Principal Statistician – Early Phase

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

📋 Description

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

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

• Guide biostatistics staff on assigned projects to guarantee timely and high-quality deliverables.

• Independently assess project outputs created by other biostatisticians.

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

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

• Lead the statistical components of protocols, randomization schedules, and clinical study reports when designated.

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

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

• Represent the biostatistics team in project meetings and collaborate with departmental representatives and sponsors.

• Conduct verification and quality control of project deliverables.

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

• Assist with regulatory agency meetings and responses concerning statistical analyses of clinical trials.

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

• Provide statistical programming assistance as required.

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

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

• Ensure complete and up-to-date project and quality-control documentation is maintained for inspection readiness.

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

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• A graduate degree in biostatistics or a closely related field.

• Significant experience in clinical trials or equivalent education and experience, demonstrated by leading multiple projects and study programs.

• Proficiency in R programming.

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

• Capability to effectively communicate statistical concepts.

• Experience in various statistical tasks that support clinical trials from protocol development through to CSR.

• Experience with regulatory submissions is preferred.

• Exceptional written and verbal communication abilities.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Minimal travel may be required.