A leading Pharmaceutical company has a need for a SAS Programmer, with the option to work from home 2 days a week.
The SAS Programmer is responsible for providing technical leadership in Biometrics Group and 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. This role provides expertise in SAS programming and related processes to the Biometrics group, and requires a significant 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. The Principal SAS Programmer acts as lead programmer for one or more projects. 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.
- Converts study design and specifications into programs (tables, figures, listings) to support clinical trials.
- 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.
- Disseminates the programming activities for a clinical trial to more junior level, or project team personnel.
- 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.
- Designs robust, flexible, and modular macros for projects.
- Performs integration testing of software and validation.
- Assist in timeline set up and ensures that programming activities are implemented consistently across clinical studies
- Interacts with other functional areas to resolve issues pertaining to duties assigned or requested technical consultation.
- Contributes to requirements specifications for external vendors and consultants and may oversee their work.
- Conducts oversight management of vendors assessing the quality of clinical trial information (i.e. data sets, tables, listings, graphs, etc) provided to the Biometrics Department in support of clinical trial submissions to a regulatory authority. May be required to participate in audits of external vendors
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, with a minimum of 3 years of experience in supporting regulatory submissions (NDA, BLA, IND, BA\BE or Global Equivalents).
- 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 (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