Job Title: Senior Biostatistician
Location: Pune, Maharashtra, India
Job ID: 25105769
Company: Syneos Health
Employment Type: Full-Time
Experience Required: 4–8+ years of clinical trial biostatistics experience (or equivalent combination of education and industry exposure)
About the Company
Syneos Health is a globally recognized, fully integrated biopharmaceutical solutions organization committed to accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, the organization delivers patient-centric solutions that support regulatory approvals and market access worldwide. With operations in over 110 countries and 29,000+ professionals, Syneos Health contributes to the majority of recent global novel drug approvals.
Role Overview
The Senior Biostatistician will provide comprehensive statistical leadership and support across the full clinical trial lifecycle—from protocol development to Clinical Study Report (CSR) submission. This role requires expertise in statistical design, analysis methodologies, regulatory compliance, and programming to ensure the delivery of high-quality, inspection-ready outputs.
The position offers exposure to global clinical programs, regulatory interactions, and cross-functional collaboration within a dynamic CRO environment.
Key Responsibilities
Provide statistical support throughout all assigned clinical trial phases, from protocol development to final CSR.
Develop and review Statistical Analysis Plans (SAPs), including mock shells for tables, listings, and figures (TLFs).
Contribute to protocol statistical sections, randomization schedules, and statistical inputs to publications and clinical study reports.
Lead or support integrated analyses and complex statistical evaluations.
Create and review programming specifications for analysis datasets and outputs.
Review annotated Case Report Forms (CRFs), database structures, and study documentation to ensure alignment with protocol objectives.
Perform quality control and verification of statistical deliverables to ensure consistency with SAPs and regulatory requirements.
Coordinate biostatistics and statistical programming activities to meet project timelines and quality standards.
Participate in Data Monitoring Committees (DMCs) or Data Safety Monitoring Boards (DSMBs), including charter development and independent statistical support when required.
Support regulatory agency submissions and respond to statistical queries.
Contribute to proposal development, budgeting, and sponsor bid defense meetings.
Mentor junior biostatistics team members and promote best practices.
Maintain complete, organized, and inspection-ready documentation in compliance with SOPs, WIs, and ICH guidelines.
Provide statistical programming support using industry-standard tools (e.g., SAS or equivalent).
Required Qualifications
Master’s or PhD in Biostatistics, Statistics, Mathematics, or related quantitative discipline.
4–8+ years of experience in clinical trials biostatistics within CRO, pharmaceutical, or biotechnology environments.
Strong knowledge of clinical trial design, statistical methodologies, and regulatory guidelines (ICH, FDA, EMA).
Proficiency in statistical programming (SAS preferred).
Experience preparing SAPs and leading statistical deliverables for Phase I–IV studies.
Strong written and verbal communication skills with the ability to present statistical concepts to cross-functional stakeholders.
Ability to manage multiple projects, prioritize tasks, and meet strict timelines.
Preferred Competencies
Experience in integrated analyses and regulatory submissions.
Exposure to adaptive trial designs and advanced statistical modeling.
Experience interacting with global sponsors and regulatory authorities.
Leadership or mentoring experience within biostatistics teams.
Why Join Syneos Health
Opportunity to work on global clinical development programs.
Exposure to regulatory submissions and multinational trials.
Strong focus on professional growth, leadership development, and technical excellence.
Collaborative and inclusive workplace culture.
Additional Information
Responsibilities may evolve based on business requirements. Equivalent education and relevant experience may be considered. The organization is committed to regulatory compliance, equal opportunity employment, diversity, and inclusion.
SEO Keywords: Senior Biostatistician Jobs Pune, Clinical Trials Biostatistics Careers India, CRO Biostatistician Role, SAP Development Clinical Research, SAS Programming Jobs India, Clinical Data Analysis Careers, Global Clinical Research Jobs, Regulatory Biostatistics Roles.
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