The Biostatistician implements and executes methodological and statistical aspects of clinical studies under the supervision of the Therapeutic Area lead biostatistician or project lead statistician. In some cases, the principal function could be to develop/employ technical expertise in a particular statistical area or application.
Under direct supervision and guidance of senior departmental staff, provide support to a clinical study team on all relevant statistical matters. As a member of the study team, ensure the clinical study is conducted in a manner that supports planned statistical analysis.
Under the supervision and guidance of senior departmental staff, participate in the preparation of study protocol and amendments. Perform relevant sample size calculations and write statistical methodology section of the protocol.
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 from 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
Experience and Required Skills:
A PhD and at least 2 years of biopharmaceutical experience is required.
Level will be commensurate with experience.
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