Principal Biostatistician – Pune, Maharashtra
Job Summary:
Syneos Health is seeking a Principal Biostatistician in Pune, India, to lead and manage statistical strategies for global clinical trials. This role is pivotal in delivering statistical support from study design through regulatory submissions. Ideal for experienced biostatistics professionals with strong expertise in SAS, CDISC, and regulatory standards, this position offers the opportunity to work in a dynamic, global, and collaborative pharmaceutical environment.
Key Responsibilities:
Lead statistical design and analysis planning for clinical studies across multiple phases
Serve as primary statistical contact for internal teams and external sponsors
Develop and review statistical analysis plans (SAPs), ADaM specifications, and TLF shells
Perform statistical analyses using SAS and validate results for regulatory compliance
Ensure deliverables align with CDISC standards and global regulatory guidelines
Participate in regulatory submissions, including responses to health authority queries
Provide mentorship to junior biostatisticians and review their deliverables for quality
Support study setup, interim reviews, database locks, and final analysis processes
Contribute to the development of biostatistical methodologies and SOPs
Work cross-functionally with data management, programming, and medical writing teams
Required Skills & Qualifications:
Ph.D. or Master’s degree in Biostatistics, Statistics, or related field
Minimum 7+ years of experience in clinical biostatistics in the pharmaceutical/CRO industry
Advanced knowledge of SAS programming, especially in statistical procedures
Proficient in CDISC standards including SDTM and ADaM
Familiarity with regulatory guidelines (ICH E9, E3, GCP, FDA/EMA standards)
Strong analytical, communication, and leadership skills
Experience supporting global clinical trials and regulatory submissions
Perks & Benefits:
Competitive salary and incentive-based rewards
Access to global career development and therapeutic training
Work with a diverse team across 110+ countries
Be part of a company contributing to 94% of all FDA-approved drugs
A culture of inclusivity and recognition under the Total Self philosophy
Opportunity to lead high-impact projects in a clinical research-focused environment
Company Description:
Syneos Health is a global leader in integrated biopharmaceutical solutions. The company partners with pharmaceutical and biotech organizations to deliver successful clinical trials and commercialization outcomes. With over 29,000 employees in 110 countries, Syneos supports clinical research across multiple therapeutic areas, making a meaningful difference in healthcare.
Work Mode:
On-site – Pune, Maharashtra, India
Call to Action:
Ready to take your biostatistics career to the next level? Join Syneos Health as a Principal Biostatistician and drive innovation in clinical research.
Gujarat :
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