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.