Senior Statistician – Sponsor-dedicated, Early Phase

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

📋 Description

• Offer support for all assigned statistical tasks throughout the project lifecycle, from protocol development to Clinical Study Report (CSR).

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

• Collaborate with sponsors as necessary.

• Assist with the statistical components of protocols, randomization schedules, publications, and clinical study reports.

• Coordinate the efforts of biostatistics and statistical programming teams on assigned projects.

• Conduct independent reviews of project work produced by other biostatisticians.

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

• Examine SAS-annotated case report forms (CRFs), database design, and study documentation.

• Perform verification and quality control of project deliverables.

• Act as the biostatistics representative on project teams.

• Oversee scheduling and timelines across multiple projects.

• Track study activities against milestones and escalate out-of-scope tasks as necessary.

• Provide statistical programming support as required.

• Engage in Data Safety Monitoring Board and/or Data Monitoring Committee activities.

• Lead integrated analyses and assist with regulatory agency meetings or responses as required.

• Adhere to Standard Operating Procedures (SOPs), work instructions, ICH guidelines, and relevant regulatory requirements.

• Maintain thorough and up-to-date project and quality-control documentation for inspection readiness.

• Contribute to business development through proposals, budgets, and sponsor bid defense meetings.

• Mentor and coach Biostatistics staff.

• Carry out other assigned work-related responsibilities.

⛳️ Requirements

• Equivalent experience, skills, and/or education will be taken into account.

• Capability to execute assigned statistical tasks throughout the clinical trial project lifecycle.

• Proficiency in preparing Statistical Analysis Plans and mock-up tables, listings, and figures.

• Competence in supporting protocol statistics, randomization schedules, publications, and clinical study reports.

• Ability to coordinate and independently review biostatistical outputs.

• Experience in creating or reviewing programming specifications for analysis datasets, tables, listings, and figures.

• Familiarity with SAS-annotated case report forms, database design, and study documentation.

• Proficiency in performing verification and quality control of project deliverables.

• Knowledge of applicable SOPs, work instructions, ICH guidelines, and relevant regulatory standards.

• Skill in managing multiple project schedules, milestones, priorities, and timelines.

• Ability to provide statistical programming support.

• Capacity to participate in Data Safety Monitoring Board/Data Monitoring Committee activities.

• Competence in supporting regulatory agency meetings and responses.

• Ability to contribute to proposals, budgets, and sponsor bid defense meetings.

• Capability to mentor and coach Biostatistics staff.

• Minimal travel may be necessary.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged management structure.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Culture of inclusivity.

• Access to extensive resources, including emerging technologies, data, science, and knowledge sharing.

• Various career paths and employment opportunities.

• Collaboration with a global team.

• Minimal travel may be required.