Job Overview
Position: Principal Biostatistician
Company: Syneos Health
Location: Hyderabad (Hybrid)
Job ID: 25107517
Updated: May 19, 2026
Department: Biostatistics / Clinical Solutions
Work Mode: Hybrid
About the Company
Syneos Health is a leading life sciences services organization focused on accelerating customer success across clinical development and commercialization.
Company highlights:
Supported 94% of novel FDA-approved drugs in the last 5 years
Worked on 95% of EMA-authorized products
Conducted 200+ studies across 73,000+ clinical sites worldwide
Role Summary
The Principal Biostatistician is a senior-level leadership role responsible for:
Leading statistical activities across multiple clinical studies
Acting as the primary sponsor contact for biostatistics
Supporting study design and protocol development
Overseeing statistical analysis deliverables
Mentoring biostatistics teams
Supporting regulatory submissions and integrated analyses
This role requires advanced expertise in clinical trial biostatistics, statistical methodologies, and sponsor-facing project leadership.
Key Responsibilities
Biostatistics Leadership
Serve as a statistical department resource
Mentor and train biostatisticians
Develop training plans and learning materials
Review work produced by other statisticians
Statistical Analysis Support
Support projects throughout the study lifecycle:
Protocol development
Statistical analysis planning
Data analysis
Clinical Study Reports (CSR)
Lead or oversee preparation of:
Statistical Analysis Plans (SAPs)
Tables, Listings, and Figures (TLFs)
Mock shells and displays
Study Design & Protocol Support
Provide statistical input for:
Study design
Endpoint selection
Protocol development
Randomization strategies
Support protocol-related statistical decisions
Programming & Dataset Oversight
Create or review:
Programming specifications
Analysis datasets
TLF specifications
Review:
SAS annotated CRFs
Database designs
Study documentation
Quality Control & Compliance
Conduct QC and validation reviews
Ensure outputs align with:
SAPs
Protocols
Regulatory standards
Maintain inspection readiness documentation
Follow:
SOPs
Work Instructions (WIs)
ICH guidelines
Project & Timeline Management
Manage multiple concurrent studies and priorities
Monitor study milestones and deliverables
Escalate out-of-scope activities
Communicate project risks and timeline concerns proactively
Sponsor & Cross-Functional Collaboration
Serve as primary sponsor contact for biostatistics activities
Collaborate with:
Statistical programmers
Clinical teams
Data management
Regulatory teams
Participate in sponsor meetings and project discussions
Regulatory & Submission Support
Lead or support:
Regulatory submissions
Integrated analyses
Agency responses
Attend regulatory meetings when required
DSMB / DMC Participation
Participate in:
Data Safety Monitoring Board (DSMB) activities
Data Monitoring Committee (DMC) activities
Support charter development and independent statistical reviews
Business Development Support
Contribute to:
Proposal development
Budget planning
Sponsor bid defense meetings
Required Qualifications
Educational Background
Typically requires advanced education in:
Biostatistics
Statistics
Mathematics
Life Sciences
Related quantitative disciplines
Required Skills & Expertise
Core Technical Expertise
Clinical trial biostatistics
Statistical analysis methodologies
Study design and protocol support
Randomization methodologies
Regulatory statistical requirements
Statistical Programming Knowledge
SAS programming understanding
Dataset and TLF review
Programming specification review
Regulatory Knowledge
ICH Guidelines
GCP compliance
Regulatory submission processes
Preferred Competencies
Integrated analysis experience
Submission project leadership
DSMB/DMC involvement
Sponsor-facing consultancy experience
Team leadership and mentoring
Cross-functional project coordination
Soft Skills
Excellent communication and presentation skills
Leadership and mentoring abilities
Strong analytical and problem-solving skills
Ability to manage multiple complex projects
Strong organizational and stakeholder management skills
Work Environment & Culture
Why Join Syneos Health?
Career development and progression opportunities
Technical and therapeutic-area training
Inclusive and collaborative work culture
Global project exposure
Recognition and rewards programs
Functional Areas Covered
Biostatistics
Clinical Trial Design
Statistical Analysis
Regulatory Submissions
Statistical Programming Oversight
Clinical Data Analytics
Seniority & Impact
Role Level
Senior principal-level individual contributor with:
Strategic influence
Sponsor-facing leadership
Cross-study responsibility
Organizational Impact
The role contributes directly to:
Clinical trial quality
Statistical integrity
Regulatory submission success
Sponsor relationship management
Ideal Candidate Profile
The ideal candidate should:
Have strong expertise in clinical trial biostatistics
Lead complex studies independently
Manage sponsor communications confidently
Mentor junior statisticians effectively
Understand regulatory expectations deeply
Deliver high-quality statistical outputs within timelines
Employment Notes
Additional responsibilities may be assigned as required
Equivalent qualifications and experience may be considered
Syneos Health is an equal opportunity employer
Reasonable accommodations are available where appropriate
Application
Apply via:
Syneos Health Careers
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