Biostatistician

Job Detail

Experience Level Mid Level
Degree Type Master of Science (MS)
Employment Temporary
Working Type Remote
Salary Type Hourly
Industry Pharmaceuticals
Selling Points
Large Biopharmaceutical company offering a very strong pipeline and potential growth.

Summary:

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.

Duties:

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 can:

Review case report form (CRF) and provide comments and feedback.
Develop statistical analysis plan (SAP).
Provide 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, prepare
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.
Support/participate in project related activities including preparation of BLA submissions and oversee
CRO deliverables for studies contracted out

Requirements: