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