About Syneos Health
Syneos Health® is a fully integrated life sciences services organization that supports customers across the drug development and commercialization lifecycle.
Key Highlights
25,000+ employees globally
Supported:
94% of novel FDA-approved drugs
95% of EMA-authorized products
Extensive experience across global clinical trials
Work Culture
Strong focus on career growth and development
Inclusive and collaborative work environment
Purpose-driven approach: “Driven to Deliver”
Role Overview
Position: Senior Statistical Programmer (Clinical Pharmacology)
Location: Gurugram, India (Hybrid)
This role involves leading statistical programming activities for clinical pharmacology studies, including development of datasets, tables, listings, and figures (TFLs), while ensuring compliance with regulatory standards and project timelines.
Key Responsibilities
1. Statistical Programming & Analysis
Develop programs using SAS or other software
Generate:
Summary tables
Data listings
Graphs
Derived datasets
Follow Statistical Analysis Plans (SAP) and programming specifications
2. Data Standards & Deliverables
Work on:
ADaM datasets
SDTM datasets
TFLs (Tables, Figures, Listings)
Ensure outputs meet quality and regulatory standards
3. Validation & Quality Control
Perform validation programming
Identify and resolve discrepancies
Ensure compliance with:
SOPs (Standard Operating Procedures)
WIs (Work Instructions)
Regulatory guidelines (e.g., ICH)
4. Project & Timeline Management
Manage multiple projects simultaneously
Plan and prioritize tasks based on deadlines
Adapt to changing timelines and priorities
Provide accurate effort estimates for programming activities
5. Documentation & Inspection Readiness
Maintain:
Complete project documentation
Testing and validation records
Ensure audit and inspection readiness
6. Leadership & Mentoring
Act as Lead Statistical Programmer
Guide and oversee junior programmers
Review:
Statistical Analysis Plans
Programming specifications
Annotated CRFs
Provide feedback to improve efficiency and quality
7. Collaboration & Communication
Work closely with:
Biostatisticians
Programmers
Cross-functional teams
Participate in:
Sponsor meetings
Kickoff meetings
Bid defense meetings
Communicate progress, risks, and issues effectively
8. Training & Knowledge Sharing
Mentor junior team members
Develop and deliver training materials
Support onboarding and skill development
9. Additional Responsibilities
Conduct and lead internal meetings
Ensure timely follow-up on action items
Support business needs and additional assigned tasks
Minimal travel as required
Qualifications
Education
Bachelor’s degree in a scientific or statistical discipline (preferred)
Equivalent experience may be considered
Experience
5–8 years of statistical programming experience
Strong experience in:
End-to-end programming activities
Clinical trial environments
Experience with:
ADaM, SDTM, and TFL development
Exposure to:
Early phase studies
PK/PD (Clinical Pharmacology) trials (preferred)
Technical Skills
Advanced proficiency in SAS programming (or equivalent tools)
Strong understanding of clinical data standards
Knowledge of regulatory guidelines (ICH, GCP)
Core Competencies
Strong analytical and problem-solving skills
Excellent written and verbal communication
Ability to manage multiple priorities
Leadership and mentoring capabilities
Attention to detail and quality focus
Role Summary
The Senior Statistical Programmer is responsible for:
Developing and validating clinical trial datasets and outputs
Leading programming activities across studies
Ensuring compliance, quality, and timely delivery
Supporting clinical pharmacology and early-phase research
Work Environment
Hybrid work model (Gurugram)
Collaborative global team setting
Opportunities for leadership and career advancement
Additional Information
Responsibilities may evolve based on business needs
Equivalent qualifications and experience will be considered
Committed to diversity, inclusion, and equal opportunity
Provides reasonable accommodations where applicable
Call to Action
Apply now or join the Talent Network for future opportunities
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