Eclinicalsolutions

About eClinical Solutions
eClinical Solutions is transforming clinical development with elluminate®, our Clinical Data Cloud, helping life sciences organizations unify, analyze, and unlock the value of their data faster than ever before. By combining a modern cloud platform with expert data services, we empower smarter decisions across the clinical trial lifecycle—accelerating innovation that ultimately improves patient outcomes.
Our engineering teams build enterprise-grade, revenue-generating products at the intersection of cloud, data, analytics, and emerging AI technologies. If you’re excited about building sophisticated software that makes a real-world impact on healthcare, this is the place to do it.
You will make an impact: 
As a Senior Software Engineer, AI Enabled Platforms will be a member of the elluminate product development team. elluminate is a next generation data integration and analytics cloud platform that enables life sciences organizations to optimize the aggregation, standardization, and analysis of their data throughout the clinical development life cycle. You are primarily responsible for the design and development of core modules for the platform and will be involved in all phases of the software development lifecycle such as reviewing functional specifications, design, development, unit testing, code reviews and release management.  
This role is ideal for an experienced engineer who enjoys hands-on development, mentoring others, and bringing modern capabilities—including AI-assisted and agentic workflows—into production-grade systems.
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.  
Your day to day: 
<ul>
<li>Design, develop, test, and deploy scalable, secure, and highly interactive web applications</li>
<li>Own and evolve core platform modules, from concept through release and support</li>
<li>Influence application and system architecture with a focus on performance, reliability, security, and maintainability</li>
<li>Lead by example through clean, well-tested code, thoughtful design reviews, and pragmatic technical decisions</li>
<li>Collaborate closely with Product Management, QA, and other engineers throughout the SDLC</li>
<li>Provide technical mentorship and guidance to other engineers on the team</li>
<li>Diagnoses and resolves complex production issues across distributed systems</li>
<li>Ensure solutions meet eClinical Solutions quality standards and applicable industry regulations</li>
<li>Contribute to technical documentation including design specs, acceptance criteria, and release notes</li>
</ul>
Take the first step towards your dream career. Here is what we are looking for in this role.  
AI &amp; Modern Engineering Focus
We’re actively incorporating AI-powered capabilities into our platform, and you’ll help shape how this is done responsibly and effectively in an enterprise environment. This includes:
<ul>
<li>Integrating LLMs and AI services into .NET- and Python-based systems</li>
<li>Designing and implementing AI-assisted workflows, copilots, or intelligent automation features</li>
<li>Working with agentic AI patterns (e.g., task orchestration, tool-using agents, workflow automation)</li>
<li>Applying prompt engineering, evaluation techniques, and guardrails to ensure reliability and compliance</li>
<li>Collaborating with data and platform teams to operationalize AI—not just prototype it</li>
</ul>
Deep ML expertise is not required—we’re looking for strong engineers who understand how to apply AI capabilities in real products.
What We’re Looking For
<ul>
<li>Bachelor’s or Master’s degree in Computer Science or equivalent practical experience preferred </li>
<li>Expert-level proficiency in C#, .NET, and ASP.NET (MVC/Web APIs)</li>
<li>3-5 years of experience in software design and development using the Microsoft technology stack. </li>
<li>Strong experience building full-stack web applications (Angular, TypeScript, HTML, CSS)</li>
<li>Solid understanding of software design principles, patterns, and best practices</li>
<li>Experience across the full Software Development Lifecycle (Agile preferred)</li>
<li>Proven ability to work independently while collaborating effectively in a fast-paced environment</li>
<li>Excellent communication, documentation, and technical leadership skills</li>
</ul>
AI &amp; Platform Experience
<ul>
<li>Hands-on experience integrating LLM-based services (e.g., OpenAI, Azure OpenAI, or similar) into applications</li>
<li>Experience using Python and/or .NET alongside AI/LLM workflows</li>
<li>Familiarity with agent-based or workflow-driven AI architectures is a strong plus</li>
<li>Understanding of secure and responsible AI usage in enterprise systems</li>
</ul>
Nice to Have
<ul>
<li>Strong SQL expertise (Microsoft SQL Server preferred), including performance tuning</li>
<li>Experience with microservices, distributed systems, and cloud platforms (AWS preferred)</li>
<li>Secure development experience, including awareness of common vulnerabilities and mitigations</li>
<li>Experience with clinical trial data, life sciences, or regulated SaaS environments</li>
<li>Experience building data visualizations or analytics-driven user experiences</li>
</ul>
AI Use Statement
Employees are expected to appropriately leverage company-approved AI tools to improve productivity and quality while adhering to company policies, protecting confidential information, validating AI-generated content, and exercising sound professional judgment. AI is intended to augment—not replace—professional judgment, critical thinking, accountability, and decision-making. Accountability for all work remains with the employee.
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: <a href="https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftopworkplaces.com%2Fcompany%2Feclinical-solutions%2F&amp;data=05%7C02%7Cabrown%40eclinicalsol.com%7C4cfa7e54c4dd4513b8b708de13373e46%7Cc55122ac90d94dc2be1508d0cc3c5114%7C0%7C0%7C638969325148541920%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=idjwFyf1zAA7oHoLAFsbAWxHnw0dbwimaeHmdtvZw%2Fg%3D&amp;reserved=0" rel="noopener noreferrer ugc" target="_blank">https://topworkplaces.com/company/eclinical-solutions/</a>
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
 
