Senior Statistician

Worldwide Clinical Trials•Carolina, NC

About The Position

Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries and innovates to find cures for diseases. We are a global team of over 3,500+ experts dedicated to changing the way the world experiences CROs. Our mission is to work with passion and purpose every day to improve lives. We believe everyone plays an important role in making a world of difference for patients and their caregivers. We are committed to enabling professionals from all backgrounds and experiences to succeed and prioritize cultivating a diverse and inclusive environment that promotes 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.

Requirements

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.

Responsibilities

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.