Senior Biostatistician

Job Description

Senior Biostatistician Location: Chennai, India (Hybrid/Remote options available) Department: Biostatistics About the Company A well-established, full-service CRO with over three decades of experience supporting statistical analyses and programming across all phases of drug development. The Biostatistics Division is recognized for its scientific integrity, quality deliverables, and timely execution. Role Overview The organization is seeking an experienced Senior Biostatistician to lead statistical activities in clinical trials. This individual will uphold high standards of scientific rigor and ensure regulatory compliance while working closely with teams across clinical data management, programming, and medical writing. Key Responsibilities Contribute to study design and draft statistical sections of clinical trial protocols Perform sample size and power calculations; generate randomization schedules Develop and review Statistical Analysis Plans (SAPs) and table shells Conduct statistical programming to generate efficacy-related tables, listings, and figures Review statistical output for accuracy and completeness Conduct literature reviews to support statistical methods Ensure adherence to internal guidelines and external regulatory standards Participate in client and regulatory audits Contribute to interpreting clinical trial results and assess clinical relevance Collaborate with cross-functional teams throughout the project lifecycle Qualifications Master’s or Ph.D. in Biostatistics, Statistics, or related field At least 5 years of experience in clinical trial biostatistics within a CRO or pharma environment Proficient in SAS and/or R Strong understanding of statistical methodologies including linear regression, survival analysis, and Bayesian approaches Experience analyzing and interpreting clinical data Familiarity with statistical analysis plans and research study design Excellent analytical and problem-solving abilities High attention to detail and accuracy Strong communication skills, with the ability to explain complex statistical concepts to varied audiences Capable of working independently and in a team setting Preferred Skills Experience with CDISC standards (SDTM, ADaM) Knowledge of regulatory guidelines (FDA, EMA, ICH) Strong interpersonal and project management skills Experience mentoring junior statisticians and contributing to SOPs, templates, or standards Show more Show less