Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality.Anchored in our company's scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers. Our talented team of 3,000+ professionals spans 60+ countries.We are united in cause with our customers to improve the lives of patients through new and innovative therapies. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us! What Global Programming does at Worldwide The Worldwide team is an experienced and diverse group of Programmers who collaborate together as one, both via regularly scheduled group meetings to discuss issues, and impromptu one-on-one discussions between colleagues to discuss a particular topic. As the Principal Statistical Programmer, you will lead and own continuous improvement in the programming function's operating systems and provide both technical and project consultancy across the function on a project. What you will do Serve as a programming project lead on multiple complex studies (e.g. adaptive design, integrated safety/efficacy study) to distribute and oversee tasks for the programming team, communicate with internal and external clients, plan and execute delivery, and manage resources, competing project priorities and client's expectations effectively. Ensure budget and scope of project work remain aligned. Apply advanced knowledge of CDISC standards and electronic data submission (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide, Analysis Results Metadata). Provide expertise and consultancy on FDA, PMDA and other regulatory agencies submission requirements. Take full ownership of department process improvement projects and initiatives including development of standard SAS Macros, in-house programming standards Develop and provide Statistical Programmers, Biostatisticians and representatives of other departments and groups with training and coaching on the Biostatistical Operations department process, infrastructure and tools, collaboration with other internal and external parties and the role of the statistical programmer. What you will bring to the role Must be computer literate and numerate with a willingness to adapt to various computer systems. Hands-on expert level project statistical programmer experienced in providing programming leadership to projects. Statistical programming skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change. The job holder must have a depth of expertise across all statistical programming skills and consistently display a positive attitude and considered as a global role model. It is essential that the job holder to possess strong analytical skills and attentiveness to detail. Expert in upstream (Data Management) and downstream (Medical Writing, regulatory submission) processes. To have the ability to train new staff and to monitor their performance. Your experience University Degree or equivalent (post-graduate degree is preferable, but not mandatory). Advanced SAS programming skills with expert knowledge in SAS/Macro, Proc Report and ODS. Good working knowledge in SAS/Graph, Proc SQL, SAS/STAT. Previous experience in process improvement, development and deployment of innovation. Why Worldwide We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page atwww.worldwide.com/careers!For more information on Worldwide, visitwww.Worldwide.comor connect with us onLinkedIn.
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