Unlock Your Potential as a Principal Biostatistician – India Join a dynamic and forward-thinking team at a leading global organization, where your expertise can drive groundbreaking clinical research. We are looking for a highly experienced Principal Biostatistician to lead statistical analyses, shape study strategies, and collaborate with top-tier stakeholders. This is a strategic, high-impact role perfect for professionals ready to elevate their career while working remotely in India. What You’ll Bring: • Over 10 years of industry experience in biostatistics, including study leadership roles • Extensive hands-on expertise in safety and efficacy data analysis using SAS and R, including ADAMS and datasets • Proficiency in statistical methods such as ANCOVA, MMRM, Chi-square, Fisher exact tests, confidence intervals, logistic regression, Kaplan-Meier, and log-rank analyses • Proven experience in authoring Statistical Analysis Plans (SAP), methodology development, analysis, and data specification documentation • Knowledge of clinical trial phases 1-4, randomization, sample size calculations, and re-estimation • Strong documentation review skills for CRF, SDTM, and ADAM specifications • Excellent cross-functional communication skills and client engagement experience Desirable Skills: • Advanced statistical methods including Bayesian analysis, missing data techniques (Multiple Imputation), Negative Binomial regression, estimands, and sensitivity analyses • Experience with complex efficacy analyses and study leadership in challenging projects • SAS/R coding (QC or production level) • Expertise in scientific publication review and preparation Preferred Education & Experience: • Advanced degree in biostatistics, statistics, or a related field • Prior leadership in clinical trial statistics for phases 1-4 • Demonstrated stakeholder management and negotiation skills Additional Requirements: • Remote working flexibility with an office or home setup in India • Ability to participate in multi-regional collaborations and client meetings • Understanding of global regulatory standards and documentation protocols If you are a strategic thinker with a passion for delivering innovative solutions in clinical research, we want to hear from you. Take the next step in your career and apply now to become a key driver of scientific excellence at this leading organization!