Principal Biostatistician – Structured Job Format
Job Overview
Position: Principal Biostatistician
Company: Syneos Health
Location: IND-Remote
Job ID: 25107517
Updated: May 19, 2026
Department: Biostatistics / Clinical Solutions
Work Mode: Remote
About the Company
Syneos Health is a fully integrated life sciences services organization supporting pharmaceutical and biotechnology companies throughout the drug development lifecycle.
Company highlights:
Supported 94% of novel FDA-approved drugs over the past 5 years
Worked on 95% of EMA-authorized products
Conducted 200+ studies across 73,000+ clinical sites globally
Role Summary
The Principal Biostatistician is a senior-level leadership role responsible for:
Leading biostatistics activities across studies and programs
Acting as the primary sponsor contact for biostatistics
Supporting protocol development and statistical strategy
Managing statistical analysis deliverables
Mentoring and guiding biostatistics teams
Supporting regulatory submissions and complex analyses
The role requires strong expertise in clinical trial biostatistics, study design, statistical analysis planning, and regulatory compliance.
Key Responsibilities
Biostatistics Leadership
Serve as a departmental statistical expert
Mentor and train biostatisticians
Develop training plans and educational materials
Review and oversee work produced by team members
Statistical Analysis & Study Support
Support studies throughout the full lifecycle:
Protocol development
Statistical analysis
Clinical Study Reports (CSR)
Lead or oversee:
Statistical Analysis Plans (SAPs)
Mock tables, listings, and figures
Randomization schedules
Protocol & Study Design Support
Provide statistical input for:
Protocol development
Study design considerations
Endpoint definitions
Analysis methodologies
Programming & Specifications
Create or review:
Programming specifications
Analysis datasets
Tables, listings, and figures (TLFs)
Review:
SAS annotated CRFs
Database design
Study documentation
Quality Control & Compliance
Conduct QC and validation reviews
Ensure outputs align with:
SAPs
Specifications
Regulatory standards
Follow:
SOPs
Work Instructions (WIs)
ICH guidelines
Project & Timeline Management
Manage multiple projects and competing priorities
Monitor milestones and deliverables
Identify and escalate out-of-scope activities
Communicate timeline risks proactively
Sponsor & Cross-Functional Collaboration
Act as primary sponsor contact for biostatistics activities
Collaborate with:
Statistical programmers
Clinical teams
Data management
Regulatory teams
Participate in internal and sponsor meetings
Regulatory & Submission Support
Support:
Regulatory submissions
Integrated analyses
Agency responses
Participate in regulatory meetings as needed
DSMB / DMC Support
Participate in:
Data Safety Monitoring Board (DSMB) activities
Data Monitoring Committee (DMC) activities
Support:
Charter development
Independent statistical review
Business Development
Contribute to:
Proposal development
Budget preparation
Bid defense meetings
Required Qualifications
Educational Background
Typically requires advanced education in:
Biostatistics
Statistics
Mathematics
Life Sciences
Related quantitative discipline
Required Skills & Expertise
Core Technical Expertise
Clinical trial biostatistics
Statistical analysis planning
Study design methodology
Randomization methodology
Regulatory statistical standards
Statistical Programming Knowledge
SAS programming understanding
TLF review and validation
Dataset specification review
Regulatory Knowledge
ICH Guidelines
GCP standards
Regulatory submission processes
Preferred Competencies
Integrated analyses experience
Submission project leadership
DSMB/DMC participation
Sponsor-facing consulting experience
Team mentoring and leadership
Cross-functional project management
Soft Skills
Excellent communication and presentation skills
Leadership and mentoring ability
Strong analytical and problem-solving mindset
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
Collaborative global work culture
Inclusive and diverse workplace
Recognition and rewards programs
Exposure to global clinical development programs
Functional Areas Covered
Biostatistics
Clinical Trial Design
Statistical Analysis
Regulatory Submissions
Statistical Programming Oversight
Clinical Data Analytics
Seniority & Impact
Role Level
Senior-level principal individual contributor with:
Strategic influence
Sponsor-facing responsibilities
Cross-study leadership
Business Impact
The role directly contributes to:
Clinical trial success
Regulatory submission quality
Statistical integrity
Sponsor relationship management
Ideal Candidate Profile
The ideal candidate should:
Have deep expertise in clinical trial biostatistics
Lead complex studies and statistical deliverables independently
Manage sponsor communications confidently
Mentor junior statisticians effectively
Understand regulatory expectations thoroughly
Balance scientific rigor with operational delivery
Employment Notes
Additional responsibilities may be assigned as needed
Equivalent qualifications and experience may be considered
Syneos Health is an equal opportunity employer
Reasonable accommodations are available where appropriate
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Remote, India | Siliguri |Illinois :
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Concord | Lumberton | North Carolina |Michigan :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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