Job Details
Senior Statistical Programmer – ADaM Data Standards
5989
Posted: 15/10/2025
- $160000
- Remote - US / Canada, Colorado, United States
- Permanent
Senior Statistical Programmer – ADaM Data Standards | Leading CRO – FSP | Fully Remote - US or Canada |
Are you an expert in ADaM data standards with a strong grasp of regulatory requirements and clinical data structures? We are seeking a Senior Statistical Programmer (Standards Specialist) to join our fully remote team.
This is not a traditional study programming role. Instead, you will focus on the design, governance, and continuous improvement of ADaM standards that underpin global clinical development. Your expertise will directly shape how data is structured, reviewed, and submitted to health authorities, ensuring compliance, quality, and consistency across programs.
Key responsibilities:
What you will bring:
What you need to have:
Why join?
If you’re passionate about data standards, regulatory compliance, and advancing global best practices in ADaM, please apply today!
Are you an expert in ADaM data standards with a strong grasp of regulatory requirements and clinical data structures? We are seeking a Senior Statistical Programmer (Standards Specialist) to join our fully remote team.
This is not a traditional study programming role. Instead, you will focus on the design, governance, and continuous improvement of ADaM standards that underpin global clinical development. Your expertise will directly shape how data is structured, reviewed, and submitted to health authorities, ensuring compliance, quality, and consistency across programs.
Key responsibilities:
- Lead programming standardization activities and departmental initiatives focused on ADaM.
- Develop, review, and maintain ADaM standards in alignment with regulatory requirements (FDA, PMDA, EMA), CDISC standards, and TAUGs.
- Evaluate changes in data collection and SDTM standards for impacts on ADaM CORE standards.
- Collaborate cross-functionally with the Macro team, CDMA, Clinical Development, and Regulatory Affairs.
- Review and provide input into ADaM submission packages for multiple health authorities.
- Partner with Analysis & Reporting to identify downstream impacts on TFL standards.
- Ensure consistency and quality assurance across standards applied to multiple studies and programs.
What you will bring:
- Deep expertise in ADaM and SDTM standards, with proven knowledge of regulatory submission requirements.
- Experience in developing and maintaining standards, frameworks, and submission-ready deliverables.
- Strong ability to identify issues and propose practical, standards-driven solutions.
- Excellent communication skills—able to work effectively across scientific, regulatory, and technical teams.
- A self-motivated and detail-oriented approach, with the ability to work independently on multiple initiatives.
What you need to have:
- BS degree in Biostatistics, Computer Science, or related field with 5+ years of relevant experience, OR
- MS degree in Biostatistics, Computer Science, or related field with 3+ years of relevant experience.
- Extensive experience working in Oncology.
Why join?
- Fully remote opportunity within the US or Canada.
- Work on initiatives that shape the future of ADaM programming standards across global clinical development.
- Be part of a collaborative team driving regulatory excellence and innovation in clinical data science.
If you’re passionate about data standards, regulatory compliance, and advancing global best practices in ADaM, please apply today!
Jo Fornaciari
Principal Consultant | Biometrics
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