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The Principal Biostatistician generates derived datasets, tables, listings, and figures (TLFs) of clinical trial data, performs quality control of TLFs and derived data sets created by other Biostatisticians, and may be asked to assist in the preparation of statistical plans. The Principal Biostatistician successfully supports Biostatistics leads and senior reviewers in the execution of deliverables by managing the timelines and budget of assigned tasks. This individual supports Business Development by assisting with Biostatistics costs for proposals, and attending bid defense and capabilities meetings when required.
Additionally, the Principal Biostatistician prepares specifications for analysis data sets and independently drafts statistical analysis plans. This individual also acts as Lead Biostatistician on assigned projects, interacts with the study team and the Sponsor, and is responsible for tracking project revenue, backlog, and hours worked on projects, and will forecast the necessary hours to complete a project. In addition, he/she also supervises SAS programming and program validation for projects.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
You’ll Need this to be Considered:
- Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field with 6- 8 years of experience in clinical trials design and analysis using SAS
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
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