Job Title: Principal Statistical Programmer
🌍 Available Locations: 3 (Specific sites not listed)
🏢 Category: Clinical
🆔 Job ID: 25189
Job Summary
The Principal Statistical Programmer serves as the Lead Programmer responsible for planning, execution, and oversight of statistical programming activities across clinical studies.
This includes SDTM/ADaM dataset development, TFL generation, QC review, and regulatory submission deliverables, while ensuring compliance, efficiency, and adherence to timelines and budgets.
Key Responsibilities
🎯 Leadership & Study Oversight
Serve as Lead Statistical Programmer on assigned studies.
Oversee end-to-end programming activities including:
Resource estimation
Budget tracking
Timelines & deliverable management
Cross-functional coordination with Biostatistics, Data Management, and other departments
Client communication and updates
💻 Programming & Development
Develop and maintain SAS® programs for:
SDTM (Study Data Tabulation Model) datasets
ADaM (Analysis Data Model) datasets
TFLs (Tables, Listings, and Figures)
Perform Quality Control (QC) reviews of SDTMs, ADaMs, and TFLs to ensure accuracy and compliance.
📑 Regulatory Submission Deliverables
Generate and maintain:
Define.xml / Define.pdf
Analysis Results Metadata (ARM)
Annotated CRFs (aCRFs)
Reviewer’s Guides (SDTM & ADaM)
Ensure all outputs meet CDISC and regulatory submission requirements.
🧩 Standards & Specifications
Develop or lead the development of complex dataset specifications (SDTM & ADaM).
Contribute to enhancement and maintenance of Fortrea and Client Programming Standards.
Review Statistical Analysis Plans (SAPs) and TFL shells, providing programming perspective and recommendations.
👥 Mentorship & Training
Mentor junior programmers, ensuring adherence to departmental processes and industry standards.
Lead knowledge-sharing sessions and departmental presentations.
📈 Quality & Audits
Respond to Quality Assurance (QA) and Client Audits.
Support qualification audits and ensure compliance with internal SOPs and external regulatory expectations.
💡 Business Development & Process Improvement
Contribute to proposal development and bid defense meetings to support business growth.
Identify and recommend process improvements to enhance efficiency, quality, and productivity within programming operations.
🔄 Additional Responsibilities
Perform any other duties as assigned to meet project and organizational goals.
Minimum Qualifications
🎓 Education:
Bachelor’s Degree (preferred in Mathematics, Statistics, Computer Science, Life Sciences, Health Sciences, or related field).
Equivalent education and relevant work experience may be considered in lieu of formal degree.
🗣️ Language Proficiency:
English (Speaking, Reading, Writing): Required
Experience Requirements
✅ Minimum 6 years of SAS® programming experience in CRO or Pharmaceutical industry, or equivalent combination of education and experience.
✅ Proven experience as Lead Statistical Programmer on complex clinical studies.
✅ Strong understanding of clinical trial lifecycle from setup to closeout.
✅ Deep knowledge of CDISC standards, including:
SDTM
ADaM
Define.xml
Reviewer’s Guide
Submission standards
Core Competencies
Advanced SAS® programming skills
Strong leadership and mentoring abilities
Comprehensive CDISC and regulatory submission knowledge
Excellent communication and cross-functional collaboration
Detail-oriented with focus on data integrity and quality
Capable of managing multiple studies simultaneously
Work Environment & Travel
🏢 Work Setup: Office-based or Home-based (as per Line Manager direction)
✈️ Travel Requirements:
Yes – Local, Domestic, Regional, Global
Time Allocation: ~5%
Overnight Travel: Up to 100% of travel time
Purpose: Client meetings, training sessions, and project reviews
Equal Opportunity Statement
We are an Equal Opportunity Employer and committed to providing reasonable accommodations as required.
📎 Learn more about our EEO & Accommodation Policy [here].
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