Clinical Data Programmer

Who we are: At Arkana Laboratories, everyone has an important role to fill. Come join us and be a part of a team dedicated to making life better for those who need it most.

This place is packed with super-smart people who do their best work together. We work hard every day to advance our understanding of disease and provide world-class care to our patients in hopes of leaving our corner of the world a little better than we found it. While we are committed to improving the lives of thousands of patients, we never lose sight of the realization that they are the reason we get to create change in our field.

Built on generosity, teamwork, and the freedom to try new things, we take great pride in our work. Great ideas come from everywhere in this company and we celebrate each success and failure for the opportunity it gives us to keep reaching. For more than twenty years after our founder, Dr. Patrick Walker, wrote his goals on the back of a napkin, our people, culture, and values have remained strong.

Position Summary: The Clinical Data Programmer develops, validates, and maintains Python scripts used to extract, transform, and deliver clinical trial data to pharmaceutical sponsors in compliance with Data Transfer Agreements (DTAs), DB Specifications, and applicable regulatory standards including CDISC/SDTM. The Programmer also supports complex EDC configuration tasks that require programming-level knowledge, including adjudication workflow logic and custom functions in Medidata Rave. This role works closely with the Clinical Trials Data Specialist through paired work, code review, and day-to-day technical partnership.

What you''ll do:

Data Pipeline

• Develop, maintain, and version-control Python scripts for data extraction, transformation, SDTM domain mapping, and production of sponsor-ready output files using Azure DevOps.
• Validate all script output against DTA specifications, DB Specs, and SDTM/CDISC requirements before every production transfer; maintain script self-certification logic.
• Execute test transfers and coordinate with the Data Management team on production release through the Azure DevOps pull request approval workflow.
• Resolve post-transfer technical issues related to file format, structure, encoding, or delivery (Type A issues) and resubmit corrected files per DTA requirements.
• Contribute to DTA technical review, identifying format, encoding, blinding, and delivery requirements that affect script design before build begins.
• Maintain script documentation and change logs in Azure DevOps; support audit readiness for all scripting and transfer-related records.

Complex EDC Support

• Support adjudication workflow design and complex logic in Medidata Rave that exceeds standard build scope, including custom function development (C#).
• Participate in study start-up scoping and UAT activities as the technical representative for data pipeline design and complex EDC logic.

EDC and Data Pipeline Collaboration

• Work closely with the Clinical Trials Data Specialist responsible for EDC build activities to ensure EDC configuration, data structure, and downstream transfer requirements remain aligned.
• Partner on technical review of study requirements, DTAs, DB specifications, amendments, and UAT findings that may affect both EDC build and transfer scripting.
• Review the downstream impact of EDC changes on Python scripts, SDTM/domain mapping, output files, and production transfers.
• Participate in code review, script review, and technical discussions related to data pulls, transformation logic, and transfer readiness.
• Support clear handoffs between EDC build activities and data transfer programming, including documentation of logic, assumptions, changes, and validation steps.

You should have:

Required

• Experience with at least one clinical EDC platform (Medidata Rave, REDCap, Veeva Vault, Oracle Clinical, Inform, or equivalent) - direct hands-on use, not just familiarity.
• Proficiency in Python for data processing, transformation, and file output generation.
• Working knowledge of CDISC clinical data standards, including SDTM domains and controlled terminology.
• Experience with version control tools (Git, Azure DevOps, or equivalent) including branching, commit practices, and pull request workflows.

Preferred

• Experience in a central laboratory, CRO, sponsor data management, or clinical operations environment.
• Exposure to 21 CFR Part 11, GCP, or GCDMP compliance requirements in a data or systems context.
• Experience developing SDTM datasets for regulatory submission or sponsor delivery.
• Comfort working in a small, high-ownership team where roles are defined by what needs to get done, not just a title.

Strong Bonus

• Medidata Rave experience - specifically Rave Architect, Designer, or equivalent build-level familiarity.
• C# programming experience, particularly in the context of Rave custom functions, EDC edit check logic, or similar clinical system programming.

Education: Bachelor's degree preferred. A minimum of 4 years of directly related experience may be considered in lieu of a college degree.

This is a Monday-Friday 8:00AM-5:00PM onsite position at our main office in Little Rock, Arkansas.

What we offer: We know that health is more than doctor visits and life is more than work. We work hard at Arkana but in turn provide competitive salaries and generous benefit offerings.

Specifically, we offer the following benefits to full-time employees:

• Competitive salary
• Generous paid time off and Paid Holidays
• Minimal cost health insurance for you and affordable options for your family
• 401(k) with immediate eligibility and match
• Company-paid life insurance
• Company-paid long term disability coverage
• Affordable vision and dental plans
• Flexible Spending Account or Health Savings Account availability
• Wellness plan and complimentary yoga classes
• Monthly in-office massages and employer-sponsored lunches

Please see Careers for further information.