Senior Biostatistician
About The Position
Independently manages statistical project support and provides expert statistical consultancy across the statistics function. This role involves managing the statistics support to one or more projects/sponsor programs of work, ensuring that needs are fully met through expert and timely statistical consultancy and support. The Senior Biostatistician will provide expert review of study designs, analysis plans, and reports, and assist sponsors in the design of clinical trials, including statistical sections of study protocols, randomization methodology, and writing statistical analysis plans. They will liaise with internal departments, sponsors, and other third parties regarding statistical issues and reporting requirements, and provide project support to the statistics reporting process through the specification and review of tables, figures, and listings shells, writing and reviewing derived dataset specifications, and formatting report documents and tabulations. The role also includes undertaking the preparation of final reports, developing, testing, and running SAS programs for statistical analysis and reporting of clinical study data, ensuring the maintenance of documentation, producing ad hoc data summaries, extracting information from systems, validating software, making statistical contributions to manuscripts, providing support for the bidding process, leading the identification of system and process improvements, supporting the development of statistical design and analysis policies, and maintaining knowledge of design consultancy and analysis methodology, statistical software packages, and regulatory guidance documents. Additionally, the Senior Biostatistician will assist with Quality Assurance and audit requirements, assist the Director of Biostatistics, and perform all activities in compliance with Worldwide Clinical Trials and agreed sponsor quality system standards, relevant ICH standards, and specifically with FDA Quality System Regulations, including 21 CFR Part 11.
Requirements
- Computer literate and numerate, with a proven ability to adapt to various computer systems
- Hands-on 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 and influencing, and embracing innovation and change
- Educated to degree level in mathematics, statistics, or another subject with a strong statistical component
Responsibilities
- Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are fully met through expert and timely statistical consultancy and support
- Provide expert review of study designs, analysis plans, and reports
- Assist sponsors in the design of clinical trials, including statistical sections of study protocols, randomization methodology, and writing statistical analysis plans
- Liaise 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 and review of tables, figures, and listings shells, writing and reviewing derived dataset specifications, and formatting report documents and tabulations
- Undertake the preparation of final reports, including the production of tables, listings, figures, and report writing
- Develop, test, and run SAS programs for the statistical analysis and reporting of clinical study data, including programs for derived datasets, CDISC SDTM and ADaM datasets, tables, figures, listings, and their validation
- Ensure the maintenance of documentation, including descriptions of programs and validation
- Produce ad hoc data summaries when requested during the course of a trial
- Extract information from systems during the course of a trial, including summaries, data listings, and study datasets
- Validate software in the role of system owner or tester, and test SAS macros while maintaining the required validation and testing documentation
- Make statistical contributions to manuscripts for publication and 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 of design consultancy and analysis methodology, statistical software packages (e.g., SAS and nQuery), and regulatory guidance documents, including ICH, FDA, and 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 Regulations, including 21 CFR Part 11
- Perform other duties as assigned.
Benefits
- Competitive benefits package depending on location
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What This Job Offers
Job Type
Full-time
Career Level
Senior
