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 Senior Statistician does at WorldwideIndependently manages statistical project support and provides expert statistical consultancy across the stats function.
What you will do
Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are met by expert and timely statistical consultancy and support
Provides expert review of study designs, analysis plans, and reports
Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomization methodology, and writing statistical analysis plans
Consult with internal departments, sponsors, and other third parties regarding statistical issues and reporting requirements
Provide project support to the statistics reporting process through the specification/review of tables, figures, and listings shells, writing/review of derived dataset specifications, and the formatting of report documents and tabulations
Undertake the preparation of final reports, including the production of tables, listings, and figures, and report writing
Develop, evaluate, and run Statistical Analysis System (SAS) programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM), and Analysis Data Model (ADaM) datasets, tables, figures, and listings, and their validation
Ensure the maintenance of documentation, e.g., the description of programs and validation
Produce ad hoc data summaries when requested during a trial.
Extract information from the system during a trial, e.g., summaries, data listings, study data sets.Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation
Make statistical contributions to manuscripts for publication/presentation
Provide support for the bidding process, including contribution to budget review, proposals, and bid defense meetings
Lead the identification of system and process improvements, and develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting
Support the development of statistical design and analysis policies
Maintain knowledge in design consultancy and analysis methodology, statistical software packages (e.g., SAS and nQuery), and regulatory guidance documents, e.g. International Council for Harmonization (ICH), Food and Drug Administration (FDA), and Committee for Medicinal Products (CPMP) points to consider
Assist with Quality Assurance and Audit requirements
Assist the Director of Biostatistics with all other aspects of the job as required
Perform all activities in compliance with Worldwide Clinical Trials and agreed sponsor quality system standards, relevant ICH standards, and specifically with FDA Quality System Regulation (including 21CFR Part 11)
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
What you bring to the role:
Computer literate and numerate with a proven ability to adapt to various computer systems
Expert-level project statistician experienced in providing statistical leadership to projects
Design and analysis consultancy skills and knowledge across a broad range of applications, together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating, influencing, and embracing innovation and change
Your experience
Master's level in mathematics, statistics, or another subject required with a strong statistical component
Minimum 3 years of statistical experience leading clinical trial projects and data analysis
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.
Worldwide Clinical Trials Austin, Texas, USA Office
Austin, United States
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