Senior/Principal Biostatistician Overview • The Senior/Principal Biostatistician will provide expert statistical support for clinical trials and medical research projects. • Collaborate with clients and internal teams to ensure high-quality statistical services and timely project delivery. • Represent the biostatistics function in complex projects, offering analytical and problem-solving expertise. • Contribute to protocol development, clinical study reports, and integrated statistical documents. • Ensure compliance with regulatory guidelines and Good Clinical Practice (GCP) standards. • Leverage advanced statistical software and tools to perform data analysis and interpretation. • Work remotely, providing flexibility and autonomy in a dynamic environment. • Opportunity to collaborate with a diverse range of clients and stakeholders. Senior/Principal Biostatistician Key Responsibilities & Duties • Coordinate and manage statistical activities for clinical trial projects as the project statistician. • Develop statistical sections of protocols, reports, and integrated clinical/statistical documents. • Ensure smooth communication between clients and offshore teams to maintain project progress. • Provide oversight and guidance on statistical methodologies and data handling techniques. • Analyze and interpret clinical trial data using advanced statistical software. • Maintain compliance with regulatory standards and guidelines throughout project execution. • Collaborate with cross-functional teams to achieve project objectives and timelines. • Contribute to the development and improvement of statistical processes and practices. Senior/Principal Biostatistician Job Requirements • Master’s Degree in Statistics/Biostatistics with 3+ years of clinical trial experience, or PhD with 1+ year. • In-depth knowledge of Phase I-III drug development and Phase IV/post-marketing research. • Proficiency in SAS and related statistical software packages. • Comprehensive understanding of regulatory guidelines and GCP/ICH standards. • Strong analytical, problem-solving, and project management skills. • Exceptional interpersonal and communication skills for client and team interactions. • Ability to prioritize tasks and manage multiple projects effectively. • Experience in data analysis, interpretation, and statistical methodology application.