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ProClinical is currently seeking a Principal SAS Programmer for a global specialty pharmaceutical company. The SAS Programmer is responsible for providing technical leadership to the Biometrics Group and to assist in improving the processes related to programming and reporting. This individual is also responsible for designing, developing, validating, and maintaining data sets, reporting, general purpose and ad hoc SAS programs used in the support of regulatory submission of clinical trials, or internal decision making relative to clinical trial conduct. The Principal SAS Programmer may also assist in developing strategies and methodologies for ensuring that all programming is accurate and complies with regulatory requirements and helps develop appropriate SOPs for the programming and other departmental processes.

Job 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.

Skills and Requirements

BS or BA Degree in Computer Information System, Computer Science, Mathematics, Statistics, or a related field.
10 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.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Anula Aboobacker

at (+1) 646-367-2909 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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