[Hiring] Principal Statistician @Worldwide Clinical Trials

Role Description

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.

• 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.
• 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.
• 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.

Qualifications

• 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.

Requirements

• 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.

Benefits

• 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.