Senior Statistician

About This Opportunity

Our talent team at Get A Job.ai is representing a confidential client in the clinical research sector. They are seeking a Senior Statistician to independently manage statistical project support and provide expert consultancy across their statistics function. This role is available in the UK or USA and offers the opportunity to make a meaningful impact on clinical trial outcomes.

Responsibilities

• Manage statistical support for one or more clinical trial projects, ensuring timely and expert statistical consultancy
• Provide expert review of study designs, analysis plans, and clinical reports
• Collaborate on the design of clinical trials, including statistical sections of protocols, randomization methodology, and statistical analysis plans
• Consult with internal teams and external parties on statistical issues and reporting requirements
• Support the statistics reporting process through specification and review of tables, figures, and listings shells
• Prepare final reports including production of tables, listings, figures, and report writing
• Develop, evaluate, and run Statistical Analysis System (SAS) programs for analysis and reporting of clinical study data
• Create and validate programs for derived datasets, CDISC SDTM and ADaM datasets, tables, figures, and listings
• Maintain comprehensive documentation including program descriptions and validation records
• Produce ad hoc data summaries and extract information from systems during trials
• Validate software and test SAS Macros, maintaining required validation and testing documentation
• Contribute to manuscripts for publication and presentation
• Support bidding processes including budget review, proposals, and bid defense meetings
• Lead identification of system and process improvements to enhance efficiency and quality
• Support development of statistical design and analysis policies
• Maintain knowledge of design consultancy, analysis methodology, statistical software packages, and regulatory guidance (ICH, FDA, CPMP)
• Assist with Quality Assurance and Audit requirements

What We're Looking For

• Master's degree in mathematics, statistics, or a related subject with strong statistical component
• Minimum 3 years of statistical experience leading clinical trial projects and data analysis
• Expert-level experience providing statistical leadership to clinical research projects
• Design and analysis consultancy skills across a broad range of applications
• Strong proficiency with SAS programming and statistical software packages (e.g., nQuery)
• Knowledge of CDISC standards (SDTM, ADaM) and regulatory guidance documents
• Computer literate and numerate with proven ability to adapt to various computer systems
• Excellent customer focus, communication, and relationship-building skills
• Experience with FDA Quality System Regulation including 21CFR Part 11
• Ability to deliver on commitments and embrace innovation and change

How We Work With You

When you apply through Get A Job.ai, our recruiting team will review your qualifications and conduct an initial screening. If there's a strong match, we'll submit your profile to our client for consideration. Please note that all applications must go through Get A Job.ai—candidates who contact the client directly cannot be considered for this position.

Pay

Pay details will be discussed during the interview process based on your experience, qualifications, and location.

Equal Employment Opportunity: Get A Job.ai is committed to fostering an inclusive recruitment process. We welcome applications from candidates of all backgrounds and experiences.