Senior Biostatistician (Office Based in Tucson, Arizona) (R1121039) in Bloomington, IL at IQVIA™

Date Posted: 4/2/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    4/2/2020
  • Job ID:
    R1121039

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Purpose:

Provides statistical support to development and clinical research projects.  Interacts with research personnel 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 by other groups, and plays an active role in organizational surveillance to ensure statistical quality. Has primary ownership of at least one major project and actively mentors less experienced colleagues as needed. Functional support activities include providing training materials, presenting at internal and external professional conferences, identifying and solving technical challenges, developing and implementing novel statistical methodologies. Monitors work to ensure quality, and continuously promote Quality First Time.

Essential Functions:

  • 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 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.
  • Troubleshoots and improves current statistical designs, including those developed elsewhere in the organization
  • Develops novel statistical innovations as needed.
  • Continuously monitors the organizational environment for opportunities to improve research design throughout the company.
  • Evaluates databases and statistical analysis programs and Interacts with data management and IT groups to determine hardware/software compatibility.
  • Maintains expertise in state-of-the-art data manipulation and statistical analyses, and actively mentors colleagues.
  • Manages day-to-day operational aspects of multiple projects.

Required Knowledge, Skills and Abilities:

  • 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.
  • Ability to prioritize and plan work activities.
  • Skill in managing multiple projects.
  • Maintains broad knowledge of state-of-the-art statistical methods.
  • Participates in the development and implementation of novel statistical methods to increase efficiencies and likelihood of successful product commercialization.
  • Demonstrated expert matter expertise in the form of publications, white papers, or technical presentations.

Minimum Required Education and Experience:

  • Masters degree in Statistics or a related field.
  • Significant experience in analysis and reporting using statistical software.
  • Experience with SAS, R and/or any other statistical tool.
  • Experience in FDA submissions and in vitro diagnostic tests.
  • Preferred: Design of Experiments (DOE) experience.  

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1121039

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