Principal/Senior Programmer

A premier, global specialty pharmaceutical and medical technology company is seeking a Principal/Senior Programmer - SAS in Santa Barbara, California!

 

JOB SUMMARY:

 

Under general guidance will provide advanced level of SAS programming activities for the monitoring, reporting, and analysis of clinical trials and will deliver against the overall protocol timelines and quality goals within the study teams.

 

REQUIREMENTS:

 

- Bachelor's or Masters in Computer Science or other relevant degrees with 5+ years of pharmaceutical experience preferred

- The work experience should include at least two years of technical leadership in a statistical programming environment in a pharmaceutical or biotechnology environment including the analysis and reporting of clinical trial data

- Knowledge and application of p-values, confidence intervals, linear regression analysis, advanced general linear models, frequencies, survival analysis, non-parametric analysis, randomization software, proficiency in implementing these ideas in clear, efficient SAS code for the purposes of data analysis and reporting.

- Accountable for overall timelines and major project milestones, as well as overall project quality, integrity and productivity

- Knowledge of base SAS, SAS macro language, graph, FSP, STATS, SQL as well as other programming languages.

- Knowledge of UNIX system, Oracle Clinical and EDC (electronic data capture) exposure preferred

- Knowledge of clinical systems, medical terminology, clinical trail methodologies, and software systems development.

- Excellent analytical, problem solving, and computer skills.

- Flexible, well organized, excellent verbal and written communication skills, and interpersonal skills.

- Works well under pressure, with initiative to take on unfamiliar tasks

- Basic knowledge of FDA/ICH guidelines, the software development life cycle, and 21 CFR Part 11 and other FDA regulations. 

- Experience working on FDA submissions. 

- Leadership, communication and project management skills required

- Demonstrated ability to operate independently 

- Able to give effective presentations to small groups such as Implementation Teams or Statistical Programming meetings

 

KEY DUTIES AND RESPONSIBILITIES:

 

- This position has no direct supervisory responsibility, however will provide direction and leadership to employees assigned to project teams and provide input on their performance

- Collaborates with project biostatistician in the creation, implementation, and maintenance of execution plan accounting for timeline, resource and quality of the projects.

- Ensures that all statistical programs comply with the programming coding standards and utilize available standard reporting systems, as well as macro utility programs.

- Will support statistical programming applications that are used to generate clinical study reports.

- Support ADS and TLG generation, and assist with the development of work flow and SOPs for Biostatistics and Statistical Programming operations.

- Accountable for the provision of standard and non-standard data sets, tables, listings and figures based on the final synopsis and SAP that are required for the study reports, submissions and product defense.

- Delivers against the overall protocol timeline within the Study Team

- Communicates effectively not only within the teams and functional lines but also with the external resources

- Provides filing, approval and regulatory programming support for all aspects of a submission