Principal Statistician – UK/Europe

This is a fully remote position, open to applicants in Spain, +4 more countries.

📋 Description

• Review study designs, analysis plans, and reports.

• Contribute to the design of clinical trials, including statistical sections of protocols, randomization methodologies, and Statistical Analysis Plans.

• Provide guidance on essential elements of study design and analysis.

• Assist in statistics reporting by specifying/reviewing tables, figures, listing shells, derived dataset specifications, report documents, and tabulations.

• Prepare final reports, encompassing tables, figures, listings, and report writing.

• Develop, test, and execute SAS programs for the statistical analysis of clinical study data.

• Create programs for derived datasets, SDTM/ADaM datasets, tables, figures, listings, and related validation processes.

• Identify improvements in systems and processes, and create and implement solutions for efficiency and quality.

• Manage statistical support for projects or sponsor programs through timely consultancy and assistance.

• Conduct activities in compliance with WCT, sponsor quality systems, ICH standards, and FDA Quality System Regulation, including 21 CFR Part 11.

• Collaborate with internal departments, sponsors, and third parties on statistical issues and reporting requirements.

• Utilize current statistical methods, regulations, and software application knowledge.

• Review budgets and identify out-of-scope or unbudgeted items.

⛳️ Requirements

• Proficient in computer systems and numerically adept, with the ability to adapt to various software.

• Comprehensive knowledge of SAS.

• Familiarity with other software applications is advantageous.

• Possess consultancy and facilitation skills.

• Customer-focused, committed to delivering on promises, skilled in relationship building, communication, influencing, and embracing innovation and change.

• Relevant educational qualifications and experience: BSc with 8 years, MSc with 6 years, or PhD with 4 years.

• Expert-level project statistician with hands-on experience in providing statistical leadership.

• Extensive statistical applications experience across all phases of clinical research.

• Thorough understanding of regulatory standards and experience with regulatory interactions.

• Strong oral and written communication, organizational skills, and personal presentation.

• Proficient in effective communication in English.

• Ability to prioritize and manage multiple projects simultaneously.

• Flexible mindset, sound independent judgment, and initiative to evaluate information.

• Experience across various therapeutic areas.

🏝️ Benefits

• A diverse and inclusive workplace.

• Accessible, hands-on leadership.

• Supportive and cohesive team environment.

• Opportunities to enhance knowledge of SAS and CDISC standards throughout all phases of clinical trials.

• Autonomy and active involvement in projects.

• Support for personal and professional growth.

• Equal employment opportunities.

• Exceptional employee experiences.

• Access to equal opportunity resources.