Principal Statistician – Early Phase – Sponsor Dedicated – Program/Project Leader

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

📋 Description

• Leads the creation and implementation of a clinical development plan, which includes establishing a Go/No Go framework.

• Utilizes simulations and statistical strategies to guide and influence trial design decisions.

• Acts as a resource within the statistical department and mentors biostatisticians.

• Oversees the development of training plans and materials, and facilitates training sessions.

• Directs biostatistics personnel on designated projects and reviews project work independently.

• Provides assistance across statistical tasks throughout the entire project lifecycle, from protocol development to Clinical Study Report (CSR) preparation.

• Prepares or supervises Statistical Analysis Plans (SAPs), including mock-up displays for tables, listings, and figures.

• Functions as the Lead Biostatistician for the statistical components of protocols, randomization schedules, and inputs for clinical study reports.

• Creates or evaluates programming specifications for analysis datasets, tables, listings, and figures.

• Reviews SAS/R annotated Case Report Forms (CRFs), database designs, and study documentation.

• Implements company objectives and crafts solutions to business and operational challenges.

• Represents biostatistics on project teams and collaborates with representatives from other departments.

• Conducts verification and quality control of project deliverables.

• Manages complex or multiple projects and supports regulatory agency meetings or responses.

• Oversees schedules, priorities, timelines, and workloads across various projects.

• Monitors study milestones, deliverables, and tasks that fall outside the project scope.

• Provides statistical programming support as necessary.

• Participates in Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) activities, including charter development and taking on statistician roles.

• Adheres to relevant Standard Operating Procedures (SOPs), Work Instructions (WIs), and regulatory guidelines such as ICH.

• Keeps complete and current project and quality-control documentation for inspection readiness.

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

• Performs other assigned job-related responsibilities.

⛳️ Requirements

• Master's degree in biostatistics or a related field.

• Significant experience in clinical trials or an equivalent combination of education and experience, as evidenced by the ability to lead multiple projects and program studies.

• Leadership at the program/project level and contributions to clinical development strategy.

• Proficiency in R programming.

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

• Capability to communicate statistical concepts effectively.

• Experience with all statistical tasks required to support clinical trials throughout the project's lifecycle, from protocol to CSR.

• Experience with regulatory submissions is preferred.

• Excellent written and verbal communication skills.

• 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.

• Total rewards program offered.

• An inclusive organizational culture.

• Minimal travel may be required.