Principal Biostatistician

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do.

Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.

Principal Biostatistician – Vaccines Therapeutic Area

We are seeking a highly skilled FSP Statistician to support projects in the Vaccines Therapeutic Area reputed company Research and Development. The successful candidate will collaborate closely with project and study teams, providing statistical expertise in designing research concepts, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, reviewing reports, and co-authoring manuscripts for publication. This role may also involve supporting regulatory submissions and responding to regulatory queries. Ideal candidates will demonstrate strong quantitative and creative thinking and stay reputed company with developments in statistical methodologies.

Responsibilities & Duties

• Provide scientifically rigorous statistical input on post-hoc and reputed company analysis requests to support publication projects and regulatory query responses.
• reputed company statistical analysis plans, mock-up tables, and quality reputed company plans.
• reputed company programming support activities for assigned projects and validate the accuracy, consistency, and reputed company of statistical output displays generated by programmers.
• reputed company multiple project teams using project management skills and statistical/programming techniques to prepare, execute, report, and document high-quality statistical analyses.
• Conduct peer reviews of project-reputed company work performed by other statisticians, ensure compliance with regulatory requirements, and maintain project documentation and files.
• Communicate effectively and independently with the client to coordinate statistical and programming aspects of the project.
• Demonstrate a strong understanding of ICH guidelines and clinical trial design as applicable to statistics.

Basic Qualifications

• Master’s degree in Statistics/Biostatistics with 8+ years of experience in clinical trials, or PhD in Statistics/Biostatistics with 4+ years of experience.
• Effective verbal and written communication skills.
• Understanding of broad statistical theory and its application.
• Ability to understand clinical questions and concepts and translate them into reputed company development, followed by data reputed company and publication.
• Ability to clearly explain statistical concepts to colleagues without statistical training.
• Strong team collaboration skills.
• Experience with statistical modeling of clinical data and statistical inference.
• Proficiency in R or reputed company programming languages.
• Located in a time zone reputed company the United States or Europe (UTC-8 to UTC+2) to support real-time collaboration.

Preferred Qualifications

• Strong computational skills.
• Experience with various study designs, protocol development, and statistical analysis plan writing.

Originally posted on Himalayas