Job Title

Senior Biostatistician Location: Chennai, India (Hybrid/Remote options available) Department: BiostatisticsAbout 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 ResponsibilitiesContribute to study design and draft statistical sections of clinical trial protocolsPerform sample size and power calculations; generate randomization schedulesDevelop and review Statistical Analysis Plans (SAPs) and table shellsConduct statistical programming to generate efficacy-related tables, listings, and figuresReview statistical output for accuracy and completenessConduct literature reviews to support statistical methodsEnsure adherence to internal guidelines and external regulatory standardsParticipate in client and regulatory auditsContribute to interpreting clinical trial results and assess clinical relevanceCollaborate with cross-functional teams throughout the project lifecycleQualificationsMaster’s or Ph.D. in Biostatistics, Statistics, or related fieldAt least 5 years of experience in clinical trial biostatistics within a CRO or pharma environmentProficient in SAS and/or RStrong understanding of statistical methodologies including linear regression, survival analysis, and Bayesian approachesExperience analyzing and interpreting clinical dataFamiliarity with statistical analysis plans and research study designExcellent analytical and problem-solving abilitiesHigh attention to detail and accuracyStrong communication skills, with the ability to explain complex statistical concepts to varied audiencesCapable of working independently and in a team settingPreferred SkillsExperience with CDISC standards (SDTM, ADaM)Knowledge of regulatory guidelines (FDA, EMA, ICH)Strong interpersonal and project management skillsExperience mentoring junior statisticians and contributing to SOPs, templates, or standards