 
 
#LI-AB1
 
 
 <div><div><div>Pay Range </div><div>US Pay Ranges </div><div>$132,000—$165,000 USD</div></div></div>

Senior Software Engineer

About eClinical Solutions
eClinical Solutions is transforming clinical development with elluminate®, our Clinical Data Cloud, helping life sciences organizations unify, analyze, and unlock the value of their data faster than ever before. By combining a modern cloud platform with expert data services, we empower smarter decisions across the clinical trial lifecycle—accelerating innovation that ultimately improves patient outcomes.
Our engineering teams build enterprise-grade, revenue-generating products at the intersection of cloud, data, analytics, and emerging AI technologies. If you’re excited about building sophisticated software that makes a real-world impact on healthcare, this is the place to do it.
 
You will make an impact: 
As a Principal Full Stack Software Engineer, you will be a technical leader within the elluminate Product Development team. You’ll help design and build the core services and user experiences of a next-generation clinical data and analytics platform—while influencing architecture, engineering standards, and technical direction.
This role is ideal for an experienced engineer who enjoys hands-on development, mentoring others, and bringing modern capabilities—including AI-assisted and agentic workflows—into production-grade systems.
 
Your day to day: 
<ul>
<li>Design, develop, test, and deploy scalable, secure, and highly interactive web applications</li>
<li>Own and evolve core platform modules, from concept through release and support</li>
<li>Influence application and system architecture with a focus on performance, reliability, security, and maintainability</li>
<li>Lead by example through clean, well-tested code, thoughtful design reviews, and pragmatic technical decisions</li>
<li>Collaborate closely with Product Management, QA, and other engineers throughout the SDLC</li>
<li>Provide technical mentorship and guidance to other engineers on the team</li>
<li>Diagnoses and resolves complex production issues across distributed systems</li>
<li>Ensure solutions meet eClinical Solutions quality standards and applicable industry regulations</li>
<li>Contribute to technical documentation including design specs, acceptance criteria, and release notes</li>
</ul>
AI &amp; Modern Engineering Focus
We’re actively incorporating AI-powered capabilities into our platform, and you’ll help shape how this is done responsibly and effectively in an enterprise environment. This includes:
<ul>
<li>Integrating LLMs and AI services into .NET- and Python-based systems</li>
<li>Designing and implementing AI-assisted workflows, copilots, or intelligent automation features</li>
<li>Working with agentic AI patterns (e.g., task orchestration, tool-using agents, workflow automation)</li>
<li>Applying prompt engineering, evaluation techniques, and guardrails to ensure reliability and compliance</li>
<li>Collaborating with data and platform teams to operationalize AI—not just prototype it</li>
</ul>
Deep ML expertise is not required—we’re looking for strong engineers who understand how to apply AI capabilities in real products.
Take the first step toward your dream career.  Here is what we are looking for in this role. 
 Qualifications:
<ul>
<li>Bachelor’s or Master’s degree in Computer Science or equivalent practical experience </li>
<li>10+ years in software design and development using the Microsoft technology stack preferred </li>
<li>Expert-level proficiency in C#, .NET, and ASP.NET (MVC/Web APIs)</li>
<li>Strong experience building full-stack web applications (Angular, TypeScript, HTML, CSS)</li>
<li>Solid understanding of software design principles, patterns, and best practices</li>
