Job Title: Senior Statistical Programmer
Company: Syneos Health
Skill Area: Statistical Programming – Clinical Data Analysis
Role Overview:
The Senior Statistical Programmer is responsible for developing and validating statistical programs to generate clinical trial outputs such as tables, listings, and graphs. The role ensures high-quality data analysis, supports biostatistics teams, and contributes to regulatory submissions.
About the Company:
Syneos Health is a fully integrated life sciences organization that supports drug development and commercialization. It partners with global innovators to deliver clinical, regulatory, and safety solutions.
Key Responsibilities:
1. Statistical Programming
Develop programs using SAS or other statistical software
Generate:
Summary tables
Data listings
Graphs
Derived datasets
Follow Statistical Analysis Plan (SAP) and programming specifications
2. Validation & Quality Control
Perform validation programming to ensure accuracy
Identify and resolve discrepancies
Ensure outputs meet quality and regulatory standards
3. Documentation & Compliance
Maintain complete and organized project documentation
Ensure inspection readiness
Follow SOPs, Work Instructions (WIs), and ICH guidelines
4. Project & Time Management
Manage multiple projects simultaneously
Prioritize tasks and meet deadlines
Adapt to timeline or priority changes efficiently
5. Dataset & Specification Development
Develop dataset specifications based on study requirements
Define variables clearly for analysis and reporting
Anticipate and resolve programming challenges
6. Leadership & Team Coordination
Act as Lead Statistical Programmer
Guide and monitor junior programmers
Review:
Statistical Analysis Plans (SAP)
Annotated CRFs
Programming specifications
7. Meetings & Stakeholder Communication
Participate in:
Internal project meetings
Sponsor meetings
Kick-off and bid defense meetings
Provide updates on progress and issues
Contribute ideas and solutions
8. Training & Mentorship
Mentor junior team members
Develop and deliver training materials
Review team outputs and provide feedback
9. Additional Responsibilities
Ensure timely delivery of programming outputs
Support business and project needs
Occasional travel may be required
Educational Qualifications:
Bachelor’s degree in a scientific or statistical discipline
Equivalent experience may be considered
Experience Required:
Extensive experience in SAS programming
Experience in clinical trial environment preferred
Required Skills & Competencies:
Strong knowledge of SAS or statistical programming tools
Understanding of clinical trial data and analysis
Attention to detail and accuracy
Problem-solving and analytical skills
Excellent communication skills
Ability to manage multiple projects
Work Environment:
Fast-paced, project-driven environment
Collaborative team structure
Interaction with global stakeholders
Additional Information:
Role may include minimal travel
Responsibilities may evolve based on project needs
Equal opportunity employer
Compliance with global employment and regulatory standards
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