45927-4677 - Statistician
Location: Saint Paul
Posted on: September 27, 2024
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Job Description:
Requisition # : 45927-4677
Start Date : 1/12/2015
End Date : 11/30/2015
Over Time Allowed : No
Interview Type : Interview
Travel : No Travel Required
Environment : Professional
Schedule : Typical 8 Hour/Day
Dress Code : Business Casual
Work Location : Mounds View, MN 55112
Labor Category : Clinical, Scientific and Laboratory Research
Job Family : Statistics
Job Title : Statistician
Job Duties :
-The statistician is responsible for data analyses and statistical
aspects of studies conducted for regulatory approval or marketing
purposes.
-This includes responsibility for writing statistical analysis
plans, analysis and interpretation of data, and preparation of
relevant sections of regulatory submissions, reports, and
manuscripts.
-This also includes design of studies, calculating of sample size
and power, writing statistical portions of protocols, review of
protocols and case report forms, support for research, physician,
and marketing requests, and assisting clinical teams with other
duties as appropriate
-Uses a variety of statistical methods and software tools to
analyze and display data.
-Methods must be appropriate for the kind of data collected, and
required assumptions must be tested
-Interprets statistical findings, and ensures that regulatory
submissions, reports, and manuscripts accurately reflect the data
collected
-Validates and provides clear documentation of analysis
programs
-Writes portions of Results and Methods sections of reports and
manuscripts
-Consults with colleagues on statistical and analysis issues
-Writes the statistical analysis plan for the study.
-Writes error-checking requirements for the study data
-Applies statistical knowledge to the design of clinical
studies.
-This requires calculation of sample size and power, as well as
solicitation of appropriate design assumptions from other staff and
from published literature
-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 teams to prevent, track, and manage potential
problems
-Assists study teams in responding to questions from FDA.
-Attends and contributes to project and department meetings
-Perform statistical program validation in accordance with
departmental Standard Operating Procedures
-Identify potential threats to study credibility and validity, and
work with study teams to prevent, track, and manage potential
problems
-Work with the information systems staff and the clinical study
team to develop specifications for the database design that assure
the quality, integrity, and timely availability of the data for
monitoring and analysis purposes
-Manage multiple, varying sized projects concurrently
-Work with cross-functional teams to develop and refine study
objectives to establish the safety and efficacy of medical device
therapies and diagnostics
-Participate in development and documentation of study protocols
with responsibility for scientific soundness sections, which
include statistical hypotheses, sample size calculations, and
analysis methods for meeting the study objectives, in
collaboration
-Perform analyses of study data including documentation and
justification of the statistical methods, analyses, and results in
clinical reports, abstracts, and manuscripts
-Respond to statistical questions from FDA/other regulatory
agencies
-Develop statistical programs (e.g., using SAS, S-PLUS, R, WinBUGS)
for data extraction, statistical analysis, and report
generation.
Required:
*Education Level: Master of Science
*Industry Experience: 1 - 3 Years
*Math Skills
*Oral Communication: Excellent
*Software Application Knowledge: SAS
*Written Communication: Excellent
Request Notes :
REQUIRED SKILLS/EXPERIENCE:
*MUST HAVE a MS in Statistics, Biostatistics, or related field with
7-11 years of experience in the design and analysis of clinical
studies or 4-8 years with a PHD, advanced programming skills in
SAS, knowledge of clinical trial methods and execution in a
regulated environment, demonstration of strong oral and written
communication skills, including experience presenting clinical
trial results and statistical methods.
JOB DESCRIPTION:
*Primary focus will be on the design and evidence dissemination of
clinical studies.
*Ensure clinical protocols and statistical methods meet sound and
efficient statistical and clinical trial methodologies.
JOB DUTIES:
*Work with cross-functional teams to develop and refine study
objectives to establish the safety and efficacy of medical device
therapies and diagnostics.
*Participate in development and documentation of study protocols
with responsibility for scientific soundness sections, which
include statistical hypotheses, sample size calculations, and
analysis methods for meeting the study objectives, in collaboration
with others.
*Stay current on clinical evidence landscape and oversee
dissemination efforts of abstracts, oral and poster presentations,
reports, and publications. Interact with FDA reviewers, especially
statistical, to negotiate appropriate study designs, to explain the
quantitative results of clinical studies, and to defend the
analytical approach.
*Actively participate with internal and external governing bodies
of clinical trials (e.g. Steering, Publications committees,
etc.).
*Mentor and train other statisticians in their job duties and
responsibilities.
*Remain current on state-of-the-art statistical methods useful in
clinical trial design and analysis and share knowledge within the
department.
*Lead development of policies and procedures for the department and
the statistics group.
*Perform statistical program validation of important endpoints in
accordance with departmental Standard Operating Procedures.
*Identify potential threats to study credibility and validity, and
work with study teams to prevent, track, and manage potential
problems.
*Review statistical analysis plans.
*Review case report forms and ensure consistency between the data
collected and the objectives of the study.
If you are interested in this opportunity and you qualify please
complete the following and send back with your updated resume.
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Requirement #: 45927-4678
Your resume in Word format along with your salary requirements to
rsanderson@keystonecs.com
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