Biostatistician

Perform biometrics and SAS programming activities for all clinical trials involving drugs, biologics and devices, and oversees the activities of programming and biostatistician consultants.
 
• Develops statistical section in clinical trial protocol
• Samples size and statistical power calculations
• Generates randomization schedule according to the protocol
• Develops Statistical Analysis Plan with input from project team and sponsor per SOPs and WPDs
• Consults on other statistical tasks, such as support for CRFs development and study report writing
• Performs SAS programming to generate tables, listings, figures, and statistical analyses
• Develops SAS programs to build standard tabulation datasets and analysis datasets according to certain industry standard or the format requested by client
• Oversees validation and quality assurance aspects of control over SAS program content, documentation and archiving of programs
• Ensures adherence to timelines for the biostatistical and SAS programming aspects of projects
• Performs other duties assigned by supervisor

Requirements:
 
• Bachelor’s degree in Medical Statistics or related subjects, advanced degree (M.S. or
Ph.D.) preferred
• Minimum one year of experience in use of statistics as applied to drug or medical device development.
• Knowledgeable in all aspects of the Federal (FDA) regulations and requirements governing the conduct of drug and device studies including, but not limited to, GCP and ICH requirements
• Demonstrated skills in team-building and the ability to work successfully in a team environment.