
Principal Stat Programmer
2 weeks ago
Job Summary:
- Serve as a technical subject matter expert (SME) for CDISC and other industry and regulatory standards.
- Contribute to the development of standardized programming tools, macros, and SOPs for efficiency and compliance.
- Lead multiple complex and/or global clinical trial programming projects, mentoring and guiding statistical programming teams.
- Ensure compliance of programming deliverables with CDISC standards, regulatory requirements, and internal guidelines.
Key Responsibilities:
- Collaborate with biostatistics and programming teams to establish SOPs, guidelines, policies, and procedures.
- Develop and optimize programming tools and macros for standardization and efficiency.
- Serve as an SME on CDISC standards:
- Provide guidance and training to Biostatistics and other departments on CDISC usage.
- Conduct compliance reviews of project deliverables (SDTM, ADaM, DEFINE.XML, and other regulatory documents).
- Participate in industry standards organizations and provide updates to the Biometrics department.
- Transfer deliverables and coordinate with cross-functional teams for project execution.
- Mentor junior programmers and support their understanding of CDISC standards and clinical trial processes.
- Perform other work-related duties and minimal travel as required.
Qualifications:
- Undergraduate degree in a scientific or statistical discipline (or equivalent combination of education and experience).
- Extensive SAS or equivalent programming experience in clinical trial environments.
- Knowledge and hands-on experience with CDISC standards (SDTM, ADaM, DEFINE.XML).
- Regulatory submission experience preferred.
- Proven experience leading multiple complex or global projects.
- Experience mentoring others in clinical trial processes and CDISC standards.
- Excellent written and verbal communication skills; proficiency in English.
Skills Required:
- SAS programming and clinical data analysis
- CDISC Standards (SDTM, ADaM, DEFINE.XML)
- Clinical trial data management and regulatory compliance
- SOP development and process standardization
- Mentoring and team leadership
- Regulatory submission experience
- Problem-solving and analytical thinking
- Communication and presentation skills
- Cross-functional collaboration
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