The Senior SAS Programmer Analysts play a key role developing and executing statistical programs designed to analyze clinical trial information. The Senior SAS Programmer Analyst will be responsible for designing and developing standard software and data structures, developing and executing statistical programs designed to analyze clinical trial information and participating in the development and maintenance of SOPs (including software validation, documentation, study archiving and others as needed). This position can be located at facility in Warrington, PA or Raleigh, NC or be home based anywhere in the US.
Develop and execute statistical analyses of clinical trial data. Design and develop computer programs that produce tables, figures, listings and derived datasets that summarize results of clinical trials.
Participate in the review of Case Report Forms (design phase), Statistical Analysis Plans, QC Specifications and Database Structures.
Assess data from clinical trials for consistency and accuracy.
Develop and implement quality assurance software.
Ensure accuracy of all results and provide appropriate documentation.
Design and write standard maintainable, supportable, well- documented computer programs that are user-friendly and accessible.
Design and implement analysis file structures.
Review software written by programmer analysts in the department for accuracy and efficiency.
Monitor procedures for software validation.
Work on cross-disciplinary teams to assure programming needs are met and appropriate requests are made.
Provide technical support to SAS users
Must have vaccine experience
· Minimum 6 years full time SAS programming experience in the clinical research arena. To clarify, Stat Programming, not DIS
· Minimum 6 years producing Analysis Data Sets and Tables, Listings & Figures (TLF)
· Experience in ADaM datasets and CDISC standards
· Understanding of data structures, standard software and their implementation.
· Knowledge of the drug development process (Phase I through IV) and general regulatory requirements.
· Demonstrated leadership skills as well as ability to work independently and on a team.
· Ability to serve as department representative at cross-functional meetings.
· Good written and verbal communications skills.
Lead Programmer Requirements
Additionally, right now we are only seeking candidates that have significant lead experience. In a Lead Programmer role time will be split approximately 50/50 between “leading” and statistical programming. Having said this, there are project which require more time spent in the lead capacity role. Lead Programmer responsibilities include the following key elements and we are seeking candidates that possess experience in these:
· Plan, track and coordinate all project activity
· Attend cross functional meetings surrounding assigned studies
· Interact with the client on a regular basis
· Supervise the work of 4 or more SAS Programmers assigned to the project building analysis data sets and TFLs
· Review and QC for accuracy the work of SAS Programmers assigned to the project
· Act as point person for the project
· BS degree in a quantitative discipline (or training equivalent to) or equivalent work experience.
Full Time Salary and Benefits with a Fortune 500 company