Senior Biostatistician

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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

Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
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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