Principal Statistical Programmer

Job Description

40 + different analysis including clinical trials, scientific analysis, health authority responses, publication requests, patient access services, etc., are being worked upon at any point of time. The Statistical Programming team is a dynamic function where we are empowered to experiment, explore and progress beyond the boundaries of best-in-class Statistical Programming analysis. From a collaborative effort with Data Management, Clinical Study Teams, Statisticians, medical / scientific writing teams, publication teams, we analyze tons of data, deriving meaningful insights that enable us to deliver innovative medicines to millions of patients worldwide. Responsible for managing project level activities within Product Lifecycle Services (PLS). Act as the programming functional lead on customers project teams. Participate in project team meetings. Determine an efficient project programming strategy that utilizes customers standards and procedures. Develop project-level programming specifications for analysis datasets and pooled datasets for a project. Lead the production of statistical outputs for clinical study reports, publications, and market promotions. Ensure the quality control of all programs, specifications and statistical outputs within a study project. Ensure that programming-related documents are consistent, and comply with Data Sciences and customers standards, by reviewing case report forms, statistical analysis plans, data structures specifications, and specifications for tables, listings and figures. Archival of project programs and associated documentation. Mentor programmers in the functional expertise required for project support. Support the development of, and the training of users in, new programming applications. As required, participate in process improvement initiatives or other non-clinical project activities. Develop advanced, general-purpose programming functions for deployment across multiple projects. Maintain advanced knowledge of programming languages (e.g., SAS and R). Manage the outsourcing of programming activities from Data Science to an approved vendor in accordance with Scientific Services vendor management procedures. Assist the Group Lead in the assessment of applicants for programming roles within Data Science.Minimum requirements Graduation/Post graduation or equivalent experience in mathematics, statistics, computer science, or health sciences/related field with 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). Advanced knowledge of / experience with SAS, or R, and other relevant programming software. Proven experience in development of advanced programming functions 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) . Proven 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. Good Clinical Practice). Good knowledge of office tools.Why Novartis 769 million lives were touched by Novartis medicines in 2020, and while we re proud of this, we know there is so much more we could do to help improve and extend people s lives.We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent whats possible, when we collaborate with courage to aggressively and ambitiously tackle the world s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!Imagine what you could do here at Novartis!Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team s representative of the patients and communities we serve.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network,

Keyskills :
sassas programmingsdtmdata managementreportingcase report formsstatistical analysis plansprocess improvement initiativesdata sciencestudy reportsquality control