Job Title
Programming Lead (Lead Statistical Programmer)
Company
Fortrea
Location
Bangalore, India
Employment Type
Full-time
Job Overview
This is a lead-level statistical programming role focused on managing end-to-end programming activities for clinical trials. You will oversee SAS programming deliverables, ensure high-quality statistical outputs, manage timelines and budgets, and guide junior programmers.
Key Responsibilities
1. Study-Level Programming Leadership
Act as Lead Statistical Programmer for clinical studies
Plan and manage all programming activities for assigned studies
Ensure delivery within:
Budget
Timelines
Quality standards
2. SAS Programming & Clinical Data Standards
Develop and maintain SAS programs for:
SDTM datasets
ADaM datasets
Tables, Listings, and Figures (TFLs)
Perform QC of SDTM, ADaM, and TFL outputs
Ensure compliance with CDISC standards
3. Regulatory & Submission Support
Create submission-ready deliverables:
Define XML / Define PDFs
Analysis Results Metadata (ARM)
Annotated Case Report Forms (aCRFs)
Review guides
Support regulatory submission requirements
4. Study Design & Specification Review
Develop SDTM and ADaM specifications
Review Statistical Analysis Plans (SAPs)
Review TFL shells from programming perspective
5. Leadership & Mentoring
Mentor junior statistical programmers
Share technical knowledge in team meetings
Provide guidance on CDISC implementation and programming best practices
6. Quality & Compliance
Respond to audits (QA and client audits)
Support inspection readiness
Identify process improvements to enhance quality and efficiency
7. Stakeholder Collaboration
Interact with clients and cross-functional teams
Coordinate with other departments (biostatistics, clinical, data management)
Present updates and technical insights
Required Qualifications
Bachelor’s degree in:
Mathematics
Statistics
Computer Science
Life Sciences
Health Sciences
Or related fields
Equivalent experience may also be considered
Required Experience
Minimum 5 years SAS programming experience
Experience in:
CRO (Clinical Research Organization) or pharmaceutical industry
Clinical trial data standards and submissions
Required Skills
Technical Skills
Strong SAS programming expertise
CDISC standards knowledge (SDTM, ADaM)
Clinical trial data analysis
Submission deliverables (Define.xml, TFLs, etc.)
Core Competencies
Leadership and team management
Strong analytical thinking
Attention to detail
Ability to manage multiple studies
Problem-solving in complex datasets
Soft Skills
Strong communication skills (English)
Mentoring ability
Client interaction skills
Time and project management
Work Environment
Office or remote/hybrid setup
Client-facing role
May involve travel (~5%) for meetings and trainings
Role Summary (Simple Explanation)
This is a senior-level clinical statistical programming leadership role where you will:
Lead SAS programming teams
Manage clinical trial datasets and submissions
Ensure compliance with CDISC standards
Handle regulatory reporting outputs
Mentor junior programmers
Interact with clients and auditors
Key Insight
This is a senior role (5+ years experience)
Higher level than Statistical Programmer or RBQM Programmer
Strong pathway into:
Statistical Programming Manager
Biostatistics leadership roles
Clinical Data Science leadership
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