Novartis

The Principal Programmer is responsible for all programming aspects (including analysis datasets, pooled datasets, listings, figures, and tables) of individual Phase I-IV clinical trials and project-level activities for a drug project, provide technical expertise to offer consulting, training and mentoring other programmers and supporting operational excellence by working together with the statistical scientist and the biometrician. Responsible for the integrity of the programming/computing solutions for a global clinical drug development program.  Act as the scientific lead for programming expertise liaising with the Biometrician and statistical scientific counterparts within the team for a drug project.  Lead the full execution of final production output generation of quality, timely programming deliverables for CSRs, regulatory submissions/interactions, publications, and market promotions within the drug development program globally.  In conjunction with the Biometrician/Statistical Scientist, develop the project-level programming standards and ensure compliance with project-level/disease-area/company standards. As required, provide support to development of disease-area programming standards, following internal guidelines.  Ensure that documents and specifications are consistent and comply with company standards by providing input into eCRFs and data structures, tables, listings and figures for Phase I-IV clinical trials and submission activities within the responsible drug project.  Lead/program (according to established specifications) analysis datasets, pooled datasets, listings, tables, figures, and listings for Phase I-IV clinical trials and for regulatory submissions (e.g., SCS, SCE and RMP/safety update) and for other project support (e.g. publications and market promotion) according to established milestones.  Responsible for the preparation of Case Report Tabulations for the submission as required.  In consultation with the Biometrician/Statistical Scientist, responsible for development/update of project-level programming specifications of analysis datasets and pooled datasets (e.g. in RAP, MAP and CSPD) for the clinical drug project.  Ensure QC compliance and responsible for project records including archiving of programming and associated documentation. Responsible for quality control and audit readiness of quality programming deliverables for the drug project.  Assume the role of subject matter expert / trial domain expert to ensure seamless outsourcing, according to the agreed contract and internal business guidance.  Mentor/coach programmers in functional expertise and process for project support; as required, support training/development of new programming applications.  As required, participate in process improvement initiatives or other non-clinical project activities.  Develops advanced MACROs for general use of programmers.  Key Performance Indicator(s)  Problem solving and solution oriented; programming representation in the Clinical Project Team and IIS project team.  Internal and external satisfaction with final programming outputs used for the Clinical Project Development Program as assessed by customers, IIS project team/Project Lead/ Program Head.  Effectiveness of communication and team behaviors as assessed by the other members of the Clinical Project Team and IIS project team.  Quality and timeliness of programming contributions as assessed by the Clinical Project Team, IIS project team/Project Lead/ Program Head.  Ability and effectiveness in training and mentoring programmers in the IIS project teams. Minimum requirements BA/BS/MS equivalent experience in mathematics, statistics, computer science, or health sciences/related field.  Fluent English (oral and written)  Advanced knowledge of / experience with SAS and other relevant programming software.  Proven experience in development of advanced MACROs with high programming efficiency; strong programming and problem-solving skills  Proven experience in leading programmer support for multiple clinical trials and submission activities (or equivalent)  Working knowledge of database design/structures and basic statistics. Working experience in pooling analysis datasets across multiple clinical studies (or equivalent)  Good understanding of global clinical trial / project practices, procedures, methodologies.  Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).  Intermediate knowledge of office tools.  At least 8 years work experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry (5 years for MS Statistics / Computer Science graduates).