Principal Statistician, Biostatistics

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

📋 Description

• Assist in the design and reporting of Phase I to IV clinical trials.

• Aid in regulatory submissions under the guidance of a senior statistician.

• Oversee the statistical dimensions of study design, analysis, validation, and documentation.

• Offer statistical expertise for clinical trials, including early-phase studies.

• Create and implement statistical strategies, designs, and analyses.

• Collaborate with teams in clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.

• Supervise statistical and programming work conducted by external vendors.

• Engage in data science and cross-functional discussions to enhance study designs, endpoints, and analysis approaches.

• Assist in the preparation of study protocols and review and validate study-specific data capture systems.

• Develop statistical programs for simulations, analyses, data visualization, and validation related to clinical trials.

• Compose statistical analysis plans, execute data analysis and validation, and interpret the results.

• Support the lead statistician on projects.

• Prepare for and participate in regulatory agency meetings, addressing statistical inquiries.

• Collaborate closely with statistical programming colleagues.

• Monitor CRO guidelines and standards, reviewing and validating CRO deliverables.

• Work with medical writers on clinical reports, integrated summaries, and various documents.

• Acquire and apply knowledge of drug development regulatory requirements, including CDISC SDTM and ADaM standards.

• Keep abreast of advancements in statistics, drug development, and regulatory guidance through literature reviews, conference participation, and professional development.

⛳️ Requirements

• Proficient understanding of clinical trial design and analysis, including sophisticated statistical methods and models.

• Familiarity with statistical principles and methodologies, encompassing statistical inference, hypothesis testing, estimates, parametric and non-parametric models, sample size calculations, experimental design, and data analysis for Phase II-IV clinical trials.

• Experience with SAS and R; knowledge of additional statistical software and programming languages is advantageous.

• Awareness of relevant regulatory requirements and guidelines, such as ICH Guidelines.

• MSc in statistics, mathematics, or a related field with a statistical focus and over 2 years of experience in the pharmaceutical or biotechnology industry, or a PhD in statistics, mathematics, or a related discipline with a statistical focus and less than 2 years of experience in the pharmaceutical or biotechnology industry.

• Understanding of drug development regulations related to statistical analysis.

• Strong SAS and R programming capabilities.

• Knowledge of CDISC models and standards.

• Excellent writing, communication, interpersonal, and leadership abilities.

• Capacity to thrive in a fast-paced, adaptable, team-oriented setting.

• Keen attention to detail.

• Capability to work independently with strong time management skills.

🏝️ Benefits

• Medical, dental, and vision insurance.

• Retirement savings plan.

• Flexible paid vacation.