Location: 100% Remote in UK, Poland, Netherlands, Spain, South Africa and India.

Required Skills

- Strong hands-on experience with R programming
- Experience with clinical trial data and CDISC standards
- Ability to rapidly prototype practical automation solutions from user requirements.
- Ability to refactor prototypes into maintainable, reusable, and documented solutions.
- Familiarity with Git-based version control, code review, testing, and CI/CD concepts.
- Practical familiarity with AI-assisted workflows, such as using large language models to support coding, documentation, summarization, review, or structured workflow automation.
- Ability to evaluate AI-generated outputs critically and design workflows with appropriate human review.
- Ability to write transparent technical documentation and user guidance.
- Strong communication skills and ability to work with both technical and non-technical stakeholders.

Preferred Skills

- Experience in pharmaceutical, biotech, or CRO environment
- Knowledge of GxP, validation, auditability, and regulated reporting expectations
- Familiarity with prompt design, prompt evaluation, structured outputs, and repeatable AI-assisted workflows.
- Experience evaluating AI outputs for accuracy, completeness, consistency, and fit for purpose.
- Experience with Shiny, dashboards, lightweight web applications, or interactive review tools.
- Familiarity with JavaScript, HTML, and CSS sufficient to customize R-based interfaces or integrate existing web components where needed.
- Experience packaging of reusable components for team or enterprise use.

Scope of work: Closely working with AI and automation leads in FSP Early Development Advanced Quantitative Sciences to support

- Rapidly identify, design, build,



and test focused proof-of-concept solutions with an initial user group.
- Work with statisticians, programmers, data scientists, and study teams to identify concrete automation or AI-enabled workflow opportunities.
- Define small, realistic PoC scopes with clear success criteria, expected users, assumptions, limitations, and evaluation criteria.
- Build lightweight R-based prototypes, such as reusable R functions or packages, automated reports or documentation, exploratory analysis templates, clinical data review or analysis tools, AI-assisted tools for summarization, drafting or structured information extraction.
- Test prototypes with small groups of statisticians, programmers, or other users.
- Collect feedback on usability, usefulness, limitations, scalability, and iterate based on feedback.
- Progress successful prototypes into maintainable solutions by refactoring code, adding documentation, improving test coverage, and preparing components for reuse.
- Integrate AI or LLM capabilities into R-based workflows where appropriate, using approved tools, APIs, or platforms.
- Design human-in-the-loop workflows that include appropriate review, validation, and documentation of AI-assisted outputs.
- Support reproducible, traceable, and maintainable development practices suitable for a regulated clinical development environment.

Qualification: Master’s degree/PhD in Statistics, Biostatistics, Data Science, Computer Science, Bioinformatics, Life Sciences, Pharmaceutical Sciences, or a related field. Advanced degrees in quantitative disciplines are preferred.

5+ years of relevant experience in clinical development analytics, statistical programming, clinical automation, or a related role within the pharmaceutical, biotechnology, or CRO industry.

Preferred: Pharma, biotech, or CRO experience with regulated clinical development environments.

📌 Clinical Automation Workflow Developer (India)
🏢 Cytel
📍 India