Principal Biostatistician – Job Summary
Company: Syneos Health
Job Title: Principal Biostatistician
Job ID: 25107517
Location: Hyderabad, India (Hybrid)
Department: Biostatistics
Experience Level: Senior / Principal Level
Employment Type: Full-Time
Role Overview
The Principal Biostatistician serves as the lead statistical expert for clinical development programs and acts as the primary biostatistics contact for sponsors. This role is responsible for providing statistical leadership throughout the clinical trial lifecycle, from protocol development to Clinical Study Reports (CSR), while managing multiple studies, mentoring biostatisticians, supporting regulatory submissions, and contributing to business development activities.
The position requires expertise in study design, statistical methodologies, SAP development, regulatory interactions, and cross-functional leadership.
Key Responsibilities
Statistical Leadership
Serve as the lead biostatistician for assigned studies and programs.
Act as the primary statistical contact for sponsors.
Provide expert statistical consultation on:
Clinical trial design
Protocol development
Statistical methodologies
Regulatory requirements
Support multiple studies and integrated analyses simultaneously.
Study Design & Statistical Planning
Develop and review:
Clinical study protocols
Statistical Analysis Plans (SAPs)
Randomization schedules
Statistical methodologies
Design mock tables, listings, and figures (TLFs).
Provide statistical input for Clinical Study Reports (CSRs).
Analysis & Deliverables
Oversee statistical analyses throughout the study lifecycle.
Ensure statistical outputs align with protocol objectives and SAP requirements.
Review:
Analysis datasets
Tables, Listings, and Figures (TLFs)
Programming specifications
Statistical outputs
Support integrated analyses and regulatory submissions.
Programming & Data Review
Review:
Annotated CRFs
Database designs
Analysis specifications
SAS programming deliverables
Provide statistical programming support when required.
Ensure data quality and protocol compliance.
Quality Control & Compliance
Conduct independent QC review of statistical deliverables.
Ensure compliance with:
ICH Guidelines
Regulatory Requirements
SOPs
Work Instructions (WIs)
Maintain inspection-ready documentation and validation records.
Regulatory & Safety Committees
Support regulatory agency interactions.
Participate in:
FDA/EMA submission activities
Regulatory response preparation
DSMB (Data Safety Monitoring Board)
DMC (Data Monitoring Committee)
May serve as an independent or voting statistician on safety monitoring committees.
Team Leadership & Mentoring
Mentor and develop junior and mid-level biostatisticians.
Conduct statistical training programs.
Review work produced by team members.
Support capability development and succession planning.
Project & Resource Management
Manage timelines and milestones across multiple studies.
Identify project risks and escalate issues proactively.
Track study progress and ensure timely delivery.
Manage workload and resource planning.
Business Development
Contribute to:
Proposal development
Budget preparation
Bid defense meetings
Sponsor presentations
Provide statistical expertise during business acquisition activities.
Required Qualifications
Education
Master's Degree or PhD in:
Biostatistics
Statistics
Mathematics
Applied Statistics
Related Quantitative Discipline
Experience
Typically 10+ years of Biostatistics experience in:
Pharmaceutical Industry
CRO Environment
Clinical Research Organizations
Extensive experience leading global clinical studies.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Basel | Zurich |Serbia :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Renfrew | Mississauga | Uxbridge | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Jakarta |East Java :
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Japan | Saitama |Tokyo :
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Turku |Remote Korea :
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Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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