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Position Description
To participate in the planning, implementation and coordination of the
design of protocols, case report forms, and clinical procedures for the
efficient data collection, management and evaluation of clinical studies
conducted by the business unit, and to execute the analysis of data from
these studies. To participate in the documentation of the study results in
clinical reports for various regulatory submissions. To participate in the
preparation of abstracts, oral and poster presentations, and publications
relating to the study results. To ensure that clinical studies are conducted
and data analyzed in accordance with good clinical practices
Position Responsibilities
Work with the Coronary and Renal Denervation business unit’s clinical and
project teams to develop and refine study objectives to primarily establish
safety and efficacy, and secondarily, quality of life and cost-effectiveness
related data for clinical trials. Participate in the development of the
study protocol with primary responsibility for statistical hypotheses,
sample size, and analysis plan for meeting the study objectives. In
collaboration with the management team, , select appropriate study design
for optimal power, hypotheses, endpoints, critical differences, procedure
specifications for clinical evaluation. Further, to estimate baseline
endpoint rates in the control group through literature review, analysis of
historical data, or gathering of expert opinion to generate sample sizes and
follow-up times to meet study objectives. In addition, to choose analysis
plans, and determine whether fixed-sample or sequential analyses will be
used. To specify stratification variables and covariables for adjustments,
analysis times, data monitoring specifications, and analyses of additional
performance measures.
Participate in the design of case report forms to ensure data validity and
usefulness, and to assist with the development of the core clinical
procedures of the study protocol to ensure the ascertainment of the
quantitative data requirements of the study.
Work with the statistical programming team to develop specifications for
the database design that assure the quality, integrity, and timely
availability of the data for monitoring and analysis purposes, and to
specify the criteria for the error-checking report in regard to the
quantitative accuracy of accumulating data. Review data monitoring reports
executed by the associate statistician for the purpose of developing an
appropriate corrective statistical action plan. To participate in
formulating corrective action whenquality problems are found. To assure that
the data are consistent, accurate, and complete before presenting analyses
by measuring data quality frequently and by choosing appropriate methods for
data monitoring with review by other statisticians. To interact regularly
with the clinical project team and other statisticians to discuss results of
monitoring, study status and schedule, and to plan future activity.
Perform and justify the final analyses of study results including
documentation of the statistical methods, analyses, and results in clinical
reports for internal purposes and various external regulatory submissions.
This includes interpreting the quantitative results of the study and
documenting the statistical conclusions of the study.
Participate in the preparation of abstracts, oral and poster presentations,
and publications relating to the results of clinical studies. To respond to
requests from clinical study investigators for statistical support with
study design and data analysis. To interact with the clinical study
investigators to determine optimal approaches for analyzing and interpreting
data for publication and presentation.
Participate in the business unit’s operational effectiveness efforts to
improve the efficiency of study conduct, data management, and data quality
processes in clinical studies.
Interact with FDA reviewers to negotiate optimal study designs, to explain
the quantitative results of clinical studies and to defend the analytical
approach and interpretation of models used.
Basic Qualifications
Minimum: M.S. in Statistics, Biostatistics or related field.
At least 4 years of experience in the design and analysis of clinical
studies in medical device, biotechnology, or pharmaceutical, industry with
a M.S degree, or 1+ years with a Ph.D. degree. Comprehensive knowledge of
statistical methodology, clinical trials methodology, regulatory
requirements, and statistical software packages, including SAS. 2+ years of
experience working with SAS programming (V. 6.12 or higher) in SAS BASE and
STAT packages.
Ability to communicate statistical information to non-statisticians.
Knowledgeable in the therapeutic area of the business unit. Good oral and
written communication skills. .
Proficient in Microsoft Office (WORD, EXCEL, and POWERPOINT).
Desired/Preferred Qualifications
Good interpersonal skills
Physical Job Requirements
Telecommuting possible for this position.
•The physical demands described within the Responsibilities section of
this job description are representative of those that must be met by an
employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required
to be independently mobile. The employee is also required to interact with a
computer, and communicate with peers and co-workers. | w******a
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