Franklin Lakes, NJ
Industry: Medical Devices & Diagnostics•
Less than 5 years
Posted 379 days agoby Green Lee
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.