BIOSTATISTICIAN

As a Biostatistician, you will be responsible for the implementation and execution of statistical aspects of clinical development projects.

Specific responsibilities include:

• Provide support to the programmers and medical writers on all statistical matters according to client requirements
• Provide input into statistical sections of the protocol, amendments, Clinical Development Plan and protocol development working with the client’s statistical group
• Develop statistical analysis plan (SAP) and assist in preparing the data validation plan based on guidance from client
• Work with programming team to provide definitions, documentation, and review of derived variables needed to produce planned tables, listings, and graphs (TLGs)
• Develop data and programming specifications jointly with programmers
• Assist in designing data presentations including summary tables, graphs, and subject listings
• Monitor data quality from a study conduct and output perspective
• Perform statistical analysis according to the SAP, validate analysis programs, review TLGs, prepare statistical methods and results sections for the clinical study report (CSR)
• Perform and/or coordinate and oversee the preparation, execution, reporting and documentation of all analyses (interim and final)
• Assist in writing efficacy sections of clinical study reports and summary documents with in-house medical writers and the client’s study team
• Assume responsibility for quality and statistical integrity of clinical study reports and summary documents
• Perform analyses and prepare data presentations for clinical registration dossiers based on strategies developed by the client
• Mentor and provide guidance to medical writers and other team members as appropriate