Fortrea – Principal Statistical Programmer | Clinical Trials | Multiple Locations
Company: Fortrea
Location: Multiple Locations (Global / India-based roles available)
Job Type: Full-Time
Work Mode: Office-based / Home-based (Hybrid flexibility)
Experience: 6+ Years (Statistical Programming in Clinical Research)
Qualification: Bachelor’s Degree (Statistics, Mathematics, Life Sciences, Computing, or related field)
Compensation: Not disclosed in the job description
Clinical SAS programming and biostatistics jobs are among the highest-paying and most in-demand roles in pharma, especially positions focused on CDISC standards, SDTM/ADaM datasets, and regulatory submissions.
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Job Summary
Fortrea is hiring a Principal Statistical Programmer to lead programming activities across clinical trials, ensuring high-quality statistical analysis, regulatory-compliant datasets, and submission-ready outputs. This role plays a critical leadership position in biostatistics, clinical data analysis, and regulatory submissions.
You will act as a Lead Statistical Programmer, overseeing end-to-end programming deliverables including SDTM, ADaM datasets, Tables Listings Figures (TFLs), and CDISC compliance, while collaborating with cross-functional teams.
This role is ideal for professionals aiming to grow in:
Statistical Programming (SAS)
Biostatistics & Clinical Data Science
Clinical Trial Analytics
Regulatory Submissions
Key Responsibilities
Statistical Programming Leadership
Act as Lead Statistical Programmer on clinical studies
Plan, manage, and oversee programming activities across study lifecycle
Ensure delivery within timelines, budget, and quality standards
CDISC & Dataset Development
Develop and maintain:
SDTM (Study Data Tabulation Model) datasets
ADaM (Analysis Data Model) datasets
Tables, Listings, and Figures (TFLs)
Perform quality control (QC) of datasets and outputs
Regulatory Submission Support
Produce and manage:
Define.xml / Define PDF
Analysis Results Metadata (ARM)
Annotated CRFs (aCRFs)
Reviewer’s Guides
Ensure compliance with global regulatory submission standards
Study Design & Analysis Support
Review Statistical Analysis Plans (SAPs) and TFL shells
Contribute to development of complex TFL specifications
Provide programming insights during study setup and execution
Team Leadership & Mentorship
Mentor junior programmers on CDISC standards and processes
Share knowledge and best practices within the team
Support team capability development
Client Interaction & Business Support
Collaborate with sponsors, biostatisticians, and clinical teams
Participate in audits, QA activities, and client meetings
Support proposal development and bid defense activities
Process Improvement
Identify opportunities to improve efficiency, quality, and productivity
Contribute to development of internal and client programming standards
Required Skills & Qualifications
Bachelor’s degree in Statistics, Mathematics, Life Sciences, or related field
6+ years of SAS programming experience in CRO/Pharma industry
Strong expertise in:
CDISC standards (SDTM, ADaM)
TFL generation and statistical reporting
Experience as Lead Statistical Programmer on complex studies
Knowledge of:
Clinical trial lifecycle
Biostatistics and Clinical Data Management
Regulatory submission requirements
Strong problem-solving, analytical, and communication skills
Fluent English (written and verbal)
Preferred Skills (High SEO Keywords):
SAS Programming (Base SAS, SAS Macros)
Define.xml, Reviewer’s Guide, ARM
Clinical Data Analysis & Visualization
Regulatory Submissions (FDA, EMA)
Biostatistics & Statistical Modeling
Project Management in Clinical Trials
Perks & Benefits
Flexible work environment (office/home-based options)
Opportunity to lead global clinical trial programming projects
Exposure to regulatory submissions and advanced analytics
Career growth into senior biostatistics and data science roles
Work with a leading global CRO
About the Company
Fortrea is a global Contract Research Organization specializing in clinical development, data science, and regulatory services. The company supports pharmaceutical and biotech organizations in accelerating drug development with high-quality clinical data and analytics.
Why This Role is High-Value in Pharma Careers
The Principal Statistical Programmer role is a cornerstone in clinical research and drug development. With increasing regulatory focus on data quality and compliance, professionals skilled in SAS programming and CDISC standards are highly sought after globally.
This role provides exposure to:
Global regulatory submissions (FDA, EMA)
Advanced clinical trial data analytics
Cross-functional collaboration with biostatistics and clinical teams
Career progression includes:
Lead Biostatistician
Statistical Programming Manager
Clinical Data Science Lead
Director – Biostatistics
Application Process
Apply via Fortrea careers portal
Highlight experience in:
SAS Programming
CDISC (SDTM, ADaM)
Clinical Trials & Regulatory Submissions
Use strong keywords:
Statistical Programming
TFLs
Clinical Data
Biostatistics
Call to Action
If you want to lead high-impact clinical trial programming and regulatory submissions, this is your opportunity.
Apply now and accelerate your career in biostatistics and clinical data science with Fortrea 🚀
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