Principal Biostatistician – Clinical Trials | Pune
Job Summary:
Syneos Health is seeking a Principal Biostatistician in Pune to lead and manage biostatistics activities across global clinical trials. This senior-level position is integral to clinical development programs, ensuring robust statistical methodologies and regulatory compliance. Ideal for professionals with advanced expertise in clinical trial statistics, statistical programming, and regulatory submissions, this role offers an opportunity to shape the future of healthcare innovations at a leading biopharmaceutical solutions organization.
Key Responsibilities:
Lead statistical strategy for assigned clinical studies and programs
Design statistical analysis plans (SAPs) and support protocol development
Perform complex statistical analyses for clinical trial data
Ensure compliance with ICH-GCP and regulatory standards (FDA, EMA)
Provide statistical input for regulatory submissions and meetings
Collaborate with cross-functional teams including clinical operations, data management, and medical writing
Oversee statistical programming deliverables and validation activities
Mentor junior statisticians and contribute to internal process improvements
Review and approve statistical deliverables including TFLs and CSR inputs
Required Skills & Qualifications:
Master’s or Ph.D. in Biostatistics, Statistics, or related quantitative field
Minimum 6–8 years of experience in biostatistics for clinical trials (CRO or pharma)
Strong knowledge of statistical methods for clinical data analysis
Proficient in SAS and other statistical tools/software
Familiarity with CDISC standards (SDTM/ADaM)
In-depth understanding of ICH-GCP guidelines and regulatory requirements (FDA, EMA)
Excellent written and verbal communication skills
Leadership qualities with ability to work in matrixed teams
Experience contributing to global submissions and regulatory interactions is preferred
Perks & Benefits:
Competitive compensation and performance bonuses
Global exposure with clinical programs across 110+ countries
Opportunities for career growth and internal development
Supportive work culture focused on diversity, equity, and belonging
Training programs and access to leading statistical tools and systems
Employee recognition and wellness initiatives
Company Description:
Syneos Health is a global leader in biopharmaceutical solutions, partnering with top pharma and biotech companies to accelerate the delivery of therapies. With operations across 110 countries and experience supporting 94% of novel FDA drug approvals, Syneos Health brings statistical excellence to every phase of clinical development.
Work Mode:
On-site – Pune, India
Call to Action:
Ready to lead cutting-edge statistical solutions in global trials? Apply now for the Principal Biostatistician role at Syneos Health and help shape the future of drug development.
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