<li>Experience across the full Software Development Lifecycle (Agile preferred)</li>
<li>Proven ability to work independently while collaborating effectively in a fast-paced environment</li>
<li>Excellent communication, documentation, and technical leadership skills</li>
</ul>
AI &amp; Platform Experience
<ul>
<li>Hands-on experience integrating LLM-based services (e.g., OpenAI, Azure OpenAI, or similar) into applications</li>
<li>Experience using Python and/or .NET alongside AI/LLM workflows</li>
<li>Familiarity with agent-based or workflow-driven AI architectures is a strong plus</li>
<li>Understanding of secure and responsible AI usage in enterprise systems</li>
</ul>
Nice to Have
<ul>
<li>Strong SQL expertise (Microsoft SQL Server preferred), including performance tuning</li>
<li>Experience with microservices, distributed systems, and cloud platforms (AWS preferred)</li>
<li>Secure development experience, including awareness of common vulnerabilities and mitigations</li>
<li>Experience with clinical trial data, life sciences, or regulated SaaS environments</li>
<li>Experience building data visualizations or analytics-driven user experiences</li>
</ul>
AI Use Statement
Employees are expected to appropriately leverage company-approved AI tools to improve productivity and quality while adhering to company policies, protecting confidential information, validating AI-generated content, and exercising sound professional judgment. AI is intended to augment—not replace—professional judgment, critical thinking, accountability, and decision-making. Accountability for all work remains with the employee.
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: <a href="https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftopworkplaces.com%2Fcompany%2Feclinical-solutions%2F&amp;data=05%7C02%7Cabrown%40eclinicalsol.com%7C4cfa7e54c4dd4513b8b708de13373e46%7Cc55122ac90d94dc2be1508d0cc3c5114%7C0%7C0%7C638969325148541920%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=idjwFyf1zAA7oHoLAFsbAWxHnw0dbwimaeHmdtvZw%2Fg%3D&amp;reserved=0" rel="noopener noreferrer ugc" target="_blank">https://topworkplaces.com/company/eclinical-solutions/</a>
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
 
#LI-AB1
 <div><div><div>Pay Range </div><div>US Pay Ranges </div><div>$152,000—$190,000 USD</div></div></div>

Principal Software Engineer

eClinical Solutions is a global leader in clinical data intelligence, delivering the elluminate® Clinical Data Cloud® — an AI-powered platform driving agentic data review, SDTM automation, and RBQM for 18 of the top 50 pharmaceutical companies worldwide.
As part of our eNOVA AI-First transformation, we are embedding AI across every pillar of clinical development and enterprise operations — compressing cycle times, improving data quality, and redefining how work gets done.
As we scale our AI capabilities, we are building a high-impact, hands-on AI engineering function focused on delivering real, production-grade automation across the enterprise.
 
You will make an impact:
The Principal AI Engineer – Automation &amp; AI is a hands-on technical leader responsible for designing, building, and deploying AI-powered automation solutions across eClinical Solutions.
This role is builder-first (70–80% hands-on development) and operates within a small, high-output team (2–4 engineers). You will work directly with the CTAO and business leaders to identify high-value use cases and rapidly translate them into working AI systems in production.
This is not a program management or oversight role. You are expected to build, ship, and iterate continuously, leveraging modern AI tooling and agentic frameworks to deliver measurable impact.
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.
 
