Job Title:
Principal Statistical Programmer
Company:
Fortrea
🌐 www.fortrea.com
Job Details:
Job ID: 25189
Category: Clinical
Locations: Available in 3 locations
Work Environment: Office or Home-based (flexible)
Travel Required: Yes (up to 5%); includes client meetings and trainings (overnight travel may be required)
Job Overview:
As a Principal Statistical Programmer, you will serve as the Lead Programmer for clinical trials. This role involves planning, execution, and oversight of programming activities, including dataset development (SDTM/ADaM), TFL generation, regulatory submissions, and team mentoring.
Key Responsibilities:
🎯 Study Management & Leadership
Serve as Lead Statistical Programmer on assigned clinical studies.
Plan and oversee all programming activities including resource estimation, budgeting, timelines, quality, and cross-functional collaboration.
Interact with internal departments and external clients to ensure smooth study execution.
💻 SAS Programming & Data Standards
Develop and maintain SAS® programs for:
SDTM and ADaM datasets
Tables, Figures, and Listings (TFLs)
Perform quality control (QC) of SDTM, ADaMs, and TFLs.
📑 Regulatory Document Support
Produce and manage:
Define.xml/Define.pdf
Analysis Results Metadata (ARM)
Annotated CRFs (aCRFs)
Reviewer’s Guides for both SDTM and ADaM datasets
🧾 Documentation & Standards Development
Develop complex specifications for SDTMs and ADaMs.
Contribute to the development and enhancement of internal and client-specific data standards.
Review Statistical Analysis Plans (SAPs) and TFL shells from a programming perspective.
👥 Team Mentorship & Collaboration
Mentor junior and less experienced programmers in:
SDTM/ADaM/TFL best practices
Fortrea’s programming processes and standards
Present and share knowledge at departmental meetings.
🔍 Audit & Client Interaction
Respond to QA and client audits; support qualification audits.
Contribute to proposals and participate in bid defense meetings to win new business.
🛠 Process Improvement
Proactively identify opportunities to improve programming efficiency, quality, and productivity.
🔁 Additional Responsibilities
Perform all other duties as assigned by management.
Required Qualifications:
🎓 Education:
Bachelor's degree in Mathematics, Statistics, Computer Science, Life Sciences, Health Sciences, or a related field.
Relevant work experience may be considered in lieu of a formal degree.
🗣 Language Skills:
Speaking: English (Required)
Writing/Reading: English (Required)
Experience Requirements:
Minimum 6 years of SAS® programming experience in the CRO or pharmaceutical industry.
Proven experience as a Lead Statistical Programmer on complex clinical studies.
Strong understanding of:
Clinical trial processes from setup to close-out
Biostatistics and Data Management roles
CDISC standards (SDTM, ADaM, define.xml, Reviewer’s Guide)
Familiarity with regulatory submission requirements (e.g., FDA, EMA).
Preferred Skills & Attributes:
Excellent communication and leadership skills.
Strong organizational and problem-solving ability.
Ability to work independently and collaboratively.
Detail-oriented with a commitment to data quality and integrity.
Physical Demands / Work Environment:
Work Setting: Office-based or remote
Travel:
Required: Yes (approximately 5%)
Purpose: Client meetings, training sessions
Overnight Stays: May be up to 100% of travel
About Fortrea:
Fortrea is a leading global Contract Research Organization (CRO) with decades of clinical development expertise. Operating in over 100 countries, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to accelerate therapies across 20+ therapeutic areas.
Our Values – Fortrea FOUR:
Forward Together
Own It
Uphold Integrity
Respect People
Join us in transforming clinical trials and making a meaningful global impact.
Equal Opportunity Employer:
Fortrea is an EEO employer and is committed to diversity, inclusion, and providing accommodation as needed.
🔗 Learn more about EEO & Accommodations
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