Biostatistician

Company Description AlzaSyno Life Sciences is a Contract Research Organization (CRO) providing end-to-end services to pharmaceutical, biopharmaceutical, medical device, and Ayurvedic organizations. The company delivers expertise across clinical operations, data management, biostatistics, medical writing, and regulatory affairs, supporting studies from Phase 1 to Phase 4. Teams design and manage clinical trials, ensure regulatory compliance, and oversee accurate data collection, validation, and analysis. AlzaSyno Life Sciences also prepares documentation for regulatory submissions and acts as a liaison with global regulatory authorities, helping clients navigate complex approval pathways efficiently.

Role Description The Biostatistician role at AlzaSyno Life Sciences is a full-time, on-site position based in Gurugram. The Biostatistician will design statistical analysis plans for clinical trials across multiple phases and therapeutic areas, ensuring appropriate methodologies are selected and applied. Day-to-day responsibilities include performing statistical analyses, conducting survival and other advanced analyses, validating datasets, and interpreting results to support clinical and regulatory decisions. The role involves preparing statistical sections of clinical study reports, contributing to regulatory submission packages, and collaborating closely with clinical operations, data management, and medical writing teams. The Biostatistician will also participate in protocol development, sample size calculations, and ongoing review of study data for quality and consistency.

Qualifications

• Strong foundation in Statistics, including clinical trial methodology and study design.
• Proficiency in Statistical Programming and Statistical Software (e.g., SAS, R, or equivalent).
• Demonstrated Analytical Skills for interpreting complex clinical data and generating meaningful insights.
• Experience with Survival Analysis and other advanced biostatistical techniques.
• Master’s degree or higher in Biostatistics, Statistics, Mathematics, or a related quantitative discipline.
• Experience in biostatistics within a CRO, pharmaceutical, or clinical research environment is preferred.
• Ability to collaborate in cross-functional teams and communicate statistical concepts clearly to non-specialists.
• Attention to detail, strong documentation skills, and commitment to regulatory and data integrity standards.