BIOSTATISTICIAN

JOB DESCRIPTION:

The statistician will collaborate with clinical investigators to determine study design, contribute to protocol development, write statistical analysis plans, perform statistical analysis, inference, writes and presents reports summarizing findings including publications in peer-reviewed journals.

Responsibilities:

• Collaborates with clinical investigators to determine study design.

• Develop systems for monitoring the quality of clinical data.

• Ensure high-quality statistical support is provided for clinical trials, registries and basic research through the use of advanced statistical skills and knowledge of clinical research. 
• Writes sections of protocols that require statistical input.
• Reviews protocols and case report forms to ensure that protocol objectives are met and standards are maintained.
• Generates treatment allocations in randomized clinical research studies and ensures proper implementation. 
• Maintain expertise in state-of-the-art data manipulation and statistical methodology
• Leads the project team’s development of statistical analysis plans and programs to perform analyses and display study data.
• Performs statistical analyses, writes and validates application programs
• Implements data and safety monitoring reports to ensure participants safety.
• Develops metrics and generates quality control reports to optimize the performance of clinical sites and the coordinating center.
• Generates study reports to be distributed to internal and external monitoring committees and regulatory bodies
• Authors or contributes to manuscripts and/or scientific presentations.
• Participates in professional development activities both within and outside the company.

Requirements:

• MS or PhD in statistics, biostatistics, epidemiology or relevant area. 
• Demonstrated proficiency with statistical methods and applications in clinical research. 
• Competent in SAS programming language and/or R. 
• Expertise in state-of-the-art data manipulation and statistical methodology
• Ability to manage multiple tasks
• Ability to work independently, as well as in a team environment
• Ability to effectively communicate technical concepts, both written and oral.