Independently manages statistical project support and provides expert statistical consultancy across the stats function. Manages 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. Assists sponsors in the design of clinical trials, including statistical sections of the study protocol, randomization methodology, and writing statistical analysis plans. Consults with internal departments, sponsors, and other third parties regarding statistical issues and reporting requirements. Provides 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. Undertakes the preparation of final reports, including the production of tables, listings, and figures, and report writing. Develops, evaluates, and runs 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. Ensures the maintenance of documentation, e.g., the description of programs and validation. Produces ad hoc data summaries when requested during a trial. Extracts information from the system during a trial, e.g., summaries, data listings, study data sets. Validates software, in the role of system owner or tester, and tests SAS Macros, maintaining the required validation and testing documentation. Makes statistical contributions to manuscripts for publication/presentation. Provides support for the bidding process, including contribution to budget review, proposals, and bid defense meetings. Leads the identification of system and process improvements, and develops and implements solutions to improve the efficiency and quality of clinical study data processing and reporting. Supports the development of statistical design and analysis policies. Maintains 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. Assists with Quality Assurance and Audit requirements. Assists the Director of Biostatistics with all other aspects of the job as required. Performs 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). Performs 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. 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.
At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually: United States of America - $87,500.00 - $173,500.00. The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it is not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.
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