Principal Statistician - UK/Europe

Who we areWe’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 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 us!

What the Biostatistics Department does at Worldwide

As an individual on our Biostats and Statistical Programming team, your programming, analytical skills, and ability to process and interpret data are the keys to success. At Worldwide, you’ll be able to grow your knowledge of SAS and CDISC standards across all phases of clinical trials. You’ll work directly with multiple sponsors, data managers, statisticians, statistical programmers, and the wider study team across a variety of therapeutic areas including cardiovascular, metabolic, neuroscience, oncology & rare diseases. When you work here, you have the autonomy to do your work through hands-on involvement, the support you need to succeed and grow, and the realization that, here, your work really does matter.

What you will do

• Provide review of study designs, analysis plans, andreports.Contributeto the design of clinical trials, including statistical sections of the study protocol, randomizationmethodologyand 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.

• 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.

• Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are fully met by expert andtimelystatistical consultancy and support

• 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 partiesregardingstatistical issues and reporting requirements

• Apply department knowledge of the latest developments in statistical methods, regulations (in particular ICH, FDA, CPMP points to consider efficacy,safetyand quality standards) and software applications

• Review budgets and flag any out of scope or unbudgeted items,identifyany tasks not in alignment with current scope of work.

Wha...