Statistician 2

Confidential Company  •  Franklin Lakes, NJ

Less than 5 years experience  •  Medical Devices & Diagnostics

$110K - $180K
Posted on 11/28/17 by Green Lee
Confidential Company
Franklin Lakes, NJ
Less than 5 years experience
Medical Devices & Diagnostics
$110K - $180K
Posted on 11/28/17 Green Lee

Statistician 2

Franklin Lakes, NJ

12+ Months contract 

8.00 AM to 5 PM

Weekly 40.00 hours [Mon to Fri]

Qualifications of the Statistician 2

• 3+ years of experience in a regulated industry preferably with Medical Device and IVD trials is required with Master’s degree. 0+ years of experience in a regulated industry with device and/or healthcare industry is required with PhD.

·        Demonstrated competence in the application of statistical techniques used in clinical trials and product development is required.

·        Working knowledge of applicable regulations and the ability to apply without supervision is preferred.

·        Ability to program, document, and validate statistical code in SAS and/or R is required. Knowledge and experience working in a reproducible research environment is preferred.

·        Demonstrated capability of working on multiple projects at one time

·        Ability to complete deliverables on time and adjust priorities in a fast paced environment

·        Ability to work independently as well as collaboratively in a team environment

·        Strong verbal and written communications skills Master degreepreferred; Education and practical experience must be sufficient to contribute to study or studies with limited supervision. Preferrededucation/experience areas include Statistics, Biostatistics, or related field. Equivalent education or experience will be considered. 

Responsibilities of the Statistician 2

The Contract Statistician II position is to primarily provide statistical support for clinical studies conducted by Corporate Clinical Development (CCD) and for R&D, manufacturing, quality, marketing, and finance as needed. Clinical studies may range from simulated use studies (employing a clinician to use the device in a simulated environment) to complex studies in human subjects and/or specimens that may include devices, in vitro diagnostics (IVDs), drugs, or drug/device combinations. The CCD supports all BD business units.

·        Consult with project statistician, clinical and project teams, plan and analyze clinical or non-clinical studies; use statistical knowledge to support and guide business questions and to help facilitate strategic decision making for management and project teams.

·        Ensure statistically sound study designs including sample size estimation.

·        Prepare statistical analysis plans.

·        Prepare randomization schedules.

·        Perform statistical analysis according to a statistical analysis plan.

·        Program, document, and validate software code in R and/or SAS to execute data handling tasks, perform standard data analysis, and produce data visualization results.

·        Review and/or prepare formal written reports/documents for distribution within and outside the department.

·        Provide statistics deliverables for projects to meet schedules and goals for multiple businesses and platforms. Develop/revise work plans independently with occasional consultation with manager. 

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