Your day to day:
Building &amp; Shipping AI Systems
<ul>
<li>Design and deploy agentic AI workflows and automation solutions across enterprise functions including R&amp;D, Engineering, Professional Services, IT, Finance, Sales, and Marketing</li>
<li>Build production-grade systems such as:</li>
<ul>
<li>Multi-agent workflows</li>
<li>RAG-based applications</li>
<li>Document intelligence and summarization pipelines</li>
<li>Workflow and process automation solutions</li>
</ul>
<li>Use modern AI tools and frameworks including:</li>
<ul>
<li>Codex, Claude Code, Gemini, NotebookLM</li>
<li>LangChain, LangGraph, LlamaIndex (or equivalents)</li>
</ul>
<li>Rapidly prototype, validate, and deploy solutions in weeks, not months</li>
</ul>
Owning End-to-End Delivery
<ul>
<li>Translate business problems into working AI systems</li>
<li>Design lightweight architectures and iterate quickly</li>
<li>Develop and implement:</li>
<ul>
<li>Prompt engineering strategies</li>
<li>Orchestration logic</li>
<li>API integrations and data pipelines</li>
<li>Testing, validation, and monitoring frameworks</li>
</ul>
<li>Partner directly with stakeholders to refine outputs and drive adoption</li>
</ul>
Driving High-Velocity Execution
<ul>
<li>Deliver continuous output with weekly or bi-weekly releases</li>
<li>Prioritize use cases based on:</li>
<ul>
<li>ROI and business impact</li>
<li>Technical feasibility</li>
<li>Speed to value</li>
</ul>
<li>Operate with minimal process and high accountability in a fast-paced environment</li>
</ul>
Contributing to Scalable AI Foundations
<ul>
<li>Build and maintain reusable assets including:</li>
<ul>
<li>Prompt templates</li>
<li>Agent design patterns</li>
<li>Integration utilities</li>
</ul>
<li>Contribute to lightweight standards for:</li>
<ul>
<li>Security and data handling</li>
<li>Responsible AI practices</li>
<li>Evaluation and performance monitoring</li>
</ul>
</ul>
Technical Leadership &amp; Mentorship
<ul>
<li>Provide technical guidance to a small team of AI engineers and automation specialists</li>
<li>Lead by example through hands-on contribution</li>
<li>Support the evolution of the AI engineering function as it scales</li>
</ul>
Take the first step towards your dream career. Here is what we are looking for in this role.
 
Qualifications: 
<ul>
<li>Bachelor’s degree in Computer Science, Engineering, Data Science, or a related technical field</li>
<li>6–10+ years of software engineering experience with recent hands-on work in AI/LLM systems</li>
<li>Proven experience building and deploying:</li>
<ul>
<li>LLM-powered applications</li>
<li>Agentic workflows</li>
<li>Automation solutions in production environments</li>
</ul>
<li>Strong hands-on experience with tools such as:</li>
<ul>
<li>Codex, Claude Code, Gemini, NotebookLM (or similar AI-assisted development tools)</li>
<li>LangChain, LangGraph, LlamaIndex, or equivalent frameworks</li>
</ul>
<li>Proficiency in:</li>
<ul>
<li>Python</li>
<li>API development and system integration</li>
<li>Cloud platforms (AWS, Azure, or GCP)</li>
</ul>
</ul>
Preferred
<ul>
<li>Experience with:</li>
<ul>
<li>RAG architectures and vector databases</li>
<li>AI evaluation frameworks, guardrails, and monitoring</li>
<li>Workflow automation tools and enterprise integrations</li>
</ul>
<li>Experience working in regulated environments (e.g., life sciences, healthcare, financial services)</li>
<li>Familiarity with clinical data, CDISC standards, or clinical development workflows</li>
<li>Experience in high-growth or PE-backed SaaS environments</li>
</ul>
AI Use Statement
Employees are expected to appropriately leverage company-approved AI tools to improve productivity and quality while adhering to company policies, protecting confidential information, validating AI-generated content, and exercising sound professional judgment. AI is intended to augment—not replace—professional judgment, critical thinking, accountability, and decision-making. Accountability for all work remains with the employee.
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: <a href="https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftopworkplaces.com%2Fcompany%2Feclinical-solutions%2F&amp;data=05%7C02%7Cabrown%40eclinicalsol.com%7C4cfa7e54c4dd4513b8b708de13373e46%7Cc55122ac90d94dc2be1508d0cc3c5114%7C0%7C0%7C638969325148541920%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=idjwFyf1zAA7oHoLAFsbAWxHnw0dbwimaeHmdtvZw%2Fg%3D&amp;reserved=0" rel="noopener noreferrer ugc" target="_blank">https://topworkplaces.com/company/eclinical-solutions/</a>
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
 <div><div><div>Pay Range </div><div>US Pay Ranges </div><div>$160,000—$200,000 USD</div></div></div>

