Senior Statistical Programmer 2

Worldwide Clinical Trials2 LocationsonsiteSalary not postedView the original posting at Worldwide Clinical Trials ↗

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. 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! *SUMMARY: To perform the lead programming role, lead continuous improvement in the programming function's operating systems and provide consultancy across the function* *RESPONSIBILITIES:* _Some team members may focus on a limited number of these responsibilities depending on requirements. __Tasks may include but are not limited to:_ Develop, test and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures and listings (TFL). Perform review and provide guidance on the development of the clinical database specification, data transfer agreement/specification, specification of tables, figures and listings (TFL) shells. Develop and review specification for SDTM datasets and ADaM datasets for safety data, TFL shells and other specifications, e.g. patient profiles, OPS reports. Develop and review electronic data submission package (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide) for high complexity studies. 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. 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 and competing project priorities effectively. Ensure budget and scope of project work remain aligned. Manage the study documentation flow as per Worldwide SOP and other procedural documentation including timely document submission to eTMF. Be able to describe and explain Worldwide documentation and eTMF requirements. Actively seek, propose and lead process improvement initiatives including development of standard SAS Macros, in-house programming standards. Participate in development of department SOPs, guidelines, templates and other quality management documentation. Provide training and consultancy to Clinical Data Managers, Statistical Programmers and Biostatisticians on programming, clinical and analysis data standards (CDISC) and electronic data submission requirements. 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. Develop knowledge of SAS (including BASE, GRAPH, MACRO, ODS, SQL) and other software applications (e.g. Excel, Visual Basic, Word). Develop regulatory standards knowledge in compute

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