[Hiring] Senior Statistician @Worldwide Clinical Trials

Role Description

Independently manages statistical project support and provides expert statistical consultancy across the stats function.

• 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.
• 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.
• 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.

Qualifications

• 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.
• Key competencies in customer focus, delivering on commitments, building strong relationships, communicating, influencing, and embracing innovation and change.

Requirements

• 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.

Benefits

• Competitive benefits package depending on location.
• Salary range for this position is $87,500.00 - $173,500.00 annually.
• Compensation will fall within the provided range based on relevant experience, performance, education, and internal equity.
• Pay equity and transparency compliance with all applicable labor laws.