Principal AI Engineer – Automation & AI

OVERVIEW Experienced Statistical Programmer with expertise in supporting multiple clinical studies through the development, validation, and delivery of high-quality statistical programming outputs. Proficient in SAS (Base SAS, SAS/STAT, and Macro Language) and CDISC standards, including SDTM, ADaM, and TLF development for regulatory submissions. Skilled in creating analysis datasets, safety and efficacy tables, listings, figures, Define.xml, and submission packages compliant with FDA, PMDA, and EMA requirements. Strong knowledge of the clinical drug development process, data automation, safety reporting, DSUR/PSUR deliverables, and Pinnacle 21 validation. Proven ability to collaborate with internal stakeholders, proactively resolve programming issues, and ensure timely, compliant, and accurate study deliverables. Use of R and AI tools to augment, enhance day to day programming is a huge plus. 
KEY TASKS &amp; RESPONSIBILITIES
➢ Led multiple studies on end-to-end programming while serving as the primary point of contact for clients.
➢ Develop specifications and SAS programs for SDTM datasets and clinical data analysis deliverables.
➢ Create specifications and SAS programs for ADaM datasets supporting trial-level reporting and integrated safety and efficacy analyses.
➢ Develop, maintain, and validate Tables, Listings, and Graphs (TLGs) based on biostatistical requirements and Statistical Analysis Plans (SAPs).
➢ Program and QC data listings, summaries, graphs, and statistical models as required.
➢ Design and maintain reusable SAS macros to support Phase I–IV clinical trial reporting.
➢ Generate submission-ready datasets and output using industry standards, SDLC practices, and regulatory requirements.
➢ Collaborate with cross-functional teams to ensure timely delivery of high-quality study outputs.
➢ Maintain project documentation in compliance with SOPs, processes, and quality standards.
➢ Ensure adherence to eClinical Solutions and industry guidelines, procedures, and regulatory expectations.
➢ Ability to independently write R programs and convert SAS programs to R programs using AI tools to create datasets and TLFs. Education &amp; Experience
➢ Basic Science/Bachelor of Science degree (Master in Statistics or related science preferred) in health-related fields, computer science or equivalent experience preferred. ➢ SAS Certified ➢ R programming experience is a plus ➢ Knowledge and experience in using AI to gain programming efficiencies is a plus 
Professional Skills
➢ Minimum 8+ years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred. ➢ Strong experience in preparations for NDA filings ➢ Strong knowledge of E6, E3, E9 guidelines, 21 CFR Part 11 and clinical trial methodologies ➢ Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) ➢ Knowledge of CDISC® related data models like SDTM, and ADAM. ➢ Experience of working on multiple clinical protocols at the same time. ➢ Excellent verbal and written communication skills ➢ Detail oriented, ability to multitask with strong prioritization, planning and organization skills. ➢ Excellent team player
Technical Skills
➢ Advanced SAS programming expertise in data extraction, integration, analysis, reporting, and automation. ➢ Proficient in Base SAS, PROC SQL, Macro Programming, ODS, SAS/GRAPH, SAS/STAT, SAS/CONNECT, and SAS/ACCESS. ➢ Extensive experience with SAS reporting procedures, including PROC SQL, PROC REPORT, PROC SUMMARY / PROC Means, PROC FREQ, and PROC TRANSPOSE, in clinical                 research environments. ➢ Skilled in working with relational databases, SAS performance optimization, and process automation through batch, shell scripting and AI tools. ➢ Experienced in R programming (tidyverse, dplyr, admiral, rtables ggplot2, xportr, flextable) and Git-based version control (GitHub, GitLab). ➢ Experienced in developing Tables, Listings, and Graphs (TLGs) using SAS and R for clinical trial analysis and reporting.

