📊 Principal Statistical Programmer
Locations: Available in 3 Locations
Category: Clinical
Job ID: 25189
Company: Fortrea
🎯 Role Summary
The Principal Statistical Programmer serves as the Lead Programmer responsible for planning, executing, and overseeing all statistical programming activities across assigned studies. This includes resource estimation, budgeting, quality oversight, client interaction, and cross-functional collaboration.
The role demands expertise in SDTM, ADaM, TFLs, and regulatory submission deliverables, along with the ability to mentor junior programmers, ensure CDISC compliance, and contribute to process improvement initiatives.
🧠 Key Responsibilities
🔹 Leadership & Project Oversight
Serve as Lead Statistical Programmer on assigned studies.
Plan and manage all programming activities, including budgeting, timelines, quality control, and resource allocation.
Coordinate effectively with cross-functional departments and client stakeholders.
Participate in proposal development and bid defense meetings to support business growth.
🔹 Programming & Deliverables
Develop and maintain SAS® programs to produce SDTM, ADaM datasets, and TFLs (Tables, Listings, Figures).
Perform QC checks on all deliverables to ensure accuracy and compliance.
Generate Define XML/PDF, Analysis Results Metadata (ARM), aCRFs, and Reviewer’s Guides.
Lead development of complex specifications for SDTMs and ADaMs and contribute to Fortrea and client standards.
🔹 Technical & Process Excellence
Review Statistical Analysis Plans (SAPs) and TFL shells from a programming perspective.
Advise statisticians and study teams on complex TFL design and implementation.
Ensure deliverables meet CDISC, FDA, and global submission standards.
Identify and implement process improvements to enhance efficiency, quality, and productivity.
🔹 Mentorship & Knowledge Sharing
Mentor and train junior programmers on SDTM, ADaM, and TFL development best practices.
Present and share programming knowledge during team meetings and departmental sessions.
🔹 Quality & Compliance
Support QA and client audits, including qualification audits.
Maintain adherence to Fortrea’s SOPs, industry regulations, and sponsor requirements.
🎓 Qualifications
📘 Education
Bachelor’s Degree (preferred in Mathematics, Statistics, Computing, Life Science, Health Science, or related field).
Equivalent combination of education and experience may be considered in lieu of formal degree.
🧾 Language Skills
Speaking: English (Required)
Writing/Reading: English (Required)
💼 Experience Requirements
6+ years of SAS® programming experience in a CRO or Pharmaceutical industry.
Proven track record as Lead Statistical Programmer on complex clinical studies.
Comprehensive understanding of clinical trial processes, from study setup to closeout.
Strong cross-functional knowledge of Biostatistics, Clinical Data Management, and related functions.
Deep expertise in CDISC standards (SDTM, ADaM, Define.xml, Reviewer’s Guide).
🌍 Work Environment
Work Setup: Office-based or home-based (as per line manager approval).
Collaboration: Cross-functional and client-facing role.
✈️ Travel Requirements
Frequency: ~5% of total time.
Overnight Travel: Up to 100% of travel time.
Purpose: Client meetings, trainings, and business reviews.
⚖️ Equal Employment Opportunity (EEO)
Fortrea is committed to providing equal employment opportunities and accommodating applicants with disabilities.
🔗 Learn more: EEO & Accommodations Information
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