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 global clinical trial experience
Work Culture
Strong focus on employee development and career growth
Inclusive and collaborative workplace
Purpose-driven mission: “Driven to Deliver”
Role Overview
Position: Principal Statistical Programmer (Clinical Pharmacology)
Location: Gurugram, India (Hybrid)
This is a senior-level role responsible for leading complex statistical programming activities, acting as a subject matter expert (SME), and driving high-quality deliverables across clinical pharmacology studies.
Key Responsibilities
1. Statistical Programming & Deliverables
Develop custom programs using SAS or equivalent tools
Generate:
Tables, Listings, and Figures (TFLs)
Derived datasets
Follow Statistical Analysis Plans (SAP) and programming specifications
Ensure outputs meet quality and regulatory standards
2. Data Standards & Compliance
Apply and oversee:
CDISC standards (SDTM, ADaM)
Regulatory submission requirements
Perform compliance reviews for:
SDTM/ADaM datasets
DEFINE.XML and regulatory deliverables
Ensure adherence to SOPs, WIs, and ICH guidelines
3. Validation & Quality Control
Perform validation programming
Resolve discrepancies with cross-functional teams
Maintain high standards of data accuracy and integrity
4. Project & Delivery Management
Manage multiple complex/global projects
Ensure on-time delivery of programming deliverables
Define timelines and negotiate priorities
Identify risks and implement mitigation strategies
Provide regular status updates to management
5. Leadership & Team Oversight
Act as Lead Statistical Programmer
Direct and monitor activities of programming teams
Mentor and train junior programmers
Provide performance feedback and guidance
6. Technical Expertise & Innovation
Serve as SME for:
CDISC standards
Regulatory submission requirements
Contribute to development of:
Programming tools and macros
Standardization processes
Support SOP and guideline development
7. Collaboration & Stakeholder Engagement
Participate in:
Sponsor meetings
Kickoff meetings
Bid defense meetings
Collaborate with:
Biostatistics teams
Cross-functional stakeholders
Provide expert input to improve study efficiency
8. Documentation & Inspection Readiness
Maintain:
Complete and accurate documentation
Testing and quality control records
Ensure readiness for audits and inspections
9. Training & Knowledge Sharing
Develop and deliver training programs
Guide teams on CDISC standards and best practices
Share updates on evolving regulatory and industry standards
10. Additional Responsibilities
Lead internal meetings and ensure follow-up actions
Support business initiatives and process improvements
Minimal travel as required
Qualifications
Education
Bachelor’s degree in a scientific or statistical discipline (preferred)
Equivalent experience may be considered
Experience
Extensive experience in statistical programming within clinical trials
Proven ability to lead complex and global projects
Strong experience in:
SAS programming
CDISC standards (SDTM, ADaM)
Experience with regulatory submissions (preferred)
Experience mentoring and training teams
Technical Skills
Advanced proficiency in SAS or equivalent programming tools
Deep understanding of:
Clinical trial data standards
Regulatory frameworks and submission requirements
Core Competencies
Strong leadership and mentoring abilities
Strategic thinking and problem-solving skills
Excellent communication and stakeholder management
High attention to detail and quality focus
Ability to manage multiple priorities and deadlines
Role Summary
The Principal Statistical Programmer is a senior technical leader responsible for:
Driving complex statistical programming deliverables
Acting as an SME for CDISC and regulatory standards
Leading teams and ensuring high-quality outputs
Supporting clinical pharmacology and regulatory submissions
Work Environment
Hybrid work model (Gurugram)
Collaborative, global team environment
Opportunities for leadership and career advancement
Additional Information
Responsibilities may evolve based on business needs
Equivalent qualifications and experience may 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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