The Principal Programmer is responsible for the design, execution and quality control of computer programs to produce statistical outputs for customers' individual, and project groups of, phase I-
IV clinical trials, the provision of programming consulting services, the training and mentoring of other programmers, and supporting project operational excellence.
1.Responsible for managing project level activites within Product Lifecycle Services (PLS).
2.Act as the programming functional lead on customers' project teams. Participate in project team meetings.
3.Determine an efficient project programming strategy that utilizes customers' standards and procedures.
4.Develop project-level programming specifications for analysis datasets and pooled datasets for a project.
5.Lead the production of statistical outputs for clinical study reports, regulatory submissions (e.g., Summary of Clinical Safety, Summary of Clinical Efficacy, Risk Management Plan / safety update), responses to health authority questions, publications, and market promotions.
6.Ensure the quality control of all programs, specifications and statistical outputs within a study project.
7.Ensure that programming-related documents are consistent, and comply with Data Science's and customers' standards, by reviewing case report forms, statistical analysis plans, data structures specifications, and specifications for tables, listings and figures.
8.Archival of project programs and associated documentation. 9.Mentor programmers in the functional expertise required for project support.
10.Support the development of, and the training of users in, new programming applications.
11.As required, participate in process improvement initiatives or other non-clinical project activities.
12.Develop advanced, general-purpose programming functions for deployment across multiple projects.
13.Maintain advanced knowledge of programming languages (e.g., SAS and R).
14.Regularly elicit customers' satisfaction levels with Data Science's programming services. Identify service areas requiring attention.
15.Encourage customer participation in the PLS customer satisfaction (CSAT) survey.
16.Manage the outsourcing of programming activites from Data Science to an approved vendor in accordance with Scientific Services vendor management procedures.
17.Assist the Group Lead in the assessment of applicants for programming roles within Data Science.
BA / BS / MS equivalent experience in mathematics, statistics, computer science, or health sciences / related field. Fluent English (oral and written)
1. Advanced knowledge of / experience with SAS, or R, and other relevant programming software.
2. Proven experience in development of advanced programming functions with high programming efficiency; strong programming and problem-solving skills
3. Proven experience in leading programmer support for multiple clinical trials and submission activities (or equivalent)
4. Working knowledge of database design / structures and basic statistics. Working experience in pooling analysis datasets across multiple clinical studies (or equivalent)
5. Good understanding of global clinical trial / project practices, procedures, methodologies.
6. Good understanding of regulatory requirements relevant to statistical programming (e.g. Good Clinical Practice).
7. Intermediate knowledge of office tools.
8. At least 8 years work experience in a programming role preferably supporting clinical trials / or in the pharmaceutical industry (5 years for MS Statis