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!
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, 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.
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 and timely statistical 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 parties regarding statistical issues and reporting requirements
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
Review budgets and flag any out of scope or unbudgeted items, identify any tasks not in alignment with current scope of work.
What you will bring to the role
Must be computer literate and numerate with a proven ability to adapt to various computer systems; thorough knowledge of SAS; knowledge of other software applications a plus
Consultancy and facilitation skills are required together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating, and influencing, embracing innovation and change.
Your experience
Appropriate degree and minimum relevant experience: (BSc/8 years, MSc/6 years, PhD/4 years)
Hands-on expert level project statistician experienced in providing statistical leadership to projects.
Experienced in a broad range of statistical applications across all phases of clinical research with a thorough knowledge of regulatory standards and exposure to regulatory interactions.
Good oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in English
Ability to prioritize and handle multiple projects simultaneously, a flexible approach, the ability to use sound independent judgement and take initiative to assess information.
Experience across multiple therapeutic areas
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 at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
Skills Required
- Thorough knowledge of SAS
- Experience with CDISC standards and creation of SDTM/ADaM datasets
- Ability to develop, test, and run SAS programs for analyses and reporting
- Appropriate degree with minimum relevant experience (BSc/8 years, MSc/6 years, PhD/4 years)
- Hands-on expert-level project statistician with statistical leadership experience
- Thorough knowledge of regulatory standards (ICH, FDA) and exposure to regulatory interactions
- Strong consultancy, facilitation, communication and stakeholder influencing skills
- Good oral and written communication in English
- Ability to prioritize and handle multiple projects, use independent judgement and take initiative
- Knowledge of FDA Quality System Regulation including 21 CFR Part 11 and adherence to quality standards
- Knowledge of other software applications
- Experience across multiple therapeutic areas
What We Do
About Worldwide Clinical Trials Worldwide Clinical Trials is a global, midsize contract research organization (CRO) that provides top-performing bioanalytical and Phase I-IV clinical development services to the biotechnology and pharmaceutical industries. Founded in 1986 by physicians committed to advancing medical science, our full-service clinical experience ranges from early phase and bioanalytical sciences through late phase studies, post approval, and real-world evidence. Major therapeutic areas of focus include cardiovascular, metabolic, neuroscience, oncology, and rare diseases. Operating in 60+ countries with offices in North and South America, Eastern and Western Europe, and Asia, Worldwide is powered by its more than 3,000 employee experts. For more information, please visit www.worldwide.com or connect with us on Twitter, LinkedIn, Facebook, and Instagram.
