Major Pharma company is looking for a Biostatistician II in Tucson, AZ. It is a 12-36 months contract on W2.
Interacts with product developers and clinical investigators to design clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims.
Writes data analysis plans as needed to capture design elements and statistical methodology.
Performs data analysis and prepares statistical reports of results.
Performs Quality Control (QC) for statistical analyses by other biostatisticians to ensure analysis quality.
Conducts randomization and blinding of samples.
Develops data entry spreadsheets as needed.
Evaluates databases and statistical analysis programs and interacts with computer groups to determine hardware/software compatibility.
Maintains expertise in state-of-the-art data manipulation and statistical analyses.
Manages technical aspects of project(s), as assigned.
Monitors work to ensure quality, and continuously promotes Quality First Time.
Minimum: Masters plus 3 years statistical analysis in a healthcare environment or PhD plus significant experience in analysis and reporting using statistical software.
Preferred: Experience with SAS // Design of Experiments (DOE) experience // Experience in FDA submissions and in vitro diagnostic tests
Knowledge of FDA guidelines for in vitro diagnostic devices and the required statistical basis for sensitivity, specificity, agreement rates, and reproducibility testing required for validation and FDA clearance and approval.
Strong ability to collaborate across departments and interact with various levels in the organization.
High attention to detail with skill in producing organized reports.
Ability to write statistical code and documentation.
Ability to work in a team-focused environment is essential, as all statistical analyses under design control require both lead statistical analysis and quality control (QC), each conducted by different individuals who must coordinate activities.
Education: Masters degree in Statistics or a related field // Preferred: PhD degree in Statistics or a related field