Senior Biostatistician (Office Based in Tucson, Arizona)
Posted on: March 11, 2020
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
- Writes statistical analysis plans as needed to capture design
elements and statistical methodology.
- Performs data analysis and prepares statistical reports of
- 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
- Evaluates databases and statistical analysis programs and
Interacts with data management and IT groups to determine
- 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
- 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
- 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
- Experience with SAS, R and/or any other statistical tool.
- Experience in FDA submissions and in vitro diagnostic
- Preferred: Design of Experiments (DOE) experience.Join UsMaking
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/DisabledIQVIA, 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 IQVIAs Talent Acquisition team
at email@example.com_ to arrange for such an
accommodation.At IQVIA, we have a vision. Where every healthcare
decision is based on evidence. Where data science and human science
come together to improve global health. Where new and creative
solutions arent just possible they are expected.Thank you for your
interest in growing your career with us. It takes insight,
curiosity, and intellectual courage to transform healthcare. The
56,000+ employees of the IQVIA family of companies, including Q2
Solutions, are reimagining a world without the consequences of
disease. We are brave minds bringing powerful ideas to reality. At
IQVIA, you can truly make an impact in an environment where youre
supported to succeed.
Keywords: IQVIA, Flagstaff , Senior Biostatistician (Office Based in Tucson, Arizona), Administration, Clerical , Flagstaff, Arizona
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