Job Title: Statistical Submissions Management Senior Analyst III
Location: Cambridge, MA
Company: Radiant Info Systems
Contract: Duration: 12 months
Radiant Info Systems is looking for a Statistical Submissions Management Senior Analyst III for its Cambridge, MA office.
• Coordinating, preparing, reviewing and managing Biostatistics electronic submission ready components for complex regulatory submissions
• Monitoring and meeting assigned project milestones and requesting resources while providing adequate submission status tracking reports, as well as metrics reports, to communicate progress and trends of electronic submission activities (i.e. submissions plans)
• Developing or implementing standard electronic submission practices and standards, while also ensuring that they are employed across studies and drug programs
• Providing submission support to complex ad-hoc and response requests from regulatory agencies
• Able to handle a large volume of highly complex tasks and work effectively under pressure and tight deadlines
• Able to use SAS programming software intensively and to review SAS programs and prepare the submission components
• Must have experience with clinical trial data and software used for electronic submissions purposes
• Must have great general computer proficiency, including Microsoft Suite applications
• Must have 5-10 years Adobe Acrobat and electronic submission applications experience utilized for electronic submission purposes
• Must have 5-10 years SAS experience with some demonstrated programming language experience
• Must have 5-10 years relevant experience in the pharmaceutical, biotechnology industry or CRO
• Must have a demonstrated ability in supporting project teams and management
• Must have extensive knowledge and application of applicable industry principles, concepts, techniques, and standards
• Must have full knowledge of applicable regulations and industry practices and ability to utilize the knowledge in the practice
• Must have excellent application of concepts and principles of electronic submission and drug development process
• Must have a Bachelor’s degree or equivalent, preferably in a scientific discipline (i.e. Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.)
To apply, please send your MS Word resume along with salary requirements to:
An equal opportunity employer, m/f/d/v.
Please reference BioTechPharmJobs.com when responding.