About Syneos Health
Syneos Health® is a fully integrated life sciences services organization that accelerates customer success 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 emphasis on career growth and development
Inclusive and collaborative environment
Purpose-driven mission: “Driven to Deliver”
Role Overview
Position: Senior Statistical Programmer (Clinical Pharmacology)
Location: Hyderabad, India (Hybrid)
This role focuses on 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 custom programs using SAS or similar tools
Generate:
Summary tables
Data listings
Graphs
Derived datasets
Follow Statistical Analysis Plans (SAP) and programming specifications
2. Data Standards & Deliverables
Work with:
ADaM datasets
SDTM datasets
TFLs (Tables, Figures, Listings)
Ensure outputs meet quality, regulatory, and sponsor requirements
3. Validation & Quality Control
Perform validation programming
Identify and resolve discrepancies
Ensure adherence to:
SOPs and Work Instructions (WIs)
Regulatory guidelines (e.g., ICH)
4. Project & Timeline Management
Manage multiple studies simultaneously
Prioritize tasks and adapt to changing timelines
Provide accurate effort estimates and meet deadlines
Anticipate programming challenges and propose solutions
5. Documentation & Inspection Readiness
Maintain:
Complete project documentation
Testing and quality control records
Ensure audit and inspection readiness
6. Leadership & Oversight
Act as Lead Statistical Programmer
Direct and monitor programming activities of team members
Review:
Statistical Analysis Plans
Programming specifications
Annotated CRFs
Database designs
Provide feedback to improve efficiency and reduce rework
7. Collaboration & Communication
Work with:
Biostatisticians
Programmers
Cross-functional teams
Participate in:
Sponsor meetings
Kickoff meetings
Bid defense meetings
Communicate progress, risks, and issues effectively
8. Training & Mentoring
Mentor junior programmers
Develop and deliver training materials
Support onboarding and skill development
9. Additional Responsibilities
Conduct internal meetings and ensure follow-ups
Support business initiatives and project needs
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
Hands-on 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 frameworks (ICH, GCP)
Core Competencies
Strong analytical and problem-solving skills
Excellent written and verbal communication
Ability to manage multiple priorities
Leadership and mentoring capabilities
High attention to detail and quality
Role Summary
The Senior Statistical Programmer is responsible for:
Developing and validating clinical trial datasets and outputs
Leading programming activities across studies
Ensuring regulatory compliance, quality, and timely delivery
Supporting clinical pharmacology and early-phase research
Work Environment
Hybrid work model (Hyderabad)
Collaborative global team
Opportunities for career advancement and leadership
Additional Information
Responsibilities may evolve based on business needs
Equivalent qualifications and experience may be considered
Commitment 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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