Principal Biostatistician – Integrated Analysis Experience Required

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

📋 Description

• Oversee projects spanning multiple studies or programs.

• Serve as the main contact for biostatistics activities for sponsors.

• Offer statistical consultancy and act as a resource for intricate statistical inquiries, study design, and protocol formulation.

• Guide biostatisticians and manage the creation of training materials and plans.

• Supervise biostatistics staff and conduct independent reviews of project deliverables.

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

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

• Manage 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-annotated Case Report Forms (CRFs), database designs, and study documentation.

• Collaborate with representatives from cross-functional project teams.

• Conduct verification and quality control of project outputs.

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

• Assist in regulatory agency meetings and address regulatory inquiries.

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

• Provide statistical programming assistance as necessary.

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

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

• Maintain comprehensive, up-to-date project and quality-control documentation to ensure inspection readiness.

• Aid in business development through the preparation of proposals, budgets, and sponsor bid defense meetings.

• Perform other assigned work-related tasks.

⛳️ Requirements

• A graduate degree in biostatistics or a related field – at least a Master’s degree.

• Practical experience with integrated analysis involving IASAP and TLF specifications, additional derivations, draft table reviews, and coordinating analyses for labeling support.

• Comprehensive understanding of clinical development plans and submission strategies, with experience in submission planning and Benefit/Risk analyses.

• Capability to independently handle requests from regulatory authorities and collaborate with clinical teams.

• Extensive experience in clinical trials or a comparable combination of education and experience.

• Proficiency in programming.

• In-depth knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques used in clinical research.

• Experience in all statistical tasks supporting clinical trials from protocol development to CSR.

• Previous experience with regulatory submissions is preferred.

• Exceptional written and verbal communication skills.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Minimal travel may be required.