Temp - Biostatistician (General Medicine)
Biostatistician (General Medicine)-R46144
Position Description
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.
Role Responsibilities
ā¢ Under direct supervision and guidance of senior departmental staff, provide support to a clinical study
ā¢ team on all relevant statistical matters. As member of study team, ensure the clinical study is conducted
ā¢ in a manner that supports planned statistical analysis.
ā¢ Under supervision and guidance of senior departmental staff, participate in preparation of study protocol
ā¢ and amendments. Perform relevant sample size calculations and write statistical methodology section of
ā¢ the protocol.
Skills
ā¢ Review case report form (CRF) and provide comments and feedback.
ā¢ Develop statistical analysis plan (SAP).
ā¢ Provide programming team with definitions and documentation for derived variables needed to produce
ā¢ planned Tables, Figures and Listings (TFLs). Develop data and programming specifications jointly with
ā¢ programmers.
ā¢ Perform statistical analysis according to the SAP, validate analysis programs, review TFLs, prepare
ā¢ statistical methods and results sections for the clinical study report (CSR), provide statistical insight into
ā¢ interpretation and discussion of study results, and work with the study team to move the CSR through
ā¢ review /approval process.
ā¢ Support/participate in project related activities including preparation of BLA submissions and oversee
ā¢ CRO deliverables for studies contracted out
Education & Experience
ā¢ Master Degree in related field required
ā¢ 2 years of relevant experience
Position Description
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.
Role Responsibilities
ā¢ Under direct supervision and guidance of senior departmental staff, provide support to a clinical study
ā¢ team on all relevant statistical matters. As member of study team, ensure the clinical study is conducted
ā¢ in a manner that supports planned statistical analysis.
ā¢ Under supervision and guidance of senior departmental staff, participate in preparation of study protocol
ā¢ and amendments. Perform relevant sample size calculations and write statistical methodology section of
ā¢ the protocol.
Skills
ā¢ Review case report form (CRF) and provide comments and feedback.
ā¢ Develop statistical analysis plan (SAP).
ā¢ Provide programming team with definitions and documentation for derived variables needed to produce
ā¢ planned Tables, Figures and Listings (TFLs). Develop data and programming specifications jointly with
ā¢ programmers.
ā¢ Perform statistical analysis according to the SAP, validate analysis programs, review TFLs, prepare
ā¢ statistical methods and results sections for the clinical study report (CSR), provide statistical insight into
ā¢ interpretation and discussion of study results, and work with the study team to move the CSR through
ā¢ review /approval process.
ā¢ Support/participate in project related activities including preparation of BLA submissions and oversee
ā¢ CRO deliverables for studies contracted out
Education & Experience
ā¢ Master Degree in related field required
ā¢ 2 years of relevant experience