Contract duration: 12 Months
This position is responsible for developing, planning, and implementing statistical and SAS programming in Global Clinical Affairs projects in accordance with good scientific principles and pertinent government regulations to support clinical study reporting and scientific publications.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
· Develop SAS programs that are accurate, efficient, and well documented.
· Prepare data validation and accurate statistical analysis data sets for analysis
· Ensure accuracy of statistical tables,data listings, and report text
· Perform sample size/power calculations
· Author statistical analysis plans
· Assist the preparation of clinical development plans from a data management and analysis perspective, including strategic input into research programs
· Support study team on clinical trial design and statistical/regulatory issues
· Assist in development of clinical trial protocols, randomization schedules, and in performing associated database-related activities
· Assist with the design and review of case report forms
· Leverage knowledge of data sets to assist in query identification and resolution in clinical studies
· Assist in the development of analysis and presentations to internal/external customers that are based on clinical data
· Clearly communicate basic statistical concepts to other scientists and nonscientists
· Provide mentoring as needed to non-statistical peers with regarding to basic statistical methodology
· Exercise sound decision making by escalating important items to supervisor and/or other relevant parties in a timely manner.
· Assist in SOP development
· Perform other responsibilities as assigned
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
TOOLS AND EQUIPMENT USED
· Telephone, computer linked to local area networks, and copy machine.
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
ADVERSE WORKING CONDITIONS
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.
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