Principal Biostatistician
Company: Syneos Health
Location: IND–Hyderabad (Hybrid)
Job ID: 25107517
Updated On: May 19, 2026
Company Overview
Syneos Health is a fully integrated life sciences services organization focused on accelerating drug development and commercialization. The company collaborates with pharmaceutical innovators to deliver clinical research and development solutions across the product lifecycle.
Key focus areas:
Clinical development support
Drug development consulting
Full-service and Functional Service Provider (FSP) models
Global clinical trials and regulatory support
Role Summary
The Principal Biostatistician is a senior-level statistical leadership role responsible for:
Leading biostatistics activities across clinical studies or programs
Acting as the primary statistical contact for sponsors
Providing advanced statistical expertise in study design, analysis, and regulatory submissions
Supporting cross-functional clinical development teams
Key Responsibilities
1. Leadership & Mentoring
Serve as a departmental expert in biostatistics
Mentor junior biostatisticians and support skill development
Conduct training sessions and develop training materials
Review and guide statistical work produced by team members
2. Study Design & Statistical Planning
Lead or contribute to protocol development from a statistical perspective
Develop and review Statistical Analysis Plans (SAPs)
Create mock tables, listings, and figures (TLFs)
Provide input into randomization and study design
3. Data Review & Quality Oversight
Review CRFs, database structures, and study documentation
Ensure data collection aligns with protocol requirements
Oversee quality control and validation of statistical outputs
Ensure compliance with SAP and regulatory standards
4. Statistical Programming & Deliverables
Review programming specifications for analysis datasets and outputs
Provide SAS programming support when needed
Ensure accuracy of tables, listings, and figures
5. Project & Team Management
Lead or manage multiple complex clinical projects
Monitor timelines, milestones, and deliverables
Identify and escalate out-of-scope work
Coordinate workload across studies and teams
6. Regulatory & Compliance Support
Follow SOPs, work instructions, and regulatory guidelines (e.g., ICH)
Support regulatory submissions and agency interactions
Contribute to DSMB/DMC activities when required
7. Stakeholder Collaboration
Act as biostatistics representative in project teams
Communicate with sponsors and cross-functional teams
Contribute to internal meetings and decision-making discussions
8. Business Development Support
Contribute to proposals and study budgets
Participate in bid defense meetings
Provide statistical input during client engagements
9. Documentation & Inspection Readiness
Maintain complete and audit-ready study documentation
Ensure proper version control and traceability of analyses
Required Skills & Competencies
Advanced expertise in biostatistics and clinical trial design
Strong knowledge of SAS or similar statistical software
Experience in SAP development and regulatory submissions
Ability to lead projects and mentor teams
Strong communication and stakeholder management skills
Understanding of clinical research regulations (ICH guidelines, etc.)
Work Environment
Hybrid work model (Hyderabad location)
Cross-functional global project teams
High-complexity, fast-paced clinical research environment
Career Impact
Opportunity to work on global clinical trials
Exposure to regulatory submissions (FDA/EMA)
Leadership role influencing drug development decisions
Contribution to healthcare innovation and patient outcomes
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