Senior / Principal Biostatistician – Immunology & Inflammation (Europe & LATAM Only)
Updated: Yesterday
Location: Pune, Maharashtra, India (Global Role – Europe & LATAM Eligibility Only)
Job ID: 25105208-OTHLOC-5580-2DR
Job Overview
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, recognized globally for accelerating clinical development and regulatory success. By integrating clinical, medical affairs, and commercial expertise, Syneos Health delivers impactful solutions that advance innovative therapies across global markets.
We are seeking an experienced Senior or Principal Biostatistician specializing in Immunology and Inflammation, with strong leadership capabilities across late-phase clinical trials (Phase II–III). This role is open exclusively to candidates based in Europe and Latin America, with eligibility to work without company sponsorship.
Eligibility & Work Authorization
Open to Europe and LATAM candidates only
Must be legally authorized to work in the eligible region without visa sponsorship
Minimal travel may be required
Experience Required
Senior Biostatistician: 6–8+ years of clinical biostatistics experience
Principal Biostatistician: 9–12+ years of progressive biostatistics leadership experience
Proven experience leading late-phase (Phase II–III) clinical studies
Strong background in Immunology and Inflammation therapeutic areas
Hands-on expertise with SAS and/or R programming environments
Key Responsibilities
Study Leadership & Statistical Oversight
Act as study lead biostatistician for 1–2 clinical protocols, primarily Phase II–III
For large Phase III trials, provide statistical leadership while supporting a lead statistician
Develop and oversee Study Risk Management Plans (SRMPs)
Lead or support DMC/DSMB setup, charter development, and ongoing statistical surveillance
Statistical Deliverables
Prepare and review Statistical Analysis Plans (SAPs)
Develop and validate Tables, Listings, and Figures (TLFs) and Statistical Tables Shells (STS)
Perform statistical surveillance (STS) including blinded data reviews and interim assessments
Assess data quality, protocol compliance, statistical assumptions, and intercurrent events
Support IRT, eCRF design, database specifications, and annotated CRFs
Programming & Technical Review
Create and review programming specifications for analysis datasets and outputs
Provide hands-on or partial efficacy programming as required
Conduct quality control and verification of statistical outputs to ensure alignment with SAPs
Review blinded and unblinded data to support patient recruitment assessment and trial integrity
Cross-Functional Collaboration
Serve as the biostatistics representative on cross-functional project teams
Coordinate and review work of other biostatisticians and statistical programmers
Participate in regulatory agency interactions and respond to statistical queries when required
Monitor study timelines, identify risks or scope changes, and proactively escalate issues
Leadership & Business Support
Mentor and coach junior biostatistics staff
Contribute to business development activities, including proposals, budgets, and bid defenses
Support integrated analyses and submission-level statistical activities
Maintain inspection-ready documentation in compliance with ICH, SOPs, and regulatory guidelines
Qualifications
Education
Master’s or PhD in Biostatistics, Statistics, Mathematics, or a related scientific discipline
Technical & Professional Skills
Advanced expertise in SAS and/or R
Strong knowledge of clinical trial design, analysis methodologies, and regulatory expectations
Excellent written and verbal communication skills in English
Demonstrated ability to manage multiple global projects with competing priorities
Strong analytical thinking, leadership, and stakeholder management skills
Why Join Syneos Health
Opportunity to work on trials supporting 95% of EMA-authorized products
Exposure to global, high-impact clinical development programs
Collaborative, inclusive culture focused on career growth and scientific excellence
Work with industry-leading experts across biostatistics, clinical development, and regulatory affairs
About Syneos Health
Over the past five years, Syneos Health has supported:
94% of all novel FDA-approved drugs
95% of EMA-authorized products
200+ studies across 73,000 sites and more than 675,000 clinical trial patients
With operations in over 110 countries and a workforce of 29,000+ professionals, Syneos Health continues to redefine how biopharmaceutical development is delivered globally.
Disclaimer
The duties and responsibilities outlined above are not exhaustive and may be amended based on business needs. Syneos Health reserves the right to determine equivalent qualifications and experience. This posting does not constitute an employment contract. The company is committed to equal employment opportunity and compliance with applicable global employment laws and accessibility requirements.
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