Temp - Biostatistician - Immunology & Inflammation from Joulé

The Biostatistician implements and executes methodological and statistical aspects of clinical studies under the supervision of Therapeutic Area lead biostatistician or project lead statistician. In some cases, principal function could be to develop/employ technical expertise in a particular statistical area or application.

In this role, a typical day might include:

• Under direct supervision and guidance of senior departmental staff, provide support to a clinical study

• team on all relevant statistical matters. As member of study team, ensure the clinical study is conducted

• in a manner that supports planned statistical analysis.

• Under supervision and guidance of senior departmental staff, participate in preparation of study protocol and amendments

• Perform relevant sample size calculations and write statistical methodology section of the protocol

This role might be for you if have experience:

• Reviewing case report form (CRF) and provide comments and feedback.

• Developing statistical analysis plan (SAP).

• Providing programming team with definitions and documentation for derived variables needed to produce planned Tables, Figures and Listings (TFLs). Develop data and programming specifications jointly with programmers.

• Perform statistical analysis according to the SAP, validate analysis programs, review TFLs

• Preparing statistical methods and results sections for the clinical study report (CSR), provide statistical insight into interpretation and discussion of study results, and work with the study team to move the CSR through review /approval process.

• Supporting/participating in project related activities including preparation of BLA submissions and oversee CRO deliverables for studies contracted out

To be considered for this opportunity, you must have the following: 

• Master Degree in Statistics or Biostatistics 

• 2+ years of clinical trial experience