Biostatistician II

Biostatistician II

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

What you will do

1. 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
2. Provide expert review of study designs, analysis plans, and reports
3. Assist sponsors in the design of clinical trials, including statistical sections of study protocols, randomization methodology, and writing statistical analysis plans
4. Liaise with internal departments, sponsors, and other third parties regarding statistical issues and reporting requirements
5. 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
6. Undertake the preparation of final reports, including the production of tables, listings, figures, and report writing
7. Develop, test, and run SAS programs for the statistical analysis and reporting of clinical study data, including programs for derived datasets, Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets, tables, figures, listings, and their validation
8. Ensure the maintenance of documentation, including descriptions of programs and validation
9. Produce ad hoc data summaries when requested during the course of a trial
10. Extract information from systems during the course of a trial, including summaries, data listings, and study datasets
11. Validate software in the role of system owner or tester, and test SAS macros while maintaining the required validation and testing documentation
12. Make statistical contributions to manuscripts for publication and presentation
13. Provide support for the bidding process, including contribution to budget review, proposals, and bid defense meetings
14. 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
15. Support the development of statistical design and analysis policies
16. Maintain knowledge of design consultancy and analysis methodology, statistical software packages (e.g., SAS and nQuery), and regulatory guidance documents, including International Council for Harmonisation (ICH), Food and Drug Administration (FDA), and Committee for Proprietary Medicinal Products (CPMP) points to consider
17. Assist with Quality Assurance and audit requirements
18. Assist the Director of Biostatistics with all other aspects of the job as required
19. Perform all activities in compliance with Worldwide Clinical Trials and agreed sponsor quality system standards, relevant International Council for Harmonisation (ICH) standards, and specifically with Food and Drug Administration (FDA) Quality System Regulations, including 21 CFR Part 11
20. Perform 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

• The job holder must be 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, together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change

Your experience

• Educated to degree level in mathematics, statistics, or another subject with a strong statistical component
• Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

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 (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $0.00 - $1,000,000.00. The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it 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.