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Biostatistician II

Company: Apex Systems
Location: Tucson
Posted on: February 21, 2021

Job Description:

Biostatistician IILarge, growing Medical Device Company in Tucson needs a bright, SAS savvy Biostatistician to help out with their team. Working from home is allowed during COVID and beyond as long as you are open to working AZ business hours.Provides statistical support to development and clinical research projects; interacts with research personnel to ascertain needs and develops appropriate design and statistical solutions. Writes statistical analysis plans (SAPs) and statistical reports for use by internal and external customers.Responsibilities --- Interacts with development and clinical investigators to designs 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.Skills and Experience Masters plus 3 years' statistical analysis in a healthcare environment or PhD plus significant experience in analysis and reporting using statistical software -Experience with SAS -Design of Experiments (DOE) experience -Experience in FDA submissions and in vitro diagnostic testsKnowledge, Skill or Ability --- 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.Apply today for immediate consideration to EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or - provided by Dice

Keywords: Apex Systems, Tucson , Biostatistician II, Other , Tucson, Arizona

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