Job Title: Clinical Statistical Assistant (Temporary - 12 months)
FLSA Status: Non-Exempt
Job Number: 03500408
Department: Clinical Development
Description: The Clinical Statistics Assistant will carefully review all clinical trial statistical datasets, programs, and associated files for legacy and ongoing trials. The Assistant will be responsible for coordinating the transfer of any missing items from CROs and laboratories to Arena, and in conjunction with other Arena Staff, will assure that the items are formatted and filed in eCTD-ready form. The Assistant may also assist with the compilation, review and filing of internal Arena clinical and statistical documents in support of all development programs. The position is part-time and temporary, with an initial term of 12 months.
Essential Duties and Responsibilities:
- Perform review and gap analysis of all clinical statistical files and documents required for NDA submission;
- Coordinate acquisition of missing files and documents;
- Responsible for formatting and filing the files and documents in eCTD-ready form;
Job Requirements:
Education: Minimum - some college; will consider candidates with Bachelor's or Master's degree.
Experience: Basic familiarity with SAS data, some programming, or with electronic data management systems, and/or with clinical trial environments is a plus. As a minimum, candidate must be familiar with electronic datasets and electronic file systems.
Specific Skills:The candidate will be reliable and highly organized with attention to detail. The candidate will be proficient with electronic file structures, and may have some background in programming. The candidate should have good interpersonal skills and should enjoy working in a fast-paced team environment.
Supervisory Responsibilities: None
Physical Demands/Work Environment: 80-90% of work day spent working at a computer or performing paperwork at a desk. Physical labor will not be required; lifting will be limited to items no heavier than reams of paper. Moving about the company will require walking between buildings, representing distances of ~1/8 mile or less.
