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BIOSTATISTICIAN SENIOR

Company: Apex Systems
Location: Pleasanton
Posted on: August 2, 2020

Job Description:

Provide statistical support for clinical trials and other functions such as research development, quality, and marketing as needed. Interacts and consults with clinical and project teams to ascertain their needs and develop appropriate design and statistical solutions. Writes statistical analysis plans and reports for use by internal and external customers. Critiques and improves study designs developed across the organization. Has primary ownership of at least one major project and actively mentors less experienced colleagues as needed. Responsibilities Interacts with development and clinical investigators to design clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims. Writes statistical analysis plans as needed to capture design elements and statistical methodology. Performs statistical analyses and prepares statistical reports of results. Reviews statistical analyses conducted by statistical programmers and other biostatisticians to ensure accuracy and quality. Conducts randomization and blinding of samples. Troubleshoots and improves current statistical designs, including those developed elsewhere in the organization. Maintains expertise in state-of-the-art data manipulation and statistical analyses, and mentors less experienced colleagues. Manages day-to-day operational aspects of a project. Monitors work to ensure quality. Skills 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. Ability to prioritize and plan work activities. Education Master's Degree in Statistics or a related field is required. Ph.D. in Statistics or a related field is prefered. Experience 6 years minimum with Masters degree of relevant experience 3 years minimum with PhD degree of relevant experience Experience with SAS EEO Employer Apex 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 employeeservicesapexsystemsinc.com or 844-463-6178.SDL2017

Keywords: Apex Systems, Pleasanton , BIOSTATISTICIAN SENIOR, Other , Pleasanton, California

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