The SAS Programmer is responsible to support the Senior and Principle SAS programmer on 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. This role provides expertise in SAS programming and related processes to the Biometrics group, and requires working knowledge of CDISC SDTM, ADAM, Define.xml structures and standards, as well as working knowledge of ICH and FDA guidelines on data and reporting standards.
* Generate and validate tables, listings, and figures per protocol and statistical analysis plan and for ad-hoc requests. * Validates SAS programs written by others. * Assists management in maintaining SOPs and work instructions relevant to SAS programming. * Follows regulatory requirements and guidelines for the development, usage, and maintenance of programs to support regulatory submissions. * Responsible for the on-time and accurate completion of duties assigned. * Writes and maintains documentation to describe program development, logic, coding, testing, and updating. * Supports departmental archiving of computer programs, data, and documentation. * Creates and executes SAS programs to extract data from databases and create analysis-ready SAS datasets. * Converts external data to SAS datasets for internal use. * Assist in designing robust, flexible, and modular macros for projects.
BS or BA Degree in Computer Information System, Computer Science, Mathematics, Statistics, or a related field.
5 years of SAS programming experience in life sciences or medically related environment.
* Working 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 MS-Office (i.e. Word, Excel and PowerPoint) * Technical writing skills adequate to prepare effective documentation for programs and contribute to SOP development. * Effective interpersonal skills in collaborating with teams composed of individuals with widely diverse backgrounds, skill levels, and organizational levels.
About Mallinckrodt Pharmaceuticals
Mallinckrodt is a business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies.