Sr. Manager, Programming Ambit Biosciences
The Sr. Manager of Programming provides statistical programming technical leadership and support to team members including programming outputs (datasets, tables, listings, figures, compliance and oversight documentation) for protocols, product defense, and commercial support. They also provide expertise in clinical programming, partnering with internal and external groups to ensure quality and compliance in clinical programming deliverables.
Essential Job Functions:
?Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project
?Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic submissions of data with minimal instruction or input from supervisor
?Provides guidance on the resolution of highly complex clinical trial reporting problems within budget and time line constraints, while assuring high quality standards
?Performs quality control checks of advanced SAS code
?Responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry
?Make certain that documents and specification are consistent and comply with company standards by providing input into study protocol, CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities
?Maintain records for all assigned projects and archiving of trial/project analysis and associated documentation
?Participate in the selection of CROs and supervise the trial activities of the CROs
?Provide input on process improvement initiatives and participate in non-clinical project activities
?Manages project timelines and schedules of specific phases of projects and contracts with internal personnel and outside customer representatives
?Other projects as assigned
EDUCATION:B.S. in a math or science related field
EXPERIENCE:Minimum of five (5) years of relevant experience w/SAS in the pharmaceutical industry. Oncology experience preferred.
COMPETENCIES AND SKILLS:?Proven record of effective and successful project management tasks and skills
?Good understanding of global clinical trials practices, procedures, methodologies
?Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
?Demonstrates advanced knowledge of electronic submissions and CDlSC
?Displays highly advanced knowledge regarding software validation and system development life cycle concepts
?Communicates effectively in verbal presentations and written technical reports to both internal and external customers
TECHNICAL KNOWLEDGE:Equipment: PC, scanners, facsimile machine, voice mail and email systems, and other common machines. Must have the ability to be trained on new equipment.
Software Knowledge:SAS, Windows, MS Office (Outlook, Word, Excel, PowerPoint), and Adobe.
ENVIRONMENTAL CONDITIONS:Physical Activities: While performing the duties of this job, the employee is frequently required to sit at desk for a long period of time; intermittently answer the telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The employee may need to use their hands to finger, handle, or feel objects, tools, or controls, and reach with their arms. The noise level in the work environment is usually low to moderate. The vision abilities required by this job include close vision and the ability to adjust focus.
The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
||4215 Sorrento Valley Boulevard |
San Diego, CA 92121