Senior Statistician, Sponsor-dedicated – Early Phase

This is a fully remote position, open to applicants in United Kingdom, +4 more states.

📋 Description

• Deliver assistance throughout the project lifecycle on designated statistical tasks, from protocol development to clinical study reporting.

• Develop Statistical Analysis Plans, which include mock-up tables, listings, and figures.

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

• Coordinate biostatistics and statistical programming teams to ensure timely and high-quality output.

• Independently evaluate project work generated by fellow biostatisticians.

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

• Review annotated case report forms, database designs, and study documentation.

• Conduct verification and quality control of project deliverables.

• Act as the biostatistics representative within project teams.

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

• Provide statistical programming assistance as required.

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

• Lead integrated analysis projects and support regulatory agency meetings or responses as necessary.

• Maintain project documentation and quality-control records to ensure inspection readiness.

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

• Guide and mentor Biostatistics personnel.

• Carry out other assigned job-related responsibilities.

⛳️ Requirements

• Proficiency and experience in biostatistics and statistical programming.

• Capability to create Statistical Analysis Plans along with mock-up tables, listings, and figures.

• Understanding of clinical trial protocols, randomization schedules, publications, and clinical study reports.

• Ability to develop or evaluate programming specifications for analysis datasets, tables, listings, and figures.

• Experience in reviewing SAS-annotated case report forms, database designs, and study documentation.

• Familiarity with verification and quality control processes for project deliverables.

• Skill in managing multiple projects while overseeing schedules, milestones, timelines, and adapting to changing priorities.

• Knowledge of relevant SOPs, work instructions, and regulatory guidelines such as ICH.

• Ability to keep comprehensive and current project documentation for inspection readiness.

• Proficient statistical programming skills.

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

• Ability to assist in regulatory agency meetings and responses.

• Some travel may be required.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and total rewards initiatives.

• An inclusive workplace culture.

• Access to comprehensive resources, including emerging technologies, data, and knowledge-sharing.

• Global career paths and employment opportunities.

• Some travel may be required.