Sr/Principal Statistician in Spain at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr/Principal Statistician based in Spain.

This is a senior-level opportunity within a global clinical research environment where statistical expertise directly contributes to the development of life-changing therapies. In this role, you will support clinical trials from protocol design through study completion, ensuring the integrity, quality, and scientific validity of statistical outputs. You will collaborate closely with cross-functional teams including clinical, programming, and regulatory experts, playing a key role in shaping study design and analysis strategies. The position combines technical leadership, hands-on statistical work, and cross-team coordination within a fast-paced, regulated environment. You will also contribute to the development of statistical analysis plans, oversight of deliverables, and interpretation of clinical trial data. This role is ideal for an experienced statistician seeking to influence global drug development programs while mentoring peers and ensuring the highest standards of analytical rigor.

• Lead and support statistical activities across the full clinical study lifecycle, from protocol development through Clinical Study Report (CSR) completion.
• Develop Statistical Analysis Plans (SAPs), including mock tables, listings, and figures, ensuring clarity and alignment with study objectives and regulatory expectations.
• Contribute to protocol design, randomization strategies, and statistical input for clinical trial documentation and publications.
• Oversee and review statistical programming outputs, including analysis datasets, tables, listings, and figures for accuracy and compliance with specifications.
• Collaborate with sponsors and cross-functional teams to ensure robust study design and high-quality statistical deliverables.
• Coordinate and review the work of other biostatistics and statistical programming team members to ensure consistency and timely delivery.
• Conduct quality control and verification of study outputs, ensuring alignment with SAPs, protocols, and regulatory standards.
• Serve as a biostatistics representative on study teams, contributing to project planning, meetings, and cross-functional discussions.
• Monitor project timelines, manage multiple studies concurrently, and proactively escalate risks or delays when necessary.
• Support regulatory interactions, data monitoring committees, and integrated analyses when required.
• Contribute to business development activities, including proposal development, budgeting, and bid defense meetings.
• Mentor and coach junior biostatistics staff, supporting knowledge sharing and capability development.

• Advanced degree (Master’s or PhD) in Statistics, Biostatistics, Mathematics, or a related quantitative field.
• Extensive experience as a statistician in clinical trials within the pharmaceutical, biotech, or CRO industry.
• Strong expertise in statistical methodology applied to clinical research, including study design, analysis planning, and interpretation of results.
• Experience preparing Statistical Analysis Plans (SAPs), clinical trial protocols, and regulatory submission documentation.
• Proficiency in SAS programming and familiarity with clinical trial data structures, analysis datasets, and reporting outputs.
• Solid understanding of regulatory guidelines (e.g., ICH) and Good Clinical Practice (GCP) requirements.
• Experience coordinating cross-functional teams and reviewing the work of statisticians and programmers.
• Strong organizational and time management skills with the ability to handle multiple complex studies simultaneously.
• Excellent communication skills with the ability to explain complex statistical concepts to non-statistical stakeholders.
• Experience contributing to regulatory submissions, DSMB/DMC activities, or integrated analyses is highly desirable.
• Leadership capabilities with mentoring or team coordination experience preferred.
• Fluency in English, both written and spoken.

• Competitive compensation package aligned with senior-level expertise in clinical statistics.
• Flexible working arrangements across EMEA, including remote options.
• Opportunity to work on global clinical trials contributing to innovative drug development programs.
• Exposure to regulatory interactions and high-impact clinical research activities.
• Career development and progression opportunities within a global life sciences environment.
• Collaborative, science-driven culture with strong cross-functional teamwork.
• Involvement in high-profile studies spanning multiple therapeutic areas and geographies.
• Opportunity to mentor and influence the next generation of biostatistics professionals.