics, biostatistics, computer science, data science, biomedical informatics or a related science field; an equivalent combination of relevant education and experience may be considered • Targeting 10 years of progressively responsible experience in statistical programming, clinical programming, clinical data engineering, or clinical analytics; demonstrated experience delivering technical solutions that span multiple studies is required • Advanced hands-on R programming, including Shiny, tidyverse, data.table, R Markdown/Quarto, package development, modular application design, and reproducible workflows • Strong hands-on Python for data ingestion, transformation, automation, analytics, and application development • Strong SQL proficiency and experience building and consuming REST APIs • Demonstrated experience developing and deploying interactive clinical dashboards, patient profiles, data review tools, or study monitoring applications used by study teams • Demonstrated experience designing automated ingestion, transformation, mapping, validation, and refresh processes for structured and semi-structured clinical data • Experience standardizing and integrating EDC, laboratory, eCOA, safety, IRT, and operational data across multiple studies or programs • Experience with Posit/RStudio Workbench, Posit Connect, and Posit Package Manager, or comparable enterprise R and Python environments • Experience with Git version control, automated testing, CI/CD, logging, monitoring, and controlled software deployment • Strong understanding of clinical trial data and CDISC standards, including SDTM, ADaM, metadata-driven programming, and integrated data structures • Working knowledge of SAS and ability to bridge established SAS workflows with modern R and Python solutions • Practical understanding of GenAI, LLMs, RAG, and AI-assisted programming in regulated environments, including limitations and validation implications • Strong knowledge of GCP, ICH, 21 CFR part 11, data privacy, access control, audit trails, and validation expectations for clinical data systems • Strong written and verbal communication skills • Ability to balance competing priorities and deadlines across multiple initiatives • Willing and able to travel domestically and internationally as needed • Ability to work independently from remote locations and travel independently overnight and/or work after hours as required

🏖️ Benefits

• Competitive base, bonus, new hire and ongoing equity packages • Medical, dental, and vision insurance • Employer-paid life, disability, business travel and EAP coverage • 401(k) Plan with a fully vested company match 1:1 up to 5% • Employee Stock Purchase Plan with a 2-year purchase price lock-in • 15+ vacation days • 13 -15 paid holidays, including office closure between December 24th and January 1st • 10 days of paid sick time • Paid parental leave benefit • Tuition assistance