Statistical Programmer

Responsibilities:

• Convert study design and specifications into programs to support clinical trials.
• Validate SAS programs written by others.
• Assists Management in maintaining SOPs and work instructions relevant to SAS programming.
• Follow regulatory requirements and guidelines for the development, usage, and maintenance of programs to support regulatory submissions.
• Disseminate the programming activities for a clinical trial to a junior level.
• Write and maintain documentation to describe program development, logic, coding, testing, and updating.
• Support departmental archiving of computer programs, data, and documentation.
• Create and execute SAS programs to extract data from databases and create analysis.
• Convert external data to SAS datasets for internal use.
• Design robust, flexible, and modular macros for projects.
• Perform integration testing of software and validation.
• Interact with other functional areas to resolve issues pertaining to duties assigned or requested technical consultation.

Requirements:

• BS or BA Degree in Computer Information System, Computer Science, Mathematics, Statistics, or a related field.
• 5 years of SAS programming experience in scientific/research field, 3+ years of experience in supporting regulatory submissions.
• In-depth knowledge of CDISC SDTM, ADaM, Define.xml, CFR 21 Part 11 compliance, ICH and FDA standards preferred.
• Strong knowledge of BASE/SAS, SAS Macros, ODS and SAS/Graph in a Windows SAS environment.
• Knowledge of data manipulation, report generation in support of regulatory submission.
• Understanding of data and system dependencies, validation techniques, and integration of studies for ISS/ISE.
• Knowledge of the Software Development Life Cycle (SDLC) and methodologies.
• Knowledge of MS-Office.