Biostatistician in Oro Valley, AZ at Apex Life Sciences

Date Posted: 9/26/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    9/26/2018
  • Job ID:
    890071

Job Description


Apex Life Sciences is seeking a Biostatistician to provide statistical support to development and clinical research projects. This candidate will interact with research personnel to ascertain needs and develops appropriate design and statistical solutions and write statistical analysis plans (SAPs) and statistical reports for use by internal and external customers.

Responsibilities:

  • 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.

Qualifications  

  • Masters degree in Statistics or a related field required; PhD degree in Statistics or a related field preferred
  • Masters with 3+ years statistical analysis in a healthcare environment or PhD plus significant experience in analysis and reporting using statistical software.
  • Experience with SAS strongly preferred
  • Design of Experiments (DOE) experience preferred
  • Experience in FDA submissions and in vitro diagnostic tests a plus
  • Knowledge of 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.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, 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 844-463-6178.




890071