Title: Biostatistician
Location: Remote
PR: $65-$75/HR
Type: Contract - Renewable
Therapeutic area: Immunology & InflammationThe 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.
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 a member of the 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 the preparation of study protocol and amendments.
- Perform relevant sample size calculations and write the statistical methodology section of the protocol.
This role might be for you if you have experience:
- Reviewing case report forms (CRF) and providing comments and feedback.
- Developing statistical analysis plans (SAP).
- Providing the 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.
- Performing statistical analysis according to the SAP, validating analysis programs, and reviewing TFLs.
- Preparing statistical methods and results sections for the clinical study report (CSR), providing statistical insight into interpretation and discussion of study results, and working with the study team to move the CSR through the review/approval process.
- Supporting/participating in project-related activities including preparation of BLA submissions and overseeing CRO deliverables for studies contracted out.
To be considered for this opportunity, you must have the following:
- Master's Degree in Statistics or Biostatistics.
- 2+ years of clinical trial experience.
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