Senior/Principal Biostatistician

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.