Top MNC Hiring - Expert Biostatistician

Job Description

Select the apt sample size; collect data; perform the test; and develop TLG (tables, listings, and graphs); and finally, report the inference. Review of ADaM Specifications and TLGs. Develop statistical analysis plans (SAPs) in alignment with clinical protocols and regulatory guidelines (ICH, FDA, EMA). Perform and validate complex statistical analyses using SAS and R , ensuring accuracy and reproducibility. Provide statistical input into clinical study design, sample size calculation, randomization, and data collection strategies. Collaborate closely with Clinical, Data Management, Medical Writing, and Regulatory Affairs teams. Present and interpret statistical findings to non-technical stakeholders and contribute to publications or regulatory submissions (CSR, ISS/ISE, etc.). Lead or contribute to the development of standard operating procedures (SOPs), templates, and best practices. Mentor junior statisticians and provide peer review of statistical deliverables. Excellent written and verbal communication skills. Ability to manage multiple projects and priorities in a fast-paced environment. Location : Pan India Shift : General Shift