Principal Statistician

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: Performs the lead statistician role, leading and contributing to the development and implementation of Statistical Analysis Plans, and providing statistical consultancy internally and externally to the company. RESPONSIBILITIES:* _Tasks may include but are not limited to:_ Provide review of study designs, analysis plans, and reports. Contribute to the design of clinical trials, including statistical sections of the study protocol, randomization methodology and writing Statistical Analysis Plans. Able to understand and advise on core components of study design and analysis. Provide support to the statistics reporting process through the specification/review of tables, figures, and listing shells, writing/review of derived dataset specifications, and the formatting of report documents and tabulations. Undertake and/or contribute to the preparation of final reports, including production of tables, figures, and listings and report writing. Develop, test, and run SAS programs for the statistical analysis of clinical study data. This includes programs for derived datasets, SDTM/ADaM datasets, tables, figures, and listings, and/or associated validation. Manage requests for ad hoc data summaries when requested during the course of a trial. Extract information from the system during the course of a trial e.g. summaries, data listings, study data sets Contribute to the identification of system and process improvements, and to the development and implementation of solutions to improve the efficiency and quality of clinical study data processing and reporting. May make statistical contributions to manuscripts for publication. Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are fully met by expert and timely statistical consultancy and support May provide consultancy, mentoring, and guidance to statisticians on statistical methodological issues during trial design and analysis. Perform all activities in compliance with WCT and agreed sponsor quality system standards, relevant ICH standards and specifically with FDA Quality System Regulation (including 21CFR Part 11). Liaise with internal departments, sponsors, and other third parties regarding statistical issues and reporting requirements Represent the function externally through attending and participating in external sponsor team meetings or meetings with external vendors/conferences. Apply department knowledge of the latest developments in statistical methods, regulations (in particular ICH, FDA, CPMP points to consider efficacy, safety and quality standards) and software applications. Contribute to the development of statistical design and analysis policies Review budgets and flag any out of scope or unbudgeted items, identify any tasks not in alignment wi

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