Statistical Programmer Sr

OVERVIEW Experienced Statistical Programmer with expertise in supporting multiple clinical studies through the development, validation, and delivery of high-quality statistical programming outputs. Proficient in SAS (Base SAS, SAS/STAT, and Macro Language) and CDISC standards, including SDTM, ADaM, and TLF development for regulatory submissions. Skilled in creating analysis datasets, safety and efficacy tables, listings, figures, Define.xml, and submission packages compliant with FDA, PMDA, and EMA requirements. Strong knowledge of the clinical drug development process, data automation, safety reporting, DSUR/PSUR deliverables, and Pinnacle 21 validation. Proven ability to collaborate with internal stakeholders, proactively resolve programming issues, and ensure timely, compliant, and accurate study deliverables. Use of R and AI tools to augment, enhance day to day programming is a huge plus. 
KEY TASKS &amp; RESPONSIBILITIES
➢ Develop specifications and SAS programs for SDTM datasets and clinical data analysis deliverables. ➢ Create specifications and SAS programs for ADaM datasets supporting trial-level reporting and integrated safety and efficacy analyses. ➢ Develop, maintain, and validate Tables, Listings, and Graphs (TLGs) based on biostatistical requirements and Statistical Analysis Plans (SAPs). ➢ Program and QC data listings, summaries, graphs, and statistical models as required. ➢ Design and maintain reusable SAS macros to support Phase I–IV clinical trial reporting. ➢ Generate submission-ready datasets and output using industry standards, SDLC practices, and regulatory requirements. ➢ Collaborate with cross-functional teams to ensure timely delivery of high-quality study outputs. ➢ Maintain project documentation in compliance with SOPs, processes, and quality standards. ➢ Ensure adherence to eClinical Solutions and industry guidelines, procedures, and regulatory expectations. ➢ Ability to independently write R programs and convert SAS programs to R programs using AI tools to create datasets and TLFs. Education &amp; Experience
➢ Basic Science/Bachelor of Science degree (Master in Statistics or related science preferred) in health-related fields, computer science or equivalent experience preferred. ➢ SAS Certified ➢ R programming experience is a plus ➢ Knowledge and experience in using AI to gain programming efficiencies is a plus ➢ Excellent written and verbal communication skills in English
Professional Skills
➢ Minimum 4-5 years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred. ➢ Strong experience in preparations for NDA filings ➢ Strong knowledge of E6, E3, E9 guidelines, 21 CFR Part 11 and clinical trial methodologies ➢ Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) ➢ Knowledge of CDISC® related data models like SDTM, and ADAM. ➢ Experience of working on multiple clinical protocols at the same time. ➢ Excellent verbal and written communication skills ➢ Detail oriented, ability to multitask with strong prioritization, planning and organization skills. ➢ Excellent team player
Technical Skills
➢ Advanced SAS programming expertise in data extraction, integration, analysis, reporting, and automation. ➢ Proficient in Base SAS, PROC SQL, Macro Programming, ODS, SAS/GRAPH, SAS/STAT, SAS/CONNECT, and SAS/ACCESS. ➢ Extensive experience with SAS reporting procedures, including PROC SQL, PROC REPORT, PROC SUMMARY / PROC Means, PROC FREQ, and PROC TRANSPOSE, in clinical                 research environments. ➢ Skilled in working with relational databases, SAS performance optimization, and process automation through batch, shell scripting and AI tools. ➢ Experienced in R programming (tidyverse, dplyr, admiral, rtables ggplot2, xportr, flextable) and Git-based version control (GitHub, GitLab). ➢ Experienced in developing Tables, Listings, and Graphs (TLGs) using SAS and R for clinical trial analysis and reporting.

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Principal AI Engineer – Automation & AI

Statistical Programmer Sr

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