Principal Statistician – EMEA, Sponsor-dedicated

This is a fully remote position, open to applicants in Spain.

📋 Description

• Act as a resource for the statistical department and mentor biostatisticians.

• Design and manage training plans and materials; facilitate training sessions.

• Supervise the activities of biostatistics personnel on designated projects and perform independent reviews of project work.

• Assist with statistical tasks throughout the entire clinical trial lifecycle, from protocol development to CSR completion.

• Prepare or oversee the creation of Statistical Analysis Plans along with mock-up tables, listings, and figures.

• Lead the statistical components of protocols, randomization schedules, and clinical study reports as necessary.

• Develop or evaluate programming specifications for analysis datasets, tables, listings, and figures.

• Review SAS/R annotated CRFs, database designs, and study documentation.

• Collaborate with representatives from cross-functional project teams.

• Execute verification and quality control of project deliverables.

• Manage complex or multiple projects, including submissions and integrated analyses.

• Attend meetings with regulatory agencies or address questions as required.

• Oversee schedules, priorities, milestones, timelines, and out-of-scope tasks.

• Provide statistical programming assistance as needed.

• Participate in or lead DSMB/DMC activities.

• Adhere to applicable SOPs, WIs, and regulatory guidelines.

• Maintain comprehensive and current project and quality-control documentation for inspection readiness.

• Assist in business development efforts through proposals, budgets, and sponsor bid defense meetings.

• Perform other assigned work-related tasks.

⛳️ Requirements

• Graduate degree in biostatistics or a related field.

• Significant experience in clinical trials or a comparable combination of education and experience, evidenced by the ability to lead multiple projects and programs of studies.

• Proficient in R programming.

• Extensive understanding of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research.

• Ability to effectively convey statistical concepts.

• Familiarity with all statistical tasks necessary to support clinical trials throughout the project lifecycle, from protocol to CSR.

• Experience with regulatory submissions is preferred.

• Excellent written and verbal communication abilities.

• Proficient in reading, writing, speaking, and understanding English.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Technical and therapeutic area training provided.

• Recognition among peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Minimal travel may be required.