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Principal Biostatistician

Syneos Health
0-2 years
Not Disclosed
Remote, India, India
10 May 22, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company

Syneos Health

Job Title

Principal Biostatistician

Job ID

  • 25107517

Location

  • India

  • IND-Remote

Updated On

  • May 19, 2026


Company Overview

Syneos Health is a global life sciences organization supporting pharmaceutical and biotechnology companies in drug development and commercialization. The company partners with innovators to accelerate clinical development and improve patient outcomes worldwide.


Role Summary

The Principal Biostatistician is a senior-level statistical leadership role responsible for:

  • Managing biostatistics activities across multiple clinical studies

  • Leading statistical strategy and analysis

  • Supporting protocol and study design

  • Managing sponsor interactions

  • Overseeing statistical deliverables throughout the clinical trial lifecycle

The role also serves as:

  • Primary sponsor contact for biostatistics matters

  • Statistical consultant for clinical programs

  • Subject matter expert in statistical methodology and trial design


Core Responsibilities

1. Statistical Leadership & Oversight

Project Leadership

  • Lead biostatistics support across multiple studies/programs

  • Oversee statistical deliverables from:

    • Protocol development

    • Statistical analysis

    • Clinical Study Reports (CSR)

Team Leadership

  • Mentor and train biostatistics staff

  • Conduct training sessions

  • Review work completed by junior biostatisticians

Cross-Functional Collaboration

Collaborate with:

  • Clinical teams

  • Statistical programmers

  • Data management teams

  • Sponsors

  • Regulatory stakeholders


2. Statistical Analysis & Study Support

Statistical Analysis Plans (SAPs)

  • Develop or oversee SAP preparation

  • Design mock shells for:

    • Tables

    • Listings

    • Figures (TLFs)

Protocol & Study Design

  • Support statistical input for protocol development

  • Review study documentation for:

    • Protocol compliance

    • Data capture quality

    • Analysis readiness

Randomization & Analysis

  • Generate or oversee randomization schedules

  • Support integrated analyses and regulatory submissions


3. Programming & Data Review

Statistical Programming Oversight

  • Create/review programming specifications

  • Support SAS programming activities when required

Database & CRF Review

Review:

  • Annotated CRFs

  • Database structures

  • Analysis datasets

  • Statistical outputs

Quality Control

  • Perform QC and validation of statistical deliverables

  • Ensure outputs align with SAPs and specifications


4. Regulatory & Compliance Support

Regulatory Interaction

Participate in:

  • Regulatory meetings

  • Sponsor discussions

  • Agency response preparation

Compliance & Standards

Ensure adherence to:

  • SOPs

  • Work Instructions (WIs)

  • ICH guidelines

  • Regulatory requirements

Inspection Readiness

  • Maintain organized project documentation

  • Support audit and inspection readiness


5. Data Monitoring & Safety Oversight

DSMB / DMC Participation

May participate in:

  • Data Safety Monitoring Boards (DSMB)

  • Data Monitoring Committees (DMC)

Possible responsibilities:

  • Charter development

  • Independent non-voting statistician role

  • Voting statistician role


6. Project & Timeline Management

Study Management

  • Monitor project timelines and milestones

  • Manage multiple studies simultaneously

Operational Coordination

  • Communicate risks and delays proactively

  • Escalate out-of-scope tasks

  • Adjust priorities based on business needs


7. Business Development Support

Sponsor Engagement

Contribute to:

  • Proposals

  • Budget planning

  • Bid defense meetings

Strategic Support

  • Support operational and process improvement initiatives


Required Skills & Competencies

Technical Expertise

  • Advanced biostatistics knowledge

  • Clinical trial design expertise

  • Statistical methodology expertise

Programming & Systems Knowledge

  • SAS programming understanding

  • Knowledge of:

    • Analysis datasets

    • TLF generation

    • Clinical databases

Leadership Skills

  • Team mentoring and development

  • Stakeholder management

  • Cross-functional collaboration

Analytical Skills

  • Strong problem-solving ability

  • Ability to manage complex analyses and submissions

  • Time management across multiple projects

Communication Skills

  • Strong written and verbal communication

  • Ability to interact with sponsors and regulatory agencies


Work Environment

  • Remote global clinical development environment

  • Highly collaborative international teams

  • Fast-paced project-driven operations


Career Growth Opportunities

Syneos Health provides:

  • Career progression opportunities

  • Leadership development

  • Technical and therapeutic training

  • Exposure to global clinical programs

  • Inclusive and collaborative culture