Biostatistician - USA

United States
16 May 2019
15 Jun 2019
Stephanie Maccioni
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Stephanie Maccioni is engaging in a project with a global medical device company to appoint a Biostatistician. This role is offering employment on a long term contract basis, based out of the States.

The main purpose of the role will be to:
-Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.
-Design and execute statistical plans independently for all phases of clinical studies, assuming a leadership role in creating strategy for study design and analyses.
-Review clinical study protocols and Case Report Forms (CRFs) for proposed studies with respect to statistical methodology.
-Generation of randomization schemes; supervise unblinding of treatment assignments and appropriate handling of unblinded information.
-Review and assess protocol deviations to the extent that they affect statistical analyses.
-Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions.
-Contribute to peer-reviewed articles independently, in coordination with the lead author/physician.
-Review articles on topics relevant to specified products and provide reports concerning issues relating to statistical methodology.
-Assist with preparation of documentation for IRB/Ethics Committee submissions.
-Act as a statistical consultant to the business units and external customers on statistical issues.
-Interface with surgeons to assist in drafting peer-reviewed journal articles.
-Participate in vendor evaluation, selection, contracting, and oversight for statistical and programming deliverables.
-Provide statistical reports for data quality/performance metrics.
-Assist Clinical Research with literature reviews and other activities.
-May assist in presenting information at professional meetings.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-A Master's or Ph.D degree in Statistics, Biostatistics, or Applied Mathematics.
-Demonstrated technical experience in preparing statistical deliverables on time.
-Thorough understanding of descriptive statistics, power/sample size analysis, hypothesis testing, parametric, non-parametric, and multivariate statistical tests is required.
-Ability to assist in selecting and defining independent and dependent variables in the field of application is preferred.
-Ability to contribute to strategic planning

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45533 in all correspondence.