Senior Statistician

Worldwide Clinical Trials•Durham, NC

1d•$87,500 - $173,500

About The Position

Worldwide Clinical Trials is a global, midsize CRO that is dedicated to pushing boundaries and innovating to find cures for diseases. As a Senior Statistician, you will independently manage statistical project support and provide expert statistical consultancy across the statistics function. You will play a crucial role in managing statistical support for projects, ensuring timely and expert consultancy, and contributing to the design and analysis of clinical trials. This role involves collaborating with internal departments, sponsors, and third parties, developing and validating SAS programs, and contributing to the preparation of final reports and publications. You will also be involved in identifying and implementing process improvements, supporting bidding processes, and maintaining knowledge of regulatory guidance and statistical methodologies. All activities must be performed in compliance with Worldwide Clinical Trials and sponsor quality system standards, ICH standards, and FDA Quality System Regulation.

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.