Job Description

12 Months Contract.

Qualifications:

The Contract Statistician position is to primarily provide statistical services for clinical studies conducted by Corporate Clinical Development (CCD). 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 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 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 and non-standard data analysis, and produce data visualization results.
•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.

Responsibilities:
•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.
•Ability to program, document, and validate statistical code in R and or SAS. Knowledge and experience working in a reproducible research environment is preferred. •Working knowledge of applicable regulations and the ability to apply without supervision 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 Bachelor degree required, Master degree preferred; Education and practical experience must be sufficient to contribute to study or studies with limited supervision. Preferred education/experience areas include Statistics, Biostatistics, or related field. Equivalent education or experience will be considered.