Principal Statistical Programmer

hace 4 días

Madrid, España Worldwide Clinical Trials, Llc A tiempo completo

.Who we areWorldwide 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 WorldwideWe 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 usWhat Global Programming does at WorldwideThe 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 doServe 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 standardsDevelop 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

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