Statistician
Company: Integrated Resources Inc.
Location: Minneapolis
Posted on: January 27, 2023
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Job Description:
Integrated Resources, Inc is a premier staffing firm recognized
as one of the tri-states most well-respected professional specialty
firms. IRI has built its reputation on excellent service and
integrity since its inception in 1996. Our mission centers on
delivering only the best quality talent, the first time and every
time. We provide quality resources in four specialty areas:
Information Technology (IT), Clinical Research, Rehabilitation
Therapy and Nursing.
Job DescriptionTitle: Statistician II
Duration: 03 Months
Location: Minneapolis, MN 55432
This project will mainly consist of setting up programming code
based on the pre-existing SAP drafts and the draft report/table
shell, but may require independent thinking on aspects of the
analysis. The project will also likely include validation of code
from the internal statistician.
Position description:
The Senior Statistician will be responsible for statistical aspects
of study design and analysis of data from clinical studies
conducted for regulatory approval or marketing purposes. This
includes responsibility for design of studies, calculating of
sample size and power, writing of statistical portions of protocol
and statistical analysis plan, review of protocol and case report
forms, analysis and interpretation of data, and preparation of
relevant sections of regulatory submissions, reports, and
manuscripts. Work will generally be done independently, but will be
reviewed by the Manager at key time points.
Position responsibilities:
--- Applies statistical knowledge and experience to the design of
clinical studies, ensuring that study objectives can be met. This
requires calculation of sample size and power, as well as possible
determination of appropriate design assumptions from published
literature.
--- Prepares relevant sections of protocols, especially those
detailing the plans for data analysis, and justification for the
sample size. Reviews entire protocol for consistency.
--- Assists in development and review of case report forms,
ensuring data will be collected efficiently and accurately.
--- Identifies potential threats to study credibility and validity,
and works with study team to prevent, track, and manage potential
problems.
--- Writes the statistical analysis plan for the study, if
required. Also writes error-checking requirements for the study
data.
--- Takes responsibility for responding to relevant questions from
FDA.
--- Uses a variety of statistical methods and software tools to
analyze and display data from clinical and other studies, including
more advanced methods. Methods must be appropriate for the kind of
data collected, and required assumptions must be tested.
--- Interprets statistical and clinical findings, and ensures that
regulatory submissions, reports, and manuscripts accurately reflect
the data collected.
--- Validates and provides clear documentation of analysis
programs.
--- Writes Results and Methods sections of reports and manuscripts
as needed.
--- Consults with other (e.g. non-clinical) staff on statistical
and analysis issues.
--- Attends and contributes to project and department meetings.
QualificationsBasic qualifications:
Bachelor's degree in Biostatistics or Statistics and 5+ years of
experience in analysis of data from clinical studies and design of
clinical trials OR Master's degree in Biostatistics or Statistics
and 3+ years of experience in analysis of data from clinical
studies and design of clinical trials.
Desired/preferred qualifications (optional):
--- Specific coursework in Clinical Trials or Epidemiology.
--- Experience in study design in the medical device or
pharmaceutical industries
--- Knowledge of relational database function, and SAS Proc
SQL.
--- Strong applied statistical skills, including survival analysis
and regression modeling
--- Advanced programming skills in SAS, or another statistical
analysis package
--- Knowledgeable regarding research data management
--- High level of competency in Windows environment and with
Microsoft Office Tools (Word, Excel)
--- Demonstration of good oral and written communication
skills.
--- Well-developed interpersonal skills
Additional Information Kind Regards, Clinical Recruiter Integrated
Resources, Inc. Gold Seal JCAHO Certified --- for Health Care
Staffing
"INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th
Year in a Row)
Keywords: Integrated Resources Inc., Minneapolis , Statistician, Other , Minneapolis, Minnesota
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