Description
The Biostatistics and Data Management group is looking for a Biostatistician to support Early Clinical Development and Exploratory Data Analysis. This position is for a qualified statistician with experience in the pharmaceutical/biotechnology sector, to collaborate in cross-functional drug development teams to execute innovative development strategies for compounds entering early clinical development and to perform exploratory data analysis.
The incumbent will work under the direct supervision of permanent statisticians, to work with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate the requisite data and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. The incumbent will work with more experienced project statisticians to co-author statistical analysis plans and perform statistical analyses for interim and final reports.
Responsibilities
- Under direct supervision and guidance of senior departmental staff, to perform exploratory data analyses to answer drug development questions, in collaboration with clinicians and other scientists.
- Under direct supervision and guidance of senior departmental staff, to provide support to a clinical study team on all relevant statistical matters and to perform statistical analysis of data from the trial.
- 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.
- 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.
