Senior Biostatistician

Senior Biostatistician Overview

• The Senior Biostatistician will provide statistical support and oversight for complex clinical research projects.
• Represent the biometrics function to ensure high-quality deliverables and client satisfaction.
• Collaborate with internal and external teams to manage project timelines and communication.
• Contribute to protocol development, clinical study reports, and integrated statistical reports.
• Utilize advanced statistical methods to analyze and interpret clinical trial data.
• Ensure compliance with GCP, ICH guidelines, and regulatory requirements.
• Leverage expertise in SAS and related software for data analysis and reporting.
• Provide mentorship and guidance to junior statisticians and project teams.

Senior Biostatistician Key Responsibilities & Duties

• Coordinate and manage statistical activities for assigned clinical research projects.
• Develop statistical methodologies for protocols, reports, and integrated analyses.
• Liaise with clients to ensure smooth communication and project progress.
• Perform data analysis and interpretation using SAS and other statistical tools.
• Ensure adherence to regulatory guidelines and industry standards.
• Collaborate with offshore teams to deliver timely and accurate results.
• Provide technical expertise in Phase I-IV drug development and post-marketing research.
• Contribute to the continuous improvement of statistical processes and methodologies.

Senior Biostatistician Job Requirements

• Master’s Degree in Statistics/Biostatistics with 3+ years of clinical trial experience, or PhD with 1+ year.
• Extensive knowledge of theoretical and applied statistics in medical research.
• Proficiency in SAS and related software packages for data analysis.
• In-depth understanding of Phase I-III drug development and Phase IV/post-marketing research.
• Familiarity with GCP and ICH guidelines for pharmaceutical registration.
• Strong analytical, problem-solving, and project management skills.
• Excellent interpersonal and communication skills for client and team interactions.
• Competency in Microsoft Office tools including Word, PowerPoint, and Excel.