Associate Director, Clinical Data Integration & AI Programming

yellow MessageBody About Acadia Pharmaceuticals / yellow Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis along with earlier-stage programs that address other underserved patient needs. At Acadia we’re here to be their difference.

Position Summary

The Associate Director is a hands-on technical role responsible for automating how clinical data are integrated across assigned compounds and studies and for building the reusable R and Python dashboards and data review tools that make those data usable by study teams. Working in R Python SQL and APIs on the Posit platform the role builds automated ingestion pipelines with incoming quality and congruency checks maps disparate source structures into a standardized analysis-ready data model and delivers validated dashboards and review tools built on that foundation. It additionally evaluates and implements applied AI and generative AI capabilities where they measurably improve data processing quality review or programming productivity always under human oversight and in accordance with regulations SOPs and data privacy requirements.

Primary Responsibilities

Clinical Data Integration and Automation

Designs builds and maintains automated pipelines that ingest clinical data from EDC systems central laboratories eCOA and IRT vendors safety systems and other external providers at defined refresh frequencies with scheduling versioning audit trails processing logs and failure alerting Owns the standardized cross-study and cross-compound clinical data model that harmonizes source structures terminology and variables into consistent analysis-ready form and establishes metadata-driven mapping specifications so new studies and vendors onboard without rebuilding pipelines Develops automated incoming data quality and congruency checks including completeness structural conformance visit and date consistency cross-domain reconciliation duplicates and outliers and routes actionable exception outputs to Data Management and study teams Automates laboratory SAE eCOA and IRT reconciliation workflows and develops congruency flags that identify discrepancies across studies compounds and source systems Develops algorithms and data feeds supporting risk-based monitoring and centralized data surveillance Builds controlled APIs and data access components that provide consistent governed access to standardized clinical data for dashboards and downstream programming

R and Python Dashboards and Data Review Tools

Designs develops validates deploys and maintains interactive R/Shiny and Python dashboards for clinical data review and study health monitoring covering enrollment adverse and serious adverse events efficacy data review laboratory trends protocol deviations visit compliance data cleaning status and operational metrics Builds interactive patient profiles data review listings edit check outputs coding review reports and medical review applications transitioning these deliverables from manual or SAS-based workflows into reproducible R/Posit solutions Develops reusable R and Python packages modules visualization components and dashboard templates together with common metric definitions and navigation patterns so outputs are consistent and comparable across studies and compounds Develops automated study team communications including scheduled summaries of enrollment safety events data cleaning status and other key study metrics Partners with Data Management Clinical Operations Clinical Development Safety Biostatistics and Statistical Programming to translate clinical review needs into reliable intuitive dashboard functionality and drives adoption through training and documentation

Engineering Standards Validation and Platform

Operationalizes R/Posit capabilities within Biometrics including Posit Workbench Posit Connect Package Manager controlled package environments application publishing access management and governed deployment Establishes R and Python development standards covering modular design reusable code libraries code review automated testing error handling logging and dependency management and applies Git version control and CI/CD practices to pipelines and applications Owns the lifecycle of pipelines dashboards and reusable components from requirements and prototyping through validation production release monitoring enhancement and retirement with documentation traceability and change control appropriate to a regulated environment Applies established validation documentation and quality standards to assigned pipelines and applications and supports audits and inspections as subject matter expert for the solutions the incumbent has built

Applied AI Capabilities

Evaluates prototypes and implements AI and generative AI capabilities that measurably improve clinical data transformation quality review dashboard summarization metadata and standards search code generation and review assistance or documentation drafting Integrates approved LLM and retrieval augmented generation capabilities into R and Python applications where they deliver clear operational benefit and can be appropriately governed including natural language querying of approved internal standards specifications and study documentation Applies human in the loop review predefined acceptance criteria traceability and validation to AI-assisted outputs and determines when AI-assisted methods are appropriate versus when deterministic validated programming is required

Operational Leadership and Collaboration

Executes the clinical data integration dashboard and automation roadmap across assigned compounds and prioritizes work within an agreed backlog Leads technical and process improvement initiatives within assigned compounds and workstreams and recommends sourcing approaches and tooling for consideration by functional leadership Provides technical oversight of FSP CRO vendor and consultant resources supporting assigned data integration and dashboard development work including specification review and acceptance of their deliverables Partners with study teams Data Management and Biostatistics at the study and compound level to gather requirements resolve issues and drive adoption of delivered tools Provides training mentoring and technical guidance to statistical and clinical programmers on R/Posit Python data automation dashboard development and responsible AI practices Monitors developments in R Python Posit clinical data engineering and AI use in drug development and recommends relevant advances for adoption Other responsibilities as assigned.

Education/Experience/Skills

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 preferably in a pharmaceutical or biotech environment. Demonstrated experience delivering technical solutions that 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 hands-on Python for data ingestion transformation automation analytics and application development 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 understanding of clinical trial data and CDISC standards including SDTM ADaM metadata-driven programming and integrated data structures Working knowledge of SAS and the 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 their limitations and validation implications knowledge of GCP ICH 21 CFR part 11 data privacy access control audit trails and validation expectations for clinical data systems Demonstrates strong written and verbal communication skills conveying complex technical concepts clearly to technical and non-technical stakeholders Balances competing priorities and deadlines ensuring timely and high-quality execution across multiple initiatives Willing and ability to travel domestically and internationally as needed

Physical Requirements

This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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16px In addition to a competitive base salary this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience performance and location.

Salary Range $158,000 $197,900 USD

What we offer US-based Employees

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

EEO Statement (US-based Employees) Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse equitable inclusive and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply especially if the reason you are the best candidate isn’t exactly what we describe here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race including related to hairstyle color religion or religious creed sexual orientation gender gender identity gender expression gender transition country of origin ancestry citizenship age physical or mental disability genetic information legally-protected medical condition or information marital status domestic partner status family care status military caregiver status veteran or military status (including reserve status National Guard status and military service or obligation) status as a victim of domestic violence sexual assault or stalking enrollment in a public assistance program or any basis protected under federal state or local law.

As an equal opportunity employer Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran you have the right to request a reasonable accommodation. Furthermore you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation please complete our a Reasonable Accommodation Request Form;or contact us at a talentacquisition@acadia-pharm.com;or a